Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/04/2024. Questions regarding updates should be directed to the study team contact.