Actively Recruiting
A Study to Determine the Effect of CT3001 in Patients with Advanced Solid Tumors
Led by Crossignal Therapeutics, Inc. · Updated on 2024-11-04
78
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Determine the Effect of CT3001 in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give voluntary informed consent and follow all study procedures
- Aged 18 years or older
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors refractory to standard therapy or without standard therapy options
- In Phase 2a, participants must have advanced colorectal carcinoma or pancreatic ductal adenocarcinoma refractory to standard therapy or without standard therapy options
- Measurable disease per RECIST Version 1.1 not in prior radiation or treated area unless progression after treatment is documented
- Life expectancy of at least 3 months as judged by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function: neutrophils ≥ 1.5 × 10^9/L, hemoglobin ≥ 9.0 g/dL, platelets ≥ 75 × 10^9/L without recent transfusions or growth factors
- Adequate liver function: total bilirubin < 1.5 × upper limit normal (ULN), AST and ALT < 3 × ULN
- Adequate kidney function: creatinine clearance > 60 mL/min per Cockcroft-Gault equation
- Coagulation tests: INR < 1.5, aPTT ≤ 1.5 × ULN (INR 2-3 acceptable if on anticoagulants)
- Participants of childbearing potential willing to use effective contraception during and for 3 months after treatment; postmenopausal women confirmed by hormone testing
- Male participants willing not to donate sperm during treatment and for 3 months after last dose
You will not qualify if you...
- Receiving concurrent anticancer treatments including chemotherapy, targeted drugs, radiotherapy (except small-area radiotherapy for bone metastasis), endocrine therapy, or antitumor traditional Chinese medicine
- Use of other investigational products within 5 half-lives or investigational devices within 2 weeks before CT3001 treatment, except approved monoclonal antibodies
- Severe or uncontrolled systemic diseases or infections that could interfere