Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.

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

Details

• Lead Sponsor: Repare Therapeutics
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Male or female and ≥18 years-of-age at the time of informed consent.

• ECOG Performance status 0 or 1.

• Locally advanced or metastatic resistant or refractory solid tumors.

• Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.

• Measurable disease as per RECIST v1.1.

• Ability to swallow and retain oral medications.

• Acceptable hematologic and organ function at screening.

• Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.

• Resolution of all toxicities of prior therapy or surgical procedures.

• Life expectancy ≥12 weeks after the start of the treatment

Exclusion Criteria:

• Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half- lives, whichever is shorter, 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.

• Patients who are pregnant or breastfeeding.

• Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.

• Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.

• Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine.

• Uncontrolled, symptomatic brain metastases.

• Uncontrolled hypertension.

• Moderate or severe hepatic impairment

• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.