A Phase 1/2a 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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 reserve:

⁃ Absolute neutrophil count ≥ 1.5 × 10\^9/L without growth factor support in the 2 weeks prior to study entry.

⁃ Hemoglobin ≥9.0 g/dL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.

⁃ Platelet count ≥ 75 × 10\^9/L without transfusion in 2 weeks prior to study entry.

‣ Hepatic function:

⁃ Serum TBIL \< 1.5 × ULN.

⁃ AST and ALT \< 3 × ULN.

‣ Renal function:

‣ Serum creatinine clearance (CrCL) \> 60 mL/min, as per the Cockcroft-Gault Equation:

‣ CGGFR = \[(140 - age in years) × weight in kg\] / (7.2 × serum creatinine in mg/dL) (× 0.85 for females) (for urine protein \< 2+; if urine protein \> 2+, 24-hour urinary protein quantity should be measured and must be \< 1.0 g).

• Coagulation tests: international normalized ratio (INR) \< 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).

• Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU/L. Male participants must be willing not to donate sperm until 3 months following the last IP administration.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Can Zhang
czhang@crossignaltherapeutics.com
413-932-9263
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 78
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Crossignal Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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