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 120 genetically-defined patients into indication specific cohorts, including advanced or metastatic:
- castration-resistant prostate cancer (mCRPC);
- high grade serous ovarian cancer (HGSOC);
- CCNE1-driven HGSOC:
- 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. Significant progress has been made in the LDG Combo Dose Escalation Phase 1, and the combination regimen has been well-tolerated.
- 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 targeting enrollment of 80 genetically-selected patients across four indications, including advanced or metastatic:
- urothelial carcinoma;
- small cell lung cancer (SCLC);
- soft tissue sarcoma; and
- cervical/anogenital cancer.