NCT06598007 A Study to Determine the Effect of CT3001 in Patients with Advanced Solid Tumors

Trial Parameters

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Brief Summary

This is an FIH, multicenter, open-label, dose escalation and dose expansion study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2a. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 6 dose levels of CT3001. Phase 2a is a dose expansion study to evaluate the preliminary efficacy of CT3001 in patients with advanced CRC or PDAC.

Eligibility Criteria

Inclusion Criteria: * Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures. * Aged ≥ 18 years (or adult age as per local regulations). * Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2a, only participants with locally advanced CRC or PDAC that are refractory to standard therapy, or for whom no standard therapy exists, will be enrolled. * Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy. * Life expectancy ≥ 3 months, in the opinion of the PI or designee. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, liver, and kidney function as follows: Bone marrow reser

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