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A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

NCT05932862 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

XL309

XL309 will be administered orally per assigned schedule.

DRUG

Olaparib

Olaparib will be administered orally per assigned schedule.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2029-01-03
Completion
2029-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932862 on ClinicalTrials.gov