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

Part of paid clinical trials in Houston, Texas.

Sponsor
Crossignal Therapeutics, Inc.
Study ID
NCT06598007
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT3001 — DRUG
    CT3001 is an Oral Solution, with active pharmaceutical agent, a small molecule inhibitor of GPR35, formulated with PEG 400, strawberry flavor, and anhydrous ethanol.
  • FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) — DRUG
    FOLFOX will be administered Q2W per institutional standard.

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
May 2026
Primary completion
Jun 20, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CT3001 50mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 100mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 200mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 300mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 500mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 700mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 1000mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.
  • Experimental: CT3001 400mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing in ongoing cycles. CT3001 will be administered in combination with FOLFOX (Q2W).
  • Experimental: CT3001 600mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing in ongoing cycles. CT3001 will be administered in combination with FOLFOX (Q2W).
  • Experimental: CT3001 800mg
    Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing in ongoing cycles. CT3001 will be administered in combination with FOLFOX (Q2W).

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs). [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Katherine Torres
[email protected]
832-750-4997
Jing Peng
[email protected]
713-792-2208
Siqing Fu, MD, PhD (PRINCIPAL_INVESTIGATOR)

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