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

NCT06598007 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-19

No results posted yet for this study

Summary

This is an FIH, multicenter, open-label, dose escalation and dose expansion/dose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. 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 7 dose levels of CT3001. Phase 2b is a dose finding/dose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.

Conditions

Interventions

DRUG

CT3001

CT3001 is an Oral Solution, with active pharmaceutical agent, a small molecule inhibitor of GPR35, formulated with PEG 400, strawberry flavor, and anhydrous ethanol.

DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX will be administered Q2W per institutional standard.

Sponsors & Collaborators

  • Crossignal Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Zhi (Zak) Liang Chu, Ph.D. · Crossignal Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2027-06-20
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598007 on ClinicalTrials.gov