Phase 1/2a Study of RP-001 in Participants With Advanced Malignancies

ConditionsAdvanced Malignancies Oncology Colorectal Cancer Pancreatic Cancer Cancer

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRecurv Pharma Inc

About this trial

Phase 1/2a Study of RP-001 in participants with Advanced Malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Phase 1: Participants with solid tumors who are candidates for treatment with a taxane

Phase 2a: Participants with relapsed or refractory PDAC, or CRC.

Disqualifiers

1. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.

Trial design

Design model

Sequential

Treatments tested in this trial

RP-001
Drug
A new class of Taxane.

Treatment groups

66 Participants

are divided into 5 treatment groups

Group A: 12mg of RP-001Experimental treatment 1 intervention

Group B: 25mg of RP-001Experimental treatment 1 intervention

Group C: 75mg of RP-001Experimental treatment 1 intervention

Group D: 150mg of RP-001Experimental treatment 1 intervention

Group E: 250mg of RP-001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

To characterize the safety and tolerability of RP-001 administered as monotherapy.

• Dose limiting toxicities (DLTs) and adverse events (AEs) using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v5.0

Time frame

1 month

Secondary outcomes

To determine the recommended Phase 2 dose

Determination of maximum tolerated dose level

Time frame

one month

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Recurv Pharma Inc

Lead sponsor

Source ClinicalTrials.gov

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