RecruitingPhase 1Phase 2NCT06598007

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

A Phase 1/2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors

Sponsor

Crossignal Therapeutics, Inc.

Enrollment

78 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Pancreatic Ductal Adenocarcinoma Solid Tumor, Adult

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental cancer drug called CT3001 in patients with advanced solid tumors (particularly colorectal cancer and pancreatic cancer) that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic solid cancer that has progressed on standard therapies - You have measurable disease on imaging - You have good functional status (ECOG 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You are currently receiving other cancer treatments - You have had major surgery within the past 4 weeks - You are pregnant or planning to become pregnant - You have active hepatitis B, hepatitis C, or HIV (in most cases) - You have had severe allergic reactions to similar drugs - You have a prolonged QT interval on your ECG or take medications that prolong it Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCT3001

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

DRUGFOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX will be administered Q2W per institutional standard.