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TSR-022

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment463

FDA Designations

No designations recorded

Clinical trial landscape

TSR-022 · 1 trial · 1 indication

Phase 1 1
NCT02817633A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)Neoplasms
ACTIVE NOT_RECRUITING463 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
NeoplasmsUnlock trial analytics

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 to 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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Frequently asked questions about TSR-022

What is TSR-022 used for?

TSR-022 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for this oncology indication.

What does TSR-022 target?

TSR-022 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its potential role in treating neoplasms, though the exact mechanism of action is not publicly available.

Who makes TSR-022?

TSR-022 is being developed by GSK plc, a global biopharmaceutical company. GSK is listed on the stock exchange under the ticker symbol GSK.

What phase is TSR-022 in?

TSR-022 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied in an active clinical trial for advanced solid tumors.

What clinical trials is TSR-022 in?

TSR-022 is being studied in a Phase 1 clinical trial with the identifier NCT02817633, known as the AMBER study. This trial is investigating TSR-022 in participants with advanced solid tumors and is active but not recruiting. The trial has enrolled 463 participants across the United States, South Korea, and Spain.

Is TSR-022 the same as any other drug?

TSR-022 is a unique investigational drug candidate. No alternative names for TSR-022 have been disclosed, and it is not known to be the same as any other approved or investigational medication.