Advanced Malignancies, Cancer, Colorectal Cancer, Oncology, Pancreatic Cancer
Conditions
Keywords
advanced malignancies, colorectal cancer, pancreatic ductal adenocarcinoma
Brief summary
Phase 1/2a Study of RP-001 in participants with Advanced Malignancies
Detailed description
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
Interventions
DRUGRP-001
A new class of Taxane.
Sponsors
Recurv Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the safety and tolerability of RP-001 administered as monotherapy. | 1 month | • Dose limiting toxicities (DLTs) and adverse events (AEs) using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the recommended Phase 2 dose | one month | Determination of maximum tolerated dose level |
Contacts
CONTACTJennifer W Curry, PharmD
Outcome results
None listed