Open Actively Recruiting

Study of RP-6306 Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors


Brief Summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

Primary Purpose
Study Type
Phase 1


Healthy Volunteers
Minimum Age
12 Years
Maximum Age

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 module 1) 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.
  • CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
  • FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
  • PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
  • Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible
  • 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.
  • Certain prior anti-cancer therapy
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Join this Trial

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Study Stats
Protocol No.
Ovarian Cancer
Temitope Oladimeji
  • UCLA Westwood
For Providers
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