Clinical trial · Interventional
Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
- 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 therefore, the Phase 2 portion was not conducted
Summary
Brief summary (as posted)
The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib), in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 (camonsertib) in combination with niraparib or olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.
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, Adult | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP-3500 (camonsertib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase Ib Dose Escalation
- description
- Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with niraparib and/or Multiple dose levels of RP-3500 (camonsertib) for oral administration in combination with olaparib
- interventionNames
- Drug: RP-3500 (camonsertib)
- type
- EXPERIMENTAL
- label
- Phase 2 Expansion Cohorts
- description
- Expansion cohort with RP-3500 (camonsertib) + niraparib and/or Expansion cohort RP-3500 (camonsertib) + olaparib
- interventionNames
- Drug: RP-3500 (camonsertib)
Primary outcomes (2)
- measure
- Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female and ≥18 years-of-age at the time of signature of the informed consent * Confirmed advanced solid tumors resistant or refractory to standard treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Evaluable disease as per RECIST v1.1 * Next generation sequencing (NGS) report obtained in CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers. * Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible * Acceptable hematologic and organ function at screening * Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug. * Ability to swallow and retain oral medications. Exclusion Criteria: * Prior therapy with an ATR or DNA-dependent protein kinase (DNA-PK) inhibitor. * Chemotherapy, small molecule anticancer or biologic anticancer therapy given within 10 days or 5 half-lives (whichever is longer), prior to first dose of study drug. * Use of radiotherapy (except for palliative reasons) within 7 days prior to first dose of study drug. * 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. * No other anticancer therapy is to be permitted while the patient is receiving study treatment. * Major surgery ≤28 days or minor surgical procedures ≤7 days prior to first study treatment dose. * Uncontrolled, symptomatic brain metastases. * Uncontrolled high blood pressure * History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis * Presence of other known active invasive cancers. * Pregnant or breastfeeding women. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study protocol and/or follow-up procedures outlined in the protocol.
References
Publications (1)
- DERIVEDSilverman IM, Schonhoft JD, Herzberg B, Yablonovitch A, Lagow E, Fiaux PC, Safabakhsh P, Sethuraman S, Ulanet D, Yang J, Kim I, Basciano P, Cecchini M, Lee E, Lheureux S, Fontana E, Carneiro BA, Reis-Filho JS, Yap TA, Zinda M, Rosen EY, Rimkunas V. Genomic and Epigenomic ctDNA Profiling in Liquid Biopsies from Heavily Pretreated Patients with DNA Damage Response-Deficient Tumors. Clin Cancer Res. 2025 Oct 1;31(19):4136-4149. doi: 10.1158/1078-0432.CCR-25-1248. PMID 40705098