An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of RP-001 in Participants with Advanced Malignancies
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female participants aged 18 years or older with advanced or metastatic cancer, which must be measurable per RECIST v1.1 and satisfy the following criteria:
* Phase 1: Participants with solid tumors who are candidates for treatment with a taxane
* Phase 2a: Participants with relapsed or refractory PDAC, or CRC.
You may not be if
1\. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.
2\. Cardiovascular disease, including:
a. Unstable angina; b. symptomatic peripheral arterial vascular disease; c. Myocardial infarction within 6 months prior to RP-001 administration; d. New York Heart Association Class III or IV heart failure; e. Uncontrolled arrythmia; f. ECG abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the trial.
3\. Concurrent systemic anti-cancer therapy other than luteinizing hormone-releasing hormone (LH-RH) agonists.
4\. Pregnancy, or breastfeeding. 5. Untreated central nervous system metastasis, or carcinomatous meningitis. 6. Any concurrent severe and/or uncontrolled medical or surgical condition which, in the opinion of the Investigator, may compromise the participant's involvement in the trial due to safety, compliance concerns or ability to evaluate response.
Clareo Health | Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies
