Open Actively Recruiting
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
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.
- 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
- 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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Head and Neck Cancer
- UCLA Westwood
For detailed technical eligibility, visit ClinicalTrials.gov.