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TSR-042

Phase 2

Cervical Cancer | Small molecule | Oncology |GSK plc|Last Updated: May 21, 2025

Target and mechanism

Molecular targetPD-1
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

TSR-042 · 1 trial · 2 indications

Phase 2 1
NCT03833479TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiationCervical Cancer
ACTIVE NOT_RECRUITING134 Analytics
PHASE2ACTIVE NOT_RECRUITING
TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation
Cervical CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival
30 months

Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

Secondary Endpoints

Frequency and severity of adverse events (AEs)
30 months
Overall survival (OS)
30 months
Patient reported outcomes (PROs) of health-related quality of life (HRQOL)
30 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
No further treatmentEXPERIMENTALNo further treatment
TSR-042EXPERIMENTALTSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted).

Interventions

NameTypeDescription
No Further TreatmentOTHERNo further treatment
TSR-042DRUGFixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: 1. Signed informed consent before any study-specific procedure 2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 3. Participant must be a female ≥ 18 years of age 4. Life expectancy ≥3 months 5. Participant must have biopsy-confirmed...

Countries:SpainTurkey (Türkiye)
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Competitive Landscape -Cervical Cancer 65 trials

Frequently asked questions about TSR-042

What is TSR-042 used for in cervical cancer?

TSR-042 is an investigational small molecule being studied as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemo-radiation. It is currently in Phase 2 clinical development for this indication, with an active clinical trial evaluating its safety and efficacy in this patient population.

What does TSR-042 target?

TSR-042 targets PD-1, a protein involved in immune checkpoint regulation. By targeting PD-1, TSR-042 is designed to modulate the immune system's response to cancer cells. This mechanism is being investigated in the context of cervical cancer, where it is being studied as a maintenance therapy following chemo-radiation.

Who makes TSR-042?

TSR-042 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate TSR-042 as a potential treatment for cervical cancer, specifically as maintenance therapy for patients with high-risk locally advanced disease.

What phase is TSR-042 in?

TSR-042 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is evaluating TSR-042 as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemo-radiation.

What clinical trials is TSR-042 in?

TSR-042 is being studied in a Phase 2 clinical trial with the identifier NCT03833479. This trial is titled 'TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation' and is actively recruiting participants. The trial is enrolling female patients aged 18 years and older in Spain and Turkey, with a target enrollment of 134 participants.

Is TSR-042 the same as dostarlimab?

No, TSR-042 is not the same as dostarlimab. TSR-042 is a distinct investigational drug being developed by GSK plc for cervical cancer. While both drugs target PD-1, they are separate molecules with different chemical structures and are being evaluated in separate clinical trials.