Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Debiopharm

Status and phase

Terminated

Phase 1

Conditions

Adult Solid Tumor

Treatments

Drug: RP-6306 (oral PKMYT1 inhibitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05147272

RP-6306-02

Details and patient eligibility

About

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.

Full description

Phase 1, multi-center, open-label, dose-escalation study to:

Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule
Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine
Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine

The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.