A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Conditions

• Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TSR-022 — DRUG
  TSR-022 will be administered.
• Nivolumab — DRUG
  Nivolumab will be administered.
• TSR-042 — DRUG
  TSR-042 will be administered.
• TSR-033 — DRUG
  TSR-033 will be administered.
• Docetaxel — DRUG
  Docetaxel will be administered.
• Pemetrexed — DRUG
  Pemetrexed will be administered.
• Cisplatin — DRUG
  Cisplatin will be administered.
• Carboplatin — DRUG
  Carboplatin will be administered.

Study Details

This is a first-in-human 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 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.

Key Dates

Start date

Jul 8, 2016

Status verified

Oct 2025

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

463 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1a: TSR-022 monotherapy
• Experimental: Part 1b: TSR-022 in combination with nivolumab
• Experimental: Part 1c: TSR-022 in combination with TSR-042
• Experimental: Part 1d: TSR-022 in combination with TSR-042 and TSR-033
• Experimental: Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)
• Experimental: Part 1f: TSR-022 in combination with TSR-042 and Docetaxel
• Experimental: Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin
• Experimental: Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin
• Experimental: Part 2: Cohort A Melanoma-TSR-022 as monotherapy
• Experimental: Part 2: Cohort A Melanoma-TSR-022 with TSR-042
• Experimental: Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy
• Experimental: Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042
• Experimental: Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy
• Experimental: Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042
• Experimental: Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042
• Experimental: Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel
• Experimental: Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042

Primary Outcome Measure

Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) [ Time Frame: Up to 28 days ]

Locations (64)

Find similar trials in Goodyear, AZ

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