Strata PATH™ (Precision Indications for Approved Therapies)

• Status: Not yet recruiting
• Trial end date: 2029-10-21
• Target enrollment: 0
• Participant gender: All

Summary

StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Strata Oncology
• Treatments: Talazoparib

Criteria

To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:

1. Male or female ≥18 years of age.

2. Pathologically confirmed solid tumor

3. Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points

4. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue or historical CGP or RNA profiling test results available for submission

5. Biomarker positive for the defined cohort

6. For individuals with treated or stable brain metastases: No evidence of progression for at least 4 weeks prior to consent

7. Adequate bone marrow, organ function & laboratory parameters as determined by the treating physician

8. Adequate cardiac function: 8.1) Left ventricular ejection fraction (LVEF) ≥ 50%, 8.2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Receiving another anticancer therapy

2. Major surgery within 4 weeks prior to study entry

3. Has received a systemic anticancer therapy within 3 weeks of first study dose

4. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment

5. Ongoing toxicity of CTCAE grade ≥2, other than peripheral neuropathy, related to anticancer therapy that was completed within 4 weeks of consent

6. Ongoing peripheral neuropathy of CTCAE grade ≥3

7. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent

8. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection

9. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder

10. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.