Clinical Trials Using Anti-TIM-3 Monoclonal Antibody TSR-022
Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-TIM-3 Monoclonal Antibody TSR-022. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts: with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 as a single agent (Part 1a); in combination with anti-programmed cell death protein-1 (PD-1) antibody, nivolumab (Part 1b); in combination with anti-PD-1 antibody, TSR-042 (Part 1c); in combination with TSR-042 and anti-lymphocyte-activation gene 3 (LAG-3) antibody, TSR-033 (Part 1d); in combination with TSR-042 in participants not previously treated with programmed death-ligand 1 [PD-(L)1] (Part 1e) and in combination with docetaxel (Part 1f). Part 2 of the study will evaluate the antitumor activity of TSR-022, both as monotherapy and in combination with TSR-042 in participants with pre-specified tumor types.
Location: 14 locations
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab, chemotherapy or other immune therapies. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
Location: 6 locations
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC)
This study will compare the clinical activity of novel regimens (in combination or as single agents) to standard of care in participants with relapsed / refractory advanced NSCLC. The study will be conducted in two parts; Part 1 is an optional, non-randomized part based on safety and pharmacokinetics / pharmacodynamics (PK / PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II study comparing the efficacy and safety of these novel regimens with SoC.
Location: 5 locations
Dostarlimab Alone or in Combination with Cobolimab for the Treatment of Resectable Stage III or IV Melanoma
This phase II trial investigates how well dostarlimab alone or in combination with cobolimab works in treating patients with stage III or stage IV melanoma that can be removed by surgery (resectable). Dostarlimab is a PD-1 inhibitor and cobolimab is a TIM-3 inhibitor. Dostarlimab works by encouraging the body’s own immune system to attack the cancer cells. The immune system is a network of cells, tissues, and organs that work together to defend the body against diseases. Cobolimab may improve upon the benefit of dostarlimab. Giving dostarlimab in combination with cobolimab may work better to treat stage III or IV melanoma compared to dostarlimab alone.
Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania