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Clinical Trial 19302

Cancer Type: Multiple
Interventions:Not Applicable; TSR-033; TSR-042

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Solmaz Sahebjam

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with Advanced Solid Tumors

Summary

This purpose of this study is to evaluate the anti-LAG-3 antibody of TSR-033 alone and in combination with anti-PD-1. The study will be conducted in 2 parts, with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with an anti-PD-1 antibody (Part 1c). Part 2 of the study will evaluate the anti-tumor activity of TSR-033 in combination with an anti-PD-1 in participants.

Objective

Primary: Part 1: Dose Escalation Cohorts: - To define the recommended Phase 2 dose (RP2D) and schedule of TSR-033 as monotherapy and in combination with TSR-042 (anti-PD-1) - To evaluate the safety and tolerability of TSR-033 as monotherapy and in combination with TSR-042 in patients with advanced solid tumors Part 2: Dose Expansion Cohorts: - To evaluate the anti-tumor activity of TSR-033 in combination with TSR-042 in patients with solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - To confirm the RP2D and schedule TSR-033 in combination with TSR-042 Secondary: In Part 1 and Part 2, unless otherwise specified: - To characterize the PK of TSR-033 when given alone and in combination with TSR-042 - To characterize the PK of TSR-042 when given in combination with TSR-033 - To evaluate the immunogenicity of TSR-033 - To evaluate additional measures of clinical benefit, including − ORR by RECIST v 1.1 for patients in Part 1 − Duration of response by RECIST v 1.1 − Disease control rate by RECIST v 1.1 − Progression-free survival by RECIST v 1.1 − Overall survival Exploratory: - To characterize the PDy profile of TSR-033 - To evaluate the immunogenicity of TSR-042 in (Part 1c and Part 2) - To identify a biomarker-based patient population that would derive clinical benefit from TSR-033 treatment based on the pre-treatment profile of TILs, tumor characteristics, and/or circulating biomarkers. - To explore changes in biomarkers (eg, immune cells, cytokines or chemokines in the tumor and circulating biomarkers in the blood following treatment with TSR-033 and correlate with clinical benefit - To explore additional clinical efficacy outcomes by irRECIST

Inclusion Criteria

  • Patients with advanced (unresectable) or metastatic solid tumor and have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
  • 18 years of age or older
  • Participants must have tumor tissue available.
  • Females must have a negative serum or urine pregnancy test or be of non-childbearing potential.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 and adequate organ function.
  • Key Inclusion Criteria Part 2: Must have not been previously treated with an anti - LAG - 3, anti - PD - 1, anti - PD - L1, or anti - PD - L2 antibody.
  • Additional criteria may apply

  • Exclusion Criteria

  • Known uncontrolled central nervous system metastases and - or carcinomatous meningitis.
  • History of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C.
  • Participated in another investigational study (drug or device) within 4 weeks of first dose.
  • Received prior anticancer therapy within 21 days of first dose.
  • Not recovered from Adverse Events (AEs) and - or complications from major surgery prior to first dose.
  • Vaccine within 7 days of planned start of study treatment.
  • Additional criteria may apply