Clinical trial · Interventional
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to terminate study early
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib 200-300 mg BID, daily | Drug | Olaparib | ALIAS |
| RP-3467 at assigned dose and schedule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: RP-3467 monotherapy
- description
- Eligible participants will be treated with escalating doses of RP-3467 monotherapy
- interventionNames
- Drug: RP-3467 at assigned dose and schedule
- type
- EXPERIMENTAL
- label
- Arm2: RP-3467 + Olaparib combination
- description
- Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib
- interventionNames
- Drug: RP-3467 at assigned dose and schedule
- Drug: Olaparib 200-300 mg BID, daily
Primary outcomes (1)
- measure
- The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or 2. metastatic breast cancer, or 3. metastatic castration-resistant prostate cancer (mCRPC), or 4. 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available