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

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

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Part 1d: TSR-022 in combination with TSR-042 and TSR-033TSR-033-
Part 1f: TSR-022 in combination with TSR-042 and DocetaxelTSR-042-
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinTSR-022-
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinTSR-042-
Part 1b: TSR-022 in combination with nivolumabTSR-022-
Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042TSR-042-
Part 1c: TSR-022 in combination with TSR-042TSR-042-
Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042TSR-042-
Part 2: Cohort A Melanoma-TSR-022 as monotherapyTSR-022-
Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxelTSR-022-
Part 2: Cohort A Melanoma-TSR-022 with TSR-042TSR-042-
Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042TSR-022-
Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapyTSR-022-
Part 1d: TSR-022 in combination with TSR-042 and TSR-033TSR-042-
Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)TSR-042-
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinTSR-042-
Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042TSR-042-
Part 1d: TSR-022 in combination with TSR-042 and TSR-033TSR-022-
Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)TSR-022-
Part 2: Cohort A Melanoma-TSR-022 with TSR-042TSR-022-
Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042TSR-022-
Part 1a: TSR-022 monotherapyTSR-022-
Part 1c: TSR-022 in combination with TSR-042TSR-022-
Part 1f: TSR-022 in combination with TSR-042 and DocetaxelTSR-022-
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinTSR-022-
Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapyTSR-022-
Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042TSR-022-
Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042TSR-022-
Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042TSR-042-
Part 1b: TSR-022 in combination with nivolumabNivolumab-
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinCisplatin-
Part 1f: TSR-022 in combination with TSR-042 and DocetaxelDocetaxel-
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinPemetrexed-
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinCarboplatin-
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinPemetrexed-
Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxelDocetaxel-
Primary Outcome Measures
NameTimeMethod
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 medicationsUp to 2 years
Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1Up to 2 years
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)Up to 28 days
Secondary Outcome Measures
NameTimeMethod
Part 1c: Cmin of TSR-022 in combination with TSR-042Up to 2 years
Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033Up to 2 years
Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033Up to 2 years
Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042Up 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-042Up to 2 years
Part 2 (A, B, C, D): DCR by irRECISTUp to 2 years
Part 2F: Cmin of TSR-022 in combination with TSR-042Up to 2 years
Part 1b: AUC (0-last) of TSR-022 in combination with nivolumabUp to 2 years
Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042Up to 2 years
Part 1b: t1/2 of TSR-022 and in combination with nivolumabUp to 2 years
Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapyUp to 2 years
Part 2 (A, B, C, D): DOR by irRECISTUp to 2 years
Part 2: Progression-free survival (PFS) by RECIST v 1.1Up to 2 years
Part 2: Overall survival (OS)Up to 2 years
Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapyUp to 2 years
Part 1c: t1/2 of TSR-022 in combination with TSR-042Up to 2 years
Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033Up to 2 years
Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to deathUp to 2 years
Part 2: Duration of response (DOR) by RECIST v 1.1Up to 2 years
Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1Up to 2 years
Part 2 (A, B, C, D): PFS by irRECISTUp to 2 years
Parts 1 and 2 (A, B, C, D, E, F): Serum concentration of TSR-022Up to 2 years
Part 1d: Serum concentration of TSR-033Up to 2 years
Part 1 (c, d, e, f, g, h): Serum concentration of TSR-042Up to 2 years
Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033Up to 2 years
Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1Up 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 monotherapyUp to 2 years
Part 1b: Cmin of TSR-022 in combination with nivolumabUp to 2 years
Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumabUp to 2 years
Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033Up to 2 years
Part 2F: AUC (0-inf) of TSR-022 in combination with TSR-042Up to 2 years
Part 2F: AUC (0-last) of TSR-022 in combination with TSR-042Up to 2 years
Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022Up to 2 years
Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022Up to 2 years
Part 1d: Number of participants with ADA to TSR-033Up to 2 years
Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapyUp to 2 years
Part 2F: t1/2 of TSR-022 in combination with TSR-042Up to 2 years
Part 1c: AUCtau of TSR-022 in combination with TSR-042Up to 2 years
Part 2F: AUCtau of TSR-022 in combination with TSR-042Up to 2 years
Part 1 (c, d, e, f, g, h): Number of participants with ADA to TSR-042Up to 2 years
Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapyUp to 2 years
Part 1b: AUCtau of TSR-022 and in combination with nivolumabUp to 2 years
Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042Up to 2 years

Trial Locations

Locations (1)

GSK Investigational Site

🇨🇳

Tainan, Taiwan

GSK Investigational Site
🇨🇳Tainan, Taiwan
US GSK Clinical Trials Call Center
Contact
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
GSKClinicalSupportHD@gsk.com
Edward F McClay
Principal Investigator
Haresh S. Jhangiani
Principal Investigator
Antoni Ribas
Principal Investigator
Peter D Boasberg
Principal Investigator
Paul La Porte
Principal Investigator
Allen L. Cohn
Principal Investigator
Theresa Medina
Principal Investigator
Gerald Falchook
Principal Investigator
Judy S Wang
Principal Investigator
Zeynep Eroglu
Principal Investigator
Jason J Luke
Principal Investigator
Mohammed Milhem
Principal Investigator
Christopher C. Croot
Principal Investigator
John M Wallmark
Principal Investigator
Elizabeth Walsh
Principal Investigator
Benjamin Tan
Principal Investigator
Sanjay Goel
Principal Investigator
Janice Mehnert
Principal Investigator
David Bajor
Principal Investigator
Rex B Mowat
Principal Investigator
Joseph Fiorillo
Principal Investigator
Diwakar Davar
Principal Investigator
Theodore G Gourdin
Principal Investigator
Jeffrey Roger Infante
Principal Investigator
Charles L Cowey
Principal Investigator
Julio Peguero
Principal Investigator
Timothy Yap
Principal Investigator
Donald Richards
Principal Investigator
Habib M. H. Ghaddar
Principal Investigator
Alexander I. Spira
Principal Investigator
Andrea Veatch
Principal Investigator
Bruce Lin
Principal Investigator
Sung Yong Oh
Principal Investigator
Sun Hyo Park
Principal Investigator
Yu Jung kim
Principal Investigator
Yoon Ji Choi
Principal Investigator
Hye Ryun Kim
Principal Investigator
Myung-Ju Ahn
Principal Investigator
Jin-Soo Kim
Principal Investigator
Aitor Azkárate Martínez
Principal Investigator
Eduardo Castanon Alvarez
Principal Investigator
Santiago Viteri Ramírez
Principal Investigator
Paula Cerdà Serdá
Principal Investigator
Enriqueta Felip
Principal Investigator
Maria Elisa Reig Monzón
Principal Investigator
Joaquim Bosch Barrera
Principal Investigator
Jesús Corral Jaime
Principal Investigator
María Jové Casulleras
Principal Investigator
Delvys Rodriguez Abreu
Principal Investigator
Javier De Castro Carpeno
Principal Investigator
Mariano Provencio Pulla
Principal Investigator
Jose Manuel Trigo Pérez
Principal Investigator
Marta López-Brea Piqueras
Principal Investigator
Amparo Sánchez Gastaldo
Principal Investigator
Desamparados Roda Pérez
Principal Investigator
Oscar Juan Vidal
Principal Investigator
Alberto Lue
Principal Investigator
Sheng-Shun Yang
Principal Investigator
Chao-Jung Tsao
Principal Investigator
Chia Jui Yen
Principal Investigator
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