Advanced Solid TumorPhase 1POLARNCT06560632

Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors

A Phase 1 study testing RP-3467 at assigned dose and schedule and Olaparib 200-300 mg BID, daily in people with Advanced Solid Tumor, run by Repare Therapeutics at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: RP-3467 at assigned dose and schedule and Olaparib 200-300 mg BID, daily
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 5 sitesUnited States
Study dates: 17 Sep 2024to 28 Oct 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female participants ≥18 years of age at the time of signing the informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:
locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or
metastatic breast cancer, or
metastatic castration-resistant prostate cancer (mCRPC), or

Show all 13Show fewer

pancreatic adenocarcinoma
Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease [per RECIST and or PSA/CA-125])
Next generation sequencing (NGS) report demonstrating eligible tumor biomarker
Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied
Acceptable organ function at Screening
Acceptable hematologic function at Screening
Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment

Who cannot join

History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
Uncontrolled, symptomatic brain metastases.
Presence of other known active invasive cancers
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Prior therapy with a Polθ inhibitor other than RP-3467

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

# 1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
# 1008, Columbia University
New York, New York, 10032
# 1004, Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
# 1025, The University of California
San Francisco, California, 94158
# 1011, The Washington University
St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (POLAR Trial)

Read the detailed description

This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to:

Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination
Characterize the PK profile of RP-3467 alone and in combination with olaparib

Conditions: Advanced Solid Tumor
Being tested: RP-3467 at assigned dose and schedule, Olaparib 200-300 mg BID, daily

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RP-3467 at assigned dose and scheduleDrug
Eligible participants will be treated with escalating doses of RP-3467 monotherapy
Olaparib 200-300 mg BID, dailyDrug
Also called RP-3467 at assigned dose and schedule, Lynparza
Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib

Study groups in NCT06560632
Study group	Role	What they receive
Arm 1: RP-3467 monotherapy	Experimental	Eligible participants will be treated with escalating doses of RP-3467 monotherapy Receives: Drug: RP-3467 at assigned dose and schedule
Arm2: RP-3467 + Olaparib combination	Experimental	Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib Receives: Drug: RP-3467 at assigned dose and schedule; Drug: Olaparib 200-300 mg BID, daily

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment
The assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.
Measured: Start of treatment to 30 days post last dose, up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202428 Oct 2025

First posted19 Aug 2024
Study start17 Sep 2024
Primary completion28 Oct 2025
Study completion28 Oct 2025

Why it stopped: Sponsor decided to terminate study early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560632
Sponsor's protocol ID: RP-3467-01
Acronym: POLAR
Status last verified: Dec 2025
First submitted: 9 Aug 2024
Last updated: 16 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (POLAR Trial)
ClinicalTrials.gov ID: NCT06560632
Acronym / sponsor ID: POLAR / RP-3467-01
Conditions: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decided to terminate study early
Enrolment: 26 participants (actual)
Lead sponsor: Repare TherapeuticsIndustry (pharma, biotech, devices)
Study start: 17 Sep 2024 (actual)
Primary completion: 28 Oct 2025 (actual)
Study completion: 28 Oct 2025 (actual)
First posted: 19 Aug 2024 (actual)
Results: Posted 16 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to:

Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination
Characterize the PK profile of RP-3467 alone and in combination with olaparib

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: RP-3467 monotherapy	Experimental	Drug: RP-3467 at assigned dose and scheduleEligible participants will be treated with escalating doses of RP-3467 monotherapy
Arm2: RP-3467 + Olaparib combination	Experimental	Drug: RP-3467 at assigned dose and schedule, Drug: Olaparib 200-300 mg BID, dailyEligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or female participants ≥18 years of age at the time of signing the informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:
Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease [per RECIST and or PSA/CA-125])
Next generation sequencing (NGS) report demonstrating eligible tumor biomarker

Key exclusion criteria (5 listed)

History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
Uncontrolled, symptomatic brain metastases.
Presence of other known active invasive cancers
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Prior therapy with a Polθ inhibitor other than RP-3467

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RP-3467 at assigned dose and scheduleEligible participants will be treated with escalating doses of RP-3467 monotherapy	Drug	Arm 1: RP-3467 monotherapy, Arm2: RP-3467 + Olaparib combination
Olaparib 200-300 mg BID, dailyAlso: RP-3467 at assigned dose and schedule, LynparzaEligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib	Drug	Arm2: RP-3467 + Olaparib combination

Primary outcome

The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment
Time frame: Start of treatment to 30 days post last dose, up to 13 months
The assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.

Results and safety

Results posted to the registry on 16 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: 160 mg QD RP-3467	1	0
Arm 1: 320 mg QD RP-3467	3	0
Arm 1: 640 mg QD RP-3467	4	0
Arm 2: 80 mg QD RP-3467 + 200 mg BID Olaparib	3	0
Arm 2: 80 mg QD RP-3467 + 300 mg BID Olaparib	2	0
Arm 2: 40 mg QD RP-3467 + 300 mg BID Olaparib	13	0

Primary outcome: The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment

Time frame: Start of treatment to 30 days post last dose, up to 13 months. Count of participants. Unit: Participants

Measure	Arm 1: 160 mg QD RP-3467 n = 1	Arm 1: 320 mg QD RP-3467 n = 3	Arm 1: 640 mg QD RP-3467 n = 3	Arm 2: 80 mg QD RP-3467 + 200 mg BID Olaparib n = 3	Arm 2: 80 mg QD RP-3467 + 300 mg BID Olaparib n = 1	Arm 2: 40 mg QD RP-3467 + 300 mg BID Olaparib n = 13
Value	0	0	0	0	0	1

Adverse events

Time frame: Start of treatment to 30 days post last dose, up to 13 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: 160 mg RP-3467 QD	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Arm 1: 320 mg RP-3467 QD	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Arm 1: 640 mg RP-3467 QD	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Arm 2: 80 mg RP-3467 QD+200 mg BID Ola	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Arm 2: 80 mg RP-3467 QD+300 mg BID Ola	1 of 2 (50%)	1 of 2 (50%)	1 of 2
Arm 2: 40 mg RP-3467 QD+300 mg BID Ola	1 of 13 (7.7%)	11 of 13 (84.6%)	0 of 13

Limitations and caveats (from the sponsor): The Study was terminated early by the Sponsor

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced Solid Tumor

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RP-3467 at assigned dose and schedule and Olaparib 200-300 mg BID, daily in people with Advanced Solid Tumor, run by Repare Therapeutics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment (time frame: Start of treatment to 30 days post last dose, up to 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.