SRA737-01 Phase 1/2 Monotherapy Trial
For more information, visit ClinicalTrials.gov, identifier: NCT02797964
This clinical study is evaluating SRA737 monotherapy in subjects with genetically-defined tumors that harbor genomic alterations linked to increased replication stress, and therefore are hypothesized to be more sensitive to Chk1 inhibition. The multicenter, open-label Phase 1/2 trial consists of two phases, a safety-oriented Dose Escalation Phase 1 in unselected ‘all-comer’ patients and an efficacy-oriented Cohort Expansion Phase 2 in patients with genetically-defined tumors that harbor genomic alterations linked to increased replication stress and hypothesized to be more sensitive to Chk1 inhibition.
The Dose Escalation Phase 1 is complete, having proceeded through multiple dose levels, and SRA737 has been well-tolerated from 20 mg QD to 1000 mg QD as monotherapy.
The Cohort Expansion Phase 2 portion of the trial is targeting enrollment of 65 genetically-defined patients with CCNE1-driven and non-CCNE1-driven high grade serous ovarian cancer (HGSOC). This trial is also enrolling patients into several additional indication specific cohorts, including advanced or metastatic:
- castration-resistant prostate cancer (mCRPC);
- non-small cell lung cancer (NSCLC);
- head and neck squamous cell carcinoma (HNSCC) or squamous cell carcinoma of the anus (SCCA); and
- colorectal cancer (mCRC).
SRA737-02 Phase 1/2 Low Dose Gemcitabine Combination Trial
For more information, visit ClinicalTrials.gov, identifier: NCT02797977
This clinical trial consists of three phases:
- A Standard Dose Triplet Combo Dose Escalation Phase 1 evaluating a combination of SRA737 with standard dose gemcitabine and cisplatin in patients with solid tumors. This phase has concluded.
- A Low Dose Gemcitabine (LDG) Combo Dose Escalation Phase 1 evaluating safety in ‘all-comer’ non-selected patients, where cohorts of 3 to 6 patients are being administered escalating doses of SRA737 on an intermittent schedule in addition to low dose gemcitabine (5-10% of the standard gemcitabine dose) until the combination maximum tolerated dose (MTD) is reached.
- A Low Dose Gemcitabine Combo Cohort Expansion Phase 2, that will explore the preliminary efficacy of SRA737 plus low dose gemcitabine in prospectively enrolled genetically-defined patients with tumors that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality. This phase is planning to target enrollment of 80 genetically-selected patients across four indications, including advanced or metastatic:
- high grade serous ovarian cancer (HGSOC);
- small cell lung cancer (SCLC);
- soft tissue sarcoma; and
- cervical/anogenital cancer.