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SRA737, gemcitabine, cisplatin

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |GSK plc|Last Updated: Jun 22, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

SRA737, gemcitabine, cisplatin · 1 trial · 1 indication

Phase 1 1
NCT02797977A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer SubjectsAdvanced Solid Tumors
COMPLETED153 Analytics
PHASE1COMPLETED
A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects with adverse events as assessed by CTCAE4.03
Up to 30 days after last dose of SRA737
Maximum tolerated dose of SRA737 administered in combination with gemcitabine
Cycle 1 (28 days) in the Dose Escalation Phase
Recommended Phase 2 dose of SRA737 in combination with gemcitabine.
Up to 30 days after last dose of SRA737
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard-Dose Triplet CombinationEXPERIMENTALSRA737 will be administered orally on Days 2, 3, 9, and 10 of each 21-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Gemcitabine will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin will be administered on Day 1 of each 21-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study.
Low-Dose Gemcitabine CombinationEXPERIMENTALSRA737 will be administered orally on Days 2, 3, 9, 10, 16, and 17 of each 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle. Gemcitabine will be administered intravenously on Days 1, 8, and 15 of each 28-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study.

Interventions

NameTypeDescription
SRA737, gemcitabine, cisplatinDRUG -
SRA737, gemcitabineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Key Inclusion Criteria: 1. For Dose Escalation: subjects with locally advanced or metastatic, histologically or cytologically proven solid tumor, relapsed after or progressing despite conventional treatment 2. Life expectancy of at least 12 weeks 3. World Health Organization (WHO) performance statu...

Countries:SpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about SRA737, gemcitabine, cisplatin

What is SRA737 used for?

SRA737 is an investigational small molecule being studied for the treatment of advanced solid tumors and advanced solid tumors or non-Hodgkin's lymphoma (NHL). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes SRA737?

SRA737 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials for advanced cancer indications.

What phase is SRA737 in?

SRA737 is in Phase 1 clinical development. It has completed two Phase 1 trials, and it remains an investigational drug, meaning it has not received regulatory approval and is still being evaluated for safety and efficacy.

What clinical trials is SRA737 in?

SRA737 has been studied in two completed Phase 1 trials. The first, NCT02797964, evaluated SRA737 alone in subjects with advanced solid tumors or non-Hodgkin's lymphoma. The second, NCT02797977, tested SRA737 in combination with gemcitabine and cisplatin or gemcitabine alone in advanced cancer subjects.

How does SRA737 work?

SRA737 is a small molecule designed to target specific pathways involved in cancer cell growth. As an investigational oncology drug, it is being studied for its potential to treat advanced solid tumors and non-Hodgkin's lymphoma by interfering with cancer cell mechanisms.