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Olaparib and ASTX727 for BRCA1/2 and HRD-Mutated Cancers

This study is testing a combination of two oral medications, olaparib and ASTX727, for people with advanced solid tumors. You might be able to join if your cancer has specific changes (mutations) in genes like BRCA1, BRCA2, PALB2, ATM, or CHEK2. Researchers want to see how safe this combination is and find the best dose. They will also look at how well the treatment works. This study is currently recruiting a small number of participants (18 people).

Study design
This is a Phase 1/1b interventional study with a 3+3 design, meaning groups of three participants will receive increasing doses. It aims to enroll 18 participants.
What's involved
Participants will take oral medications. The study will assess safety and side effects for up to 2 years, with dose-limiting toxicities measured for up to 1 cycle (28 days).
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured for up to 2 years. Dose-limiting toxicities will be assessed for up to 1 cycle (28 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06177171

Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Varun Monga, MBBS
~13 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:OlaparibASTX727

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with treatment-emergent Adverse Events (AEs) (Phase 1 Only)
Measured over Up to 2 years
+3 more outcomes measured

Conditions

BRCA1 Mutation
BRCA2 Mutation
BRCA Mutation
PALB2 Gene Mutation
Checkpoint Kinase 2 Gene Mutation
ATM Gene Mutation

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NCT06177171

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Varun Monga, MBBS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Testing for DNA repair mutations should occur prior to study consent or enrollment via a CLIA-approved test. 2. Has measurable disease per RECIST 1.1 as assessed by the investigator. Lesions situated in previously irradiated areas are considered measurable if progression has been demonstrated in such lesions. 3. Participants may have received any lines of prior therapy and is refractory or intolerant to therapy approved for their condition or unwilling to receive currently approved therapy. 4. Prior PARP inhibitors are allowed, provided the following two criteria are met:

What this trial measures

  • Proportion of participants with treatment-emergent Adverse Events (AEs) (Phase 1 Only)Up to 2 years

    Adverse events will be classified and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and reported by dose level.

  • Percentages of dose-limiting toxicities (DLTs) (Phase 1 Only)Up to 1 cycle (1 cycle is 28 days)

    A dose-limiting toxicity (DLT) is defined as any of the following events that are considered by the investigator to be at least possibly related to olaparib or ASTX727 and are observed during cycle 1. The percentage of participants with DLTs will be reported.

  • Maximum Tolerated Dose (MTD) (Phase 1 Only)Up to 1 cycle (1 cycle is 28 days)

    The MTD is defined as the highest dose at which no more than one instance of dose-limiting toxicity (DLT) is observed among the first 6 participants treated.

  • Recommended Phase 2 Dose (RP2D) (Phase 1 Only)Up to 1 cycle (1 cycle is 28 days)

    The RP2D for a planned Phase 2 trial will be selected based on the evaluation of dose-limiting toxicities and adverse events measured using CTCAE v5.0.