Clinical Trials /

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

NCT03621982

Description:

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Esophagogastric Carcinoma
  • Head and Neck Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
  • Official Title: A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: ADCT-301-103
  • SECONDARY ID: 2019-003132-23
  • NCT ID: NCT03621982

Conditions

  • Advanced Solid Tumors With Literature Evidence of CD25(+) Treg Content
  • Head and Neck Cancer Squamous Cell Carcinoma
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Pancreas Cancer
  • Bladder Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Triple-negative Breast Cancer
  • Ovarian Cancer
  • Colo-rectal Cancer
  • Fallopian Tube Cancer

Interventions

DrugSynonymsArms
ADCT-301Camidanlumab tesirinePart 1: Dose Escalation, ADCT-301 Combination Therapy
PembrolizumabKeytrudaPart 1: Dose Escalation, ADCT-301 Combination Therapy

Purpose

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

Detailed Description

      This is a Phase 1b, multi-center, open-label study with a dose-escalation part and a dose
      expansion part.

      The duration of the study participation for each patient is defined as the time from the date
      of signed written informed consent to the completion of the follow-up period, withdrawal of
      consent, loss to follow-up, or death, whichever occurs first.

      The study will include a Screening Period (of up to 21 days), a Treatment Period (with cycles
      of 3 weeks for a Q3W dosing regimen), and a Follow-up Period (approximately every 12 week
      visits) for up to 1 year after treatment discontinuation
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation, ADCT-301 MonotherapyExperimentalIn Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 as monotherapy.
  • ADCT-301
Part 1: Dose Escalation, ADCT-301 Combination TherapyExperimentalIn Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 in combination with pembrolizamab as combination therapy.
  • ADCT-301
  • Pembrolizumab
Part 2: Dose expansion, ADCT-301 Combination TherapyExperimentalIn Part 2 (dose expansion), patients will receive ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation). Patients will be split into two groups: Group 1: One of the indications identified in Part 1, for which at least 1 response (PR or CR) was seen. Group 2: a basket group with the same indications allowed in Part 1, where patients will be treated with ADCT-301 in combination with pembrolizumab with the exception for the one selected for Group 1.
  • ADCT-301
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent must be obtained prior to any procedures.

          2. Male or female patient aged 18 years or older.

          3. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic
             at time of Screening:

             Part 1 Dose escalation camidanlumab tesirine as monotherapy:

             Selected advanced solid tumors: colorectal, head and neck, NSCLC, gastric and
             esophageal cancers, pancreas, bladder, renal cell carcinoma, melanoma, TNBC, and
             ovarian/fallopian tube cancers

             Part 1 Dose-escalation camidanlumab tesirine in combination with pembrolizumab:

             Selected advanced solid tumors: colorectal cancer, gastric-esophageal cancer, ovarian
             /fallopian tube cancer, pancreatic cancer, non-small cell lung cancer, and melanoma.

             Note: For colorectal cancer, gastric-esophageal cancer, ovarian/fallopian tube cancer,
             pancreatic cancers mismatch repair (MMR) / microsatellite stability (MSS) /
             microsatellite instability (MSI) status is mandatory. If MMR/MSS/MSI status is not
             available at signature of the informed consent, the test should be performed before
             Cycle 1 Day 1 (C1D1).

             Part 2 Dose expansion camidanlumab tesirine in combination with pembrolizumab:

               -  Group 1: One of the indications identified in Part 1, for which at least 1
                  response (PR or CR) was seen.

               -  Group 2: Selected advanced solid tumors: colorectal cancer, gastric-esophageal
                  cancer, ovarian/fallopian tube cancer, pancreatic cancer, non-small cell lung
                  cancer, melanoma, with the exception for the one selected for Group 1.

             Note: For colorectal cancer, gastric-esophageal cancer, ovarian/fallopian tube cancer,
             pancreatic cancers MMR/MSS/MSI status is mandatory. If MMR/MSS/MSI status is not
             available at signature of the informed consent, the test should be performed before
             C1D1.

          4. Patients who are refractory to or intolerant of existing therapy(ies) known to provide
             clinical benefit for their condition.

          5. Patients with advanced/metastatic cancer, with measurable disease as determined by
             RECIST v1.1 or immune-related Response Criteria (irRC)/ immune-related Response
             Evaluation Criteria In Solid Tumors (irRECIST)/ immune-related Response Evaluation
             Criteria In Solid Tumors (iRECIST)/ immune-modified Response Evaluation Criteria in
             Solid Tumors (imRECIST) as per Investigator discretion.

          6. A) For camidanlumab tesirine as monotherapy: Patient must have a site of disease
             amenable to biopsy and be willing to undergo fresh biopsy procedures (minimum 3 passes
             each) prior to first dose, according to the treating institution's guidelines.

