A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
Phase 1
Recruiting
- Conditions
- Neoplasms
- Interventions
- 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
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 F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 TSR-042 - Part 1c: TSR-022 in combination 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 1d: TSR-022 in combination with TSR-042 and TSR-033 TSR-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 cisplatin TSR-042 - Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-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 2: Cohort A Melanoma-TSR-022 with TSR-042 TSR-022 - 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 1f: TSR-022 in combination with TSR-042 and Docetaxel TSR-022 - 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 D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 TSR-022 - Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 TSR-042 - 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 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 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 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
GSK Investigational Site🇨🇳Tainan, TaiwanUS GSK Clinical Trials Call CenterContact877-379-3718GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call CentreContact+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.comEdward F McClayPrincipal InvestigatorHaresh S. JhangianiPrincipal InvestigatorAntoni RibasPrincipal InvestigatorPeter D BoasbergPrincipal InvestigatorPaul La PortePrincipal InvestigatorAllen L. CohnPrincipal InvestigatorTheresa MedinaPrincipal InvestigatorGerald FalchookPrincipal InvestigatorJudy S WangPrincipal InvestigatorZeynep ErogluPrincipal InvestigatorJason J LukePrincipal InvestigatorMohammed MilhemPrincipal InvestigatorChristopher C. CrootPrincipal InvestigatorJohn M WallmarkPrincipal InvestigatorElizabeth WalshPrincipal InvestigatorBenjamin TanPrincipal InvestigatorSanjay GoelPrincipal InvestigatorJanice MehnertPrincipal InvestigatorDavid BajorPrincipal InvestigatorRex B MowatPrincipal InvestigatorJoseph FiorilloPrincipal InvestigatorDiwakar DavarPrincipal InvestigatorTheodore G GourdinPrincipal InvestigatorJeffrey Roger InfantePrincipal InvestigatorCharles L CoweyPrincipal InvestigatorJulio PegueroPrincipal InvestigatorTimothy YapPrincipal InvestigatorDonald RichardsPrincipal InvestigatorHabib M. H. GhaddarPrincipal InvestigatorAlexander I. SpiraPrincipal InvestigatorAndrea VeatchPrincipal InvestigatorBruce LinPrincipal InvestigatorSung Yong OhPrincipal InvestigatorSun Hyo ParkPrincipal InvestigatorYu Jung kimPrincipal InvestigatorYoon Ji ChoiPrincipal InvestigatorHye Ryun KimPrincipal InvestigatorMyung-Ju AhnPrincipal InvestigatorJin-Soo KimPrincipal InvestigatorAitor Azkárate MartínezPrincipal InvestigatorEduardo Castanon AlvarezPrincipal InvestigatorSantiago Viteri RamírezPrincipal InvestigatorPaula Cerdà SerdáPrincipal InvestigatorEnriqueta FelipPrincipal InvestigatorMaria Elisa Reig MonzónPrincipal InvestigatorJoaquim Bosch BarreraPrincipal InvestigatorJesús Corral JaimePrincipal InvestigatorMaría Jové CasullerasPrincipal InvestigatorDelvys Rodriguez AbreuPrincipal InvestigatorJavier De Castro CarpenoPrincipal InvestigatorMariano Provencio PullaPrincipal InvestigatorJose Manuel Trigo PérezPrincipal InvestigatorMarta López-Brea PiquerasPrincipal InvestigatorAmparo Sánchez GastaldoPrincipal InvestigatorDesamparados Roda PérezPrincipal InvestigatorOscar Juan VidalPrincipal InvestigatorAlberto LuePrincipal InvestigatorSheng-Shun YangPrincipal InvestigatorChao-Jung TsaoPrincipal InvestigatorChia Jui YenPrincipal Investigator