Clinical Trials /

Study of SO-C101 and SO-C101in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

NCT04234113

Description:

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Related Conditions:
  • Anal Carcinoma
  • Biliary Tract Carcinoma
  • Bladder Carcinoma
  • Breast Carcinoma
  • Cervical Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Renal Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Small Cell Lung Carcinoma
  • Thymic Carcinoma
  • Thyroid Gland Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of SO-C101 and SO-C101in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors
  • Official Title: A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SC103
  • NCT ID: NCT04234113

Conditions

  • Thyroid
  • Renal Cell Carcinoma
  • Non Small Cell Lung Cancer
  • Small-cell Lung Cancer
  • Bladder Cancer
  • Melanoma
  • Merkel Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Microsatellite Instability High
  • Triple Negative Breast Cancer
  • Mesothelioma
  • Thymic Cancer
  • Cervical Cancer
  • Biliary Tract Cancer
  • Hepatocellular Carcinoma
  • Ovarian Cancer
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Anal Cancer

Interventions

DrugSynonymsArms
SO-C101Experimental: Part A (SO-C101 Monotherapy)
pembrolizumabExperimental: Part B (SO-C101 combined with pembrolizumab)

Purpose

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Detailed Description

      This study will assess the safety and tolerability of SO-C101 administered as monotherapy and
      in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected
      relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell
      lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin
      squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast
      cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary track cancer,
      hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell
      carcinoma, and anal cancer).
    

Trial Arms

NameTypeDescriptionInterventions
Experimental: Part A (SO-C101 Monotherapy)ExperimentalDrug: SO-C101
  • SO-C101
Experimental: Part B (SO-C101 combined with pembrolizumab)ExperimentalDrug: SO-C101 Drug: pembrolizumab
  • SO-C101
  • pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with selected histologically or cytologically confirmed advanced and/or
             metastatic solid tumors who are refractory to or intolerant of existing therapies
             known to provide clinical benefit for their condition.

          -  ECOG performance score 0-1. Patients with ECOG is 2 to be discussed with the sponsor's
             medical monitor to be agreed for inclusion.

          -  Estimated life expectancy of ≥3 months

          -  Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter)
             for biologic agents including immuno-oncology therapy and 4 weeks from major
             surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy

          -  At least one measurable lesion per iRECIST in a non-irradiated port. If in a
             previously irradiated port, must have demonstrated progression since best response to
             radiation therapy.

          -  Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia)
             or have stable grade 2 neuropathy

          -  Adequate organ system function

          -  Negative serum pregnancy test, if woman of child-bearing potential (WOCBP;
             non-childbearing is defined as greater than one year postmenopausal or surgically
             sterilized).

          -  Accessible tumor tissue available for fresh biopsy

        Exclusion Criteria:

          -  Key exclusion criteria (Part A and B)

               -  Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see
                  list of all exclusion criteria for details)

               -  Known additional malignancy that is progressing and/or requires active treatment.

               -  Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited
                  to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)

               -  History of and current interstitial lung disease or fibrosis and pneumonitis;
                  patients with clinically significant or oxygen requiring COPD or any chronic
                  inflammatory disease (sarcoidosis etc.)

               -  Has received a live vaccine within 30 days of planned start of study therapy (see
                  list of all exclusion criteria for details)

               -  Absolute WBC count ≤ 2.0 ×109/L;

               -  ALC ≤0.5×109/L

               -  Absolute neutrophil count ≤1.0 ×109/L

               -  Platelet count ≤100×109/L

               -  Pregnant or breastfeeding women

               -  Any active autoimmune disease or a documented history of autoimmune disease,
                  poorly controlled asthma, or history of syndrome that required systemic steroids
                  (except the allowed doses) or immunosuppressive medications, except for patients
                  with vitiligo or resolved childhood asthma/atopy (see list of all exclusion
                  criteria for details)

               -  Specific co-morbidities (see list of all exclusion criteria for details)

               -  Is hypersensitive to any of the ingredients of pembrolizumab drug product
                  (KeytrudaTM)

               -  History of solid organ transplantation or hematopoietic stem cell transplantation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part A;Number of Participants With Dose-Limiting Toxicities (DLT):
Time Frame:Through Cycle 1 (a cycle is 21 days]
Safety Issue:
Description:DLT was defined as any of the following AEs occurring in the first cycle of treatment which were attributable to the study drug: •Grade 5 events not clearly related to disease progression or any other causes, grade 3 or higher non-hematologic toxicity regardless of duration, and Hy's law cases will be considered DLTs. .•Grade 3 AST, ALT, or bilirubinemia that lasts >5 days •Grade 4 neutropenia or thrombocytopenia lasting >7 days Febrile neutropenia Grade 3 or higher thrombocytopenia with bleeding Grade 4 immune-related AEs regardless of duration Grade 3 or grade 4 non-infectious pneumonitis regardless of duration Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, that do not downgrade to grade ≤2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids or downgrade to grade 1 or baseline within 14 days Grade 2 pneumonitis that does not resolve to grade 1 within 3 days of care Grade 3 colitis

Secondary Outcome Measures

Measure:Part A PK parameters
Time Frame:assessed in average of 2 months
Safety Issue:
Description:Assess plasma concentration of SO-C101 at various timepoints
Measure:Part A Objective response rate (ORR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:based on investigator review of radiographic images according to iRECIST
Measure:Part A Best overall response (BOR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:BOR by iRECIST
Measure:Part A Duration of Response (DOR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:DOR by iRECIST
Measure:Part A Clinical benefit rate (CBR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:CBR by iRECIST
Measure:Part A Progression-Free Survival (PFS)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:PFS by iRECIST
Measure:Part A Immunogenicity analysis to assess antibodies to SO-C101 in human serum
Time Frame:assessed in average of 4 months
Safety Issue:
Description:to assess antibodies to SO-C101 in human serum
Measure:Part B PK parameters of SO-C101 administered in combination with pemrolizumab
Time Frame:assessed in average of 2 months
Safety Issue:
Description:Assess plasma concentration of SO-C101 (administered in combination with pembrolizumab) at various timepoints
Measure:Part B Objective response rate (ORR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:SO-C101combined with pemrolizumab based on investigator review of radiographic images according to iRECIST
Measure:Part B Best overall response (BOR) of SO-C101
Time Frame:assessed in average of 5 months
Safety Issue:
Description:combined with pemrolizumab by iRECIST
Measure:Part B Duration of Response (DOR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:of SO-C101 combined with pembrolizumab by iRECIST
Measure:Part B Clinical benefit rate (CBR)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:of SO-C101 combined with by iRECIST
Measure:Part B Progression-Free Survival (PFS)
Time Frame:assessed in average of 5 months
Safety Issue:
Description:of SO-C101combined with pemrolizumab by iRECIST
Measure:Immunogenicity analysis to assess antibodies to SO-C101
Time Frame:assessed in average of 4 months
Safety Issue:
Description:SO-C101 in human serum

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sotio a.s.

Trial Keywords

  • thyroid cancer
  • Renal Cell Carcinoma
  • Non Small Cell Lung Cancer
  • Small-cell Lung Cancer
  • Bladder Cancer
  • Melanoma
  • Merkel Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Microsatellite Instability High
  • Triple Negative Breast Cancer
  • Mesothelioma
  • Thymic Cancer
  • Cervical Cancer
  • Biliary Tract Cancer
  • Hepatocellular Carcinoma
  • Ovarian Cancer
  • Gastric Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Anal Cancer

Last Updated

January 15, 2020