OncoMatch/Clinical Trials/NCT05932862
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Is NCT05932862 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including XL309 and Olaparib for advanced solid tumor.
Treatment: XL309 · Olaparib — This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRCA1 deleterious or suspected deleterious alteration
deleterious or suspected deleterious breast cancer gene (BRCA)1/2 alteration
Required: BRCA2 deleterious or suspected deleterious alteration
deleterious or suspected deleterious breast cancer gene (BRCA)1/2 alteration
Disease stage
Required: Stage III, IV
Metastatic disease required
locally advanced/metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
Participants whose tumor progressed on, or who were intolerant to standard therapy, have a disease for which no therapy exists or are not a candidate for these therapies
Cannot have received: ubiquitin specific peptidase 1 (USP1) inhibitor
Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor
Lab requirements
Blood counts
Kidney function
Liver function
Adequate bone marrow and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Exelixis Clinical Site #12 · Fountain Valley, California
- Exelixis Clinical Site #15 · Jacksonville, Florida
- Exelixis Clinical Site #8 · Orlando, Florida
- Exelixis Clinical Site #16 · Tampa, Florida
- Exelixis Clinical Site #14 · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05932862 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ubiquitin specific peptidase 1 (USP1) inhibitor disqualifies patients from enrollment.
Does this trial require BRCA1?
Yes, BRCA1 deleterious or suspected deleterious alteration is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 deleterious or suspected deleterious alteration is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify