A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
Phase 1
Recruiting
- Conditions
- Neoplasms
- Interventions
- Drug: TSR-022Drug: TSR-042Drug: NivolumabDrug: TSR-033Drug: DocetaxelDrug: PemetrexedDrug: CisplatinDrug: Carboplatin
- Registration Number
- NCT02817633
- Lead Sponsor
- Tesaro, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 447
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1d: TSR-022 in combination with TSR-042 and TSR-033 TSR-033 - Part 1f: TSR-022 in combination with TSR-042 and Docetaxel TSR-042 - Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin TSR-022 - Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin TSR-042 - Part 1b: TSR-022 in combination with nivolumab TSR-022 - Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 TSR-022 - Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 TSR-042 - Part 1d: TSR-022 in combination with TSR-042 and TSR-033 TSR-022 - Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) TSR-022 - Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) TSR-042 - Part 2: Cohort A Melanoma-TSR-022 with TSR-042 TSR-022 - Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 TSR-042 - Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 TSR-022 - Part 1a: TSR-022 monotherapy TSR-022 - Part 1c: TSR-022 in combination with TSR-042 TSR-022 - Part 1c: TSR-022 in combination with TSR-042 TSR-042 - Part 1d: TSR-022 in combination with TSR-042 and TSR-033 TSR-042 - Part 1f: TSR-022 in combination with TSR-042 and Docetaxel TSR-022 - Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin TSR-042 - Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin TSR-022 - Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy TSR-022 - Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 TSR-022 - Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 TSR-042 - Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 TSR-042 - Part 2: Cohort A Melanoma-TSR-022 as monotherapy TSR-022 - Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel TSR-022 - Part 2: Cohort A Melanoma-TSR-022 with TSR-042 TSR-042 - Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 TSR-022 - Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy TSR-022 - Part 1b: TSR-022 in combination with nivolumab Nivolumab - Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin Cisplatin - Part 1f: TSR-022 in combination with TSR-042 and Docetaxel Docetaxel - Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin Pemetrexed - Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin Carboplatin - Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin Pemetrexed - Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel Docetaxel -
- Primary Outcome Measures
Name Time Method Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs) Up to 2 years Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs) Up to 42 days Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs) Up to 21 days Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications Up to 2 years Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 Up to 2 years Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) Up to 28 days
- Secondary Outcome Measures
Name Time Method Part 1c: Cmin of TSR-022 in combination with TSR-042 Up to 2 years Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 Up to 2 years Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP) Baseline, and up to 2 years Part 2 (A, B, C, D, F): Serum concentration of TSR-042 Up to 2 years Part 2 (A, B, C, D): DCR by irRECIST Up to 2 years Part 2F: Cmin of TSR-022 in combination with TSR-042 Up to 2 years Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab Up to 2 years Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 Up to 2 years Part 1b: t1/2 of TSR-022 and in combination with nivolumab Up to 2 years Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy Up to 2 years Part 2 (A, B, C, D): DOR by irRECIST Up to 2 years Part 2: Progression-free survival (PFS) by RECIST v 1.1 Up to 2 years Part 2: Overall survival (OS) Up to 2 years Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy Up to 2 years Part 1c: t1/2 of TSR-022 in combination with TSR-042 Up to 2 years Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033 Up to 2 years Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death Up to 2 years Part 2: Duration of response (DOR) by RECIST v 1.1 Up to 2 years Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 Up to 2 years Part 2 (A, B, C, D): PFS by irRECIST Up to 2 years Parts 1 and 2 (A, B, C, D, E, F): Serum concentration of TSR-022 Up to 2 years Part 1d: Serum concentration of TSR-033 Up to 2 years Part 1 (c, d, e, f, g, h): Serum concentration of TSR-042 Up to 2 years Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 Up to 2 years Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1 Up to 2 years Part 2 (A, B, C, D): ORR by Immune related RECIST (irRECIST) Up to 2 years Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy Up to 2 years Part 1b: Cmin of TSR-022 in combination with nivolumab Up to 2 years Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab Up to 2 years Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 Up to 2 years Part 2F: AUC (0-inf) of TSR-022 in combination with TSR-042 Up to 2 years Part 2F: AUC (0-last) of TSR-022 in combination with TSR-042 Up to 2 years Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022 Up to 2 years Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022 Up to 2 years Part 1d: Number of participants with ADA to TSR-033 Up to 2 years Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy Up to 2 years Part 2F: t1/2 of TSR-022 in combination with TSR-042 Up to 2 years Part 1c: AUCtau of TSR-022 in combination with TSR-042 Up to 2 years Part 2F: AUCtau of TSR-022 in combination with TSR-042 Up to 2 years Part 1 (c, d, e, f, g, h): Number of participants with ADA to TSR-042 Up to 2 years Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 Up to 2 years Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033 Up to 2 years Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy Up to 2 years Part 1b: AUCtau of TSR-022 and in combination with nivolumab Up to 2 years Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042 Up to 2 years
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇳Tainan, Taiwan