Study of RP-3500 With Niraparib or Olaparib in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repare Therapeutics
• Treatments: Niraparib; Olaparib

Criteria

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.

• Measurable 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.