             B) Patients included in the paired-biopsy cohort must in addition be willing to
             undergo fresh biopsy procedures (minimum 3 passes each) after receiving at least 1
             dose of study drug.

             C) For camidanlumab tesirine in combination with pembrolizumab: Patient must have a
             site of disease amenable to biopsy and must provide fresh tumor biopsy prior to C1D1,
             and be willing to undergo fresh biopsy procedures (minimum 3 passes each) after
             receiving at least 1 dose of study treatment, according to the treating institution's
             guidelines.

          7. ECOG performance status 0-1.

          8. Patient with life expectancy ≥ 3 months as per Investigator assessment.

          9. Adequate organ function as defined by screening laboratory values within the following
             parameters:

               1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL (off growth factors at least 72
                  hours).

               2. Platelet count ≥100 × 10^3/μL without transfusion in the past 10 days.

               3. Hemoglobin ≥9 g/dL (5.6 mmol/L) (prior transfusion allowed).

               4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma
                  glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN) if there is no
                  liver involvement; ALT or AST ≤5 × ULN if there is liver involvement.

               5. Total bilirubin ≤1.5 × ULN (patients with known Gilbert's syndrome may have a
                  total bilirubin up to ≤3 × ULN with direct bilirubin ≤1.5 × ULN).

               6. Blood creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min by the
                  Cockcroft-Gault equation.

         10. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior
             to start of study drug for women of childbearing potential (WOCBP).

         11. Women of childbearing potential must agree to use a highly effective method of
             contraception from the time of giving informed consent until at least 6.5 months after
             the last dose of camidanlumab tesirine or 4 months after last dose of pembrolizumab,
             whichever is the latest. Men with female partners who are of childbearing potential
             must agree to use a condom when sexually active or practice total abstinence from the
             time of giving informed consent until at least 16 weeks after the patient receives his
             last dose of camidanlumab tesirine or 4 months after last dose of pembrolizumab,
             whichever is the latest.

        Exclusion Criteria:

          1. Participation in another investigational interventional study.

          2. Prior therapy with a CD25 (IL-2R) antibody within the last 4 months.

          3. Known history of ≥Grade 3 hypersensitivity to a therapeutic antibody.

          4. Patients with prior solid organ or allogeneic bone marrow transplant.

          5. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic
             progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome,
             autoimmune vasculitis [e.g., Wegener's granulomatosis]) (patients with vitiligo, type
             1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition
             only requiring hormone replacement may be enrolled).

          6. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy
             including Guillain-Barré syndrome and myasthenia gravis) or other central nervous
             system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis).

          7. History of recent infection (within 4 weeks of C1D1) caused by a pathogen known to be
             associated with GBS, for example: herpes simplex virus 1/2 (HSV1, HSV2), varicella
             zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles,
             Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter
             jejuni, enterovirus D68, or severe acute respiratory syndrome coronavirus 2
             (SARS-CoV-2).

             Note: An influenza test and a pathogen-directed SARS-CoV-2 test (such as polymerase
             chain reaction [PCR]) are mandatory and must be negative before initiating study
             treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional
             2 days are allowed in the event of logistical issues for receiving the results on
             time).

          8. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV)
             virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Note: Testing is not
             mandatory to be eligible but should be considered in patients with high risk for these
             infections; testing is mandatory if status is unknown.

          9. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.

         10. Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events version
             4.0 [CTCAE version 4.0]) from acute nonhematologic toxicity (to ≤Grade 2 for
             neuropathy or alopecia), due to previous therapy, prior to screening.

         11. Symptomatic CNS metastases or evidence of leptomeningeal disease (brain MRI or
             previously documented cerebrospinal fluid [CSF] cytology). Previously treated
             asymptomatic CNS metastases are permitted provided that the last treatment (systemic
             anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1
             except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or
             equivalent on Day 1 and consecutive days is permissible if being tapered down).
             Patients with discrete dural metastases are eligible.

         12. Clinically significant third space fluid accumulation (i.e., ascites requiring
             drainage or pleural effusion that is either requiring drainage or associated with
             shortness of breath).

         13. Active diarrhea CTCAE Grade 2 or a medical condition associated with chronic diarrhea
             (such as irritable bowel syndrome, inflammatory bowel disease).

         14. Active infection requiring systemic antibiotic therapy.

         15. Active bleeding diathesis or significant anticoagulation (international normalized
             ratio [INR] ≥2.0).

         16. Breastfeeding or pregnant.

         17. Significant medical comorbidities, including uncontrolled hypertension (blood pressure
             [BP] ≥160 mmHg systolic and/or ≥110 mmHg diastolic repeatedly with or without anti
             hypertensive medication), unstable angina, congestive heart failure (greater than New
             York Heart Association class II), electrocardiographic evidence of acute ischemia,
             coronary angioplasty or myocardial infarction within 6 months prior to screening,
             severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled
             diabetes, active ulceration of the upper gastrointestinal (GI) tract or GI bleeding,
             or severe chronic pulmonary disease.

         18. Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14
             days prior to start of study drug (C1D1), except shorter if approved by the Sponsor.
             For cytotoxic agents that have major delayed toxicity, e.g., mitomycin C and
             nitrosoureas, 4 weeks is indicated as washout period. For patients receiving systemic
             anticancer immunotherapies (as opposed to intralesional) that lead to activation of
             Teffs and/or increase the Teff/Treg ratio, such as anti-PD-1 antibodies, 4 weeks are
             indicated as the washout period.

         19. Use of any other experimental medication within 14 days prior to start of study drug
             (C1D1).

         20. Patients requiring concomitant immunosuppressive agents or chronic treatment with
             corticosteroids except:

               -  replacement dose steroids in the setting of adrenal insufficiency

               -  topical, inhaled, nasal, and ophthalmic steroids are allowed.

         21. Planned live vaccine within 30 days prior to the first dose of study treatment and
             during study treatment.

         22. Congenital long QT syndrome, or a corrected QTcF interval of ≥ 480 ms, at screening
             (unless secondary to pacemaker or bundle branch block).

         23. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic
             prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the
             breast, or other malignancy that the Sponsor's medical monitor and Investigator agree
             and document should not be exclusionary.

         24. Any other significant medical illness, abnormality, or condition that would, in the
             Investigator's judgment, make the patient inappropriate for study participation or put
             the patient at risk.

         25. For patients treated with camidanlumab tesirine in combination with pembrolizumab:
             patients intolerant to checkpoint-inhibitor or with a history of the following ≥ Grade
             3 immune-related adverse events: hepatitis, renal, ocular, neurologic, cardiovascular,
             rheumatologic, and hematologic.

         26. For patient treated with camidanlumab tesirine in combination with pembrolizumab:
             patients with a history of non-infectious pneumonitis related to prior systemic
             treatment and that require treatment with steroids within the last 6 months prior to
             enrollment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 Monotherapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE)
Time Frame:Up to 3 years
Safety Issue:
Description:An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier.

Secondary Outcome Measures

Measure:Part 1 Monotherapy: Overall Response Rate (ORR)
Time Frame:Up to 3 years
Safety Issue:
Description:ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Combination Therapy: Overall Response Rate (ORR)
Time Frame:Up to 3 years
Safety Issue:
Description:ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 2 Combination Therapy: Overall Response Rate (ORR)
Time Frame:Up to 3 years
Safety Issue:
Description:ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Monotherapy: Duration of Response (DOR)
Time Frame:Up to 3 years
Safety Issue:
Description:DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Combination Therapy: Duration of Response (DOR)
Time Frame:Up to 3 years
Safety Issue:
Description:DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 2 Combination Therapy: Duration of Response (DOR)
Time Frame:Up to 3 years
Safety Issue:
Description:DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Monotherapy: Progression-free survival (PFS)
Time Frame:Up to 3 years
Safety Issue:
Description:PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Combination Therapy: Progression-free survival (PFS)
Time Frame:Up to 3 years
Safety Issue:
Description:PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 2 Combination Therapy: Progression-free survival (PFS)
Time Frame:Up to 3 years
Safety Issue:
Description:PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measure:Part 1 Monotherapy: Overall Survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:OS is defined as the time between the start of treatment and death from any cause.
Measure:Part 1 Combination Therapy: Overall Survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:OS is defined as the time between the start of treatment and death from any cause.
Measure:Part 2 Combination Therapy: Overall Survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:OS is defined as the time between the start of treatment and death from any cause.
Measure:Part 1 Monotherapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-τ) Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-τ) Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-τ) Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Clearance (CL) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Clearance (CL) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Clearance (CL) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Combination Therapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 2 Combination Therapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum
Time Frame:Up to 3 years
Safety Issue:
Description:Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.
Measure:Part 1 Monotherapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses
Time Frame:Up to 3 years
Safety Issue:
Description:ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Measure:Part 1 Combination Therapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses
Time Frame:Up to 3 years
Safety Issue:
Description:ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Measure:Part 2 Combination Therapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses
Time Frame:Up to 3 years
Safety Issue:
Description:ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ADC Therapeutics S.A.

Trial Keywords

  • Camidanlumab tesirine

Last Updated

July 13, 2021