Clinical Trials /

A Study of PSB205 in Subjects With Advanced Solid Tumors

NCT03986606

Description:

This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.

Related Conditions:
  • Colon Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of PSB205 in Subjects With Advanced Solid Tumors
  • Official Title: A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients With Relapsed/Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: PSB205-001
  • NCT ID: NCT03986606

Conditions

  • Neoplasm Malignant

Interventions

DrugSynonymsArms
PSB205Open-label Dose Escalation and Expansion Study of PSB205

Purpose

This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.

Trial Arms

NameTypeDescriptionInterventions
Open-label Dose Escalation and Expansion Study of PSB205ExperimentalPart 1 (Dose escalation): PSB205 will be administered in sequential cohorts of 3 to 6 subjects each receiving 1 of 5 doses of PSB205 on day 1 of every 21-day cycle (3 weeks) via IV infusion using a standard 3+3 dose escalation design. Dose escalation will continue until an MTD is reached. Part 2 (Dose Expansion): The clinical anti-tumor effects of PSB205 will be tested at the recommended Phase 2 dose (RP2D) determined during the dose-escalation phase in subjects from three different solid tumor cohorts.
  • PSB205

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female subjects aged 18 years or older.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Inclusion of subjects
             with an ECOG performance status of 2 should be discussed and is at the discretion of
             the sponsor's medical monitor and the investigator.

          -  Life expectancy of ≥3 months.

          -  Female subjects who are not pregnant or breastfeeding, 1 year postmenopausal, or
             surgically sterile and males even if surgically sterilized that Agree to practice
             effective barrier contraception during the entire study treatment period and through
             180 days after the last dose of study drug, or agree to practice true abstinence, when
             this is in line with the preferred and usual lifestyle of the subject.

          -  Suitable venous access for the study-required blood sampling, including PK and
             Pharmacodynamic sampling.

               1. To be enrolled in Part 1 (Dose escalation), subjects must have:

                    1. Histologically confirmed diagnosis of advanced solid tumor and preferably
                       radiographically or clinically measurable disease. Subjects with
                       non-measurable, evaluable disease are permitted

                    2. One or more prior lines of therapy . No curative options and progressed on
                       or following standard of care therapy (SOC).

               2. To be enrolled in Part 2 (Dose expansion), subjects must have:

                    1. Histologically confirmed diagnosis of advanced solid tumor of the following
                       types, and radiographically or clinically measurable disease, one or more
                       prior lines of therapy, no curative options and progressed on or following
                       SOC.

                    2. Squamous cell carcinomas- squamous non-small cell lung cancer (NSCLC) or
                       squamous cell carcinoma of the head and neck (HNSCC)

                    3. Locally advanced or metastatic gastric or gastroesophageal carcinoma

                    4. Advanced or metastatic renal cell Carcinoma (clear cell, papillary, other)

                    5. MSI-high colon carcinoma

                    6. Small cell lung cancer

                    7. Advanced urothelial cancer

                    8. Metastatic melanoma I. Advanced soft-tissue or bone sarcoma

        Exclusion Criteria:

          1. Active or prior documented autoimmune disease (including inflammatory bowel disease,
             celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood
             atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis
             not requiring systemic treatment (within the past 2 years) are not excluded.

          2. Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.

          3. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord
             compression. Subjects previously treated central nervous system metastases that are
             radiographically and neurologically stable for at least 6 weeks and do not require
             corticosteroids (of any dose) for symptomatic management for at least 14 days prior to
             first dose of study drug are permitted to enroll.

          4. Hypertension unable to be controlled to ≤Grade 2 with medication.

          5. Any condition requiring systemic treatment with corticosteroids (>10 mg daily
             prednisone equivalents) or other immunosuppressive medications within 14 days before
             first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled
             steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are
             permitted.

          6. Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.

          7. Systemic anti-cancer treatment (including investigational agents). This includes
             radiotherapy <2 weeks before the first dose of study drug, ≤4 weeks for antibody-based
             therapy including unconjugated antibody, antibody-drug conjugate, and bi-specific T
             cell engaging agents; (≤8 weeks for cell-based therapy or anti-tumor vaccine) or have
             not recovered from acute toxic effects from prior chemotherapy and radiotherapy.

          8. Major surgery within 14 days before the first dose of study drug and not recovered
             fully from any complications from surgery.

          9. Systemic infection requiring IV antibiotic therapy or other serious infection within
             14 days before the first dose of study drug.

         10. Subjects with a history of organ transplant.

         11. Hepatitis B surface antigen-positive or known or suspected active hepatitis C
             infection.

         12. Known human immunodeficiency virus (HIV) positive.

         13. Subjects with any of the following cardiovascular conditions are excluded:

               1. Acute myocardial infarction within 6 months before first dose of study drug.

               2. Current or history of New York Heart Association Class III or IV heart failure.

               3. Evidence of current uncontrolled cardiovascular conditions including cardiac
                  arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of
                  acute ischemia or active conduction system abnormalities.

         14. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or
             pneumonitis requiring treatment with steroids or other immunosuppressive medications.

         15. Subject has a history of alcoholism or drug abuse within the past 6 months.

         16. Vaccinations within 4 weeks of first dose of study drug.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability
Time Frame:28 days
Safety Issue:
Description:Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

Trial Keywords

  • neoplasm
  • checkpoint inhibitor
  • combination
  • immunotherapy

Last Updated

November 25, 2020