Description:
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in
patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and
assess preliminary anti-tumor activity.
Title
- Brief Title: Study of RP-6306 in Advanced Solid Tumors
- Official Title: Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)
Clinical Trial IDs
- ORG STUDY ID:
RP-6306-01
- NCT ID:
NCT04855656
Conditions
Interventions
Drug | Synonyms | Arms |
---|
RP-6306 | | Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study |
Purpose
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in
patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and
assess preliminary anti-tumor activity.
Detailed Description
Phase 1, multi-center, open-label, dose-escalation study to:
- Evaluate the safety profile and MTD of RP-6306 when administered orally to establish the
recommended Phase 2 dose and schedule
- Characterize the PK and pharmacodynamics of RP-6306 monotherapy
- Assess preliminary anti-tumor activity associated with RP-6306 monotherapy
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study | Experimental | Patients receive RP-6306 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. | |
Eligibility Criteria
Inclusion Criteria:
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1,
or 2 for patients >16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients <18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy
performed if safe and feasible
- Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent
laboratory demonstrating eligible tumor biomarker.
- 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.
- Any prior radiation must have been completed at least 7 days prior to the start of
study drugs, and patients must have recovered from any acute adverse effects prior to
the start of study 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.
- 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.
- Uncontrolled, symptomatic brain metastases.
- Uncontrolled hypertension.
- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol and/or follow-up procedures outlined in the protocol.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and Tolerability of RP-6306 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0 |
Time Frame: | Up to 90 days after last administration of study intervention |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | To assess PK parameters of RP-6306 monotherapy in fasted and fed states |
Time Frame: | through study completion, an average of 1 year |
Safety Issue: | |
Description: | |
Measure: | To assess the relationship between pharmacodynamic biomarkers and PK of RP-6306 at different dose levels and/or schedules |
Time Frame: | for the first 3 months on treatment |
Safety Issue: | |
Description: | |
Measure: | To assess preliminary anti-tumor activity of RP-6306 monotherapy |
Time Frame: | Through Study Completion, an average of 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Repare Therapeutics |
Last Updated
May 13, 2021