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TSR-022

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Oct 28, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment463
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02817633A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)PHASE1 ACTIVE NOT_RECRUITING 463Jul 8, 2016Mar 1, 2027Oct 28, 202589 United States, South Korea +1
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Study Endpoints
Primary Endpoints
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)
Up to 28 days
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 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: 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
Secondary Endpoints
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 2: Duration of response (DOR) by RECIST v 1.1
Up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1a: TSR-022 monotherapyEXPERIMENTAL -
Part 1b: TSR-022 in combination with nivolumabEXPERIMENTAL -
Part 1c: TSR-022 in combination with TSR-042EXPERIMENTAL -
Part 1d: TSR-022 in combination with TSR-042 and TSR-033EXPERIMENTAL -
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 DocetaxelEXPERIMENTAL -
Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinEXPERIMENTAL -
Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinEXPERIMENTAL -
Part 2: Cohort A Melanoma-TSR-022 as monotherapyEXPERIMENTAL -
Part 2: Cohort A Melanoma-TSR-022 with TSR-042EXPERIMENTAL -
Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapyEXPERIMENTAL -
Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042EXPERIMENTAL -
Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapyEXPERIMENTAL -
Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042EXPERIMENTAL -
Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042EXPERIMENTAL -
Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxelEXPERIMENTAL -
Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042EXPERIMENTAL -
Interventions
NameTypeDescription
TSR-022DRUGTSR-022 will be administered.
NivolumabDRUGNivolumab will be administered.
TSR-042DRUGTSR-042 will be administered.
TSR-033DRUGTSR-033 will be administered.
DocetaxelDRUGDocetaxel will be administered.
PemetrexedDRUGPemetrexed will be administered.
CisplatinDRUGCisplatin will be administered.
CarboplatinDRUGCarboplatin will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites89

Inclusion Criteria * Participant is at least 18 years of age. * Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential. * Participant has an ECOG per...

Countries:United StatesSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT02817633primaryCompletionDate: changed
LOWMay 24, 2026NCT02817633studyFirstPostDate: changed