At a glance
ClinicalIndex Comparison Record- ✓Dose escalation: any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, relapsed after or progressing despite conventional treatment
- ✓Expansion: metastatic CRC, platinum-resistant/intolerant HGSOC, advanced NSCLC, mCRPC, HNSCC, or squamous cell carcinoma of the anus, with no other conventional therapy considered appropriate
- ✓Life expectancy of at least 12 weeks
- ✓WHO performance status 0-1
- ✕Radiotherapy within 6 weeks, endocrine therapy within 4 weeks, chemotherapy within 4 weeks, or immunotherapy within 6 weeks
- ✕Nitrosoureas or Mitomycin C within 6 weeks, or other investigational drug within 4 weeks
- ✕Any prior Chk1 inhibitor or ATR inhibitor within 6 months
- ✕Other malignancy within past 2 years, except adequately treated tumors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Trial of SRA737 (a Chk1 Inhibitor) Administered Orally in Subjects With Advanced Cancer
In Brief
A Phase 2 clinical trial evaluating SRA737 for Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL). Completed, enrolled 107 participants across 15 sites.
Detailed Summary
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose and schedule of SRA737; and to evaluate the efficacy of SRA737 in prospectively-selected subjects with genetically-defined tumors that harbor genomic alterations linked to increased replication stress and that are hypothesized to be more sensitive to checkpoint kinase 1 (Chk1) inhibition via synthetic lethality. Specific cancer indications that frequently harbor these genetic mutations will be studied.
Study Details
Timeline
Interventions
SRA737 will be administered orally on each day of a 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Subjects can continue taking SRA737 if they are receiving clinical benefit and able to safely take the drug and follow the requirements of the study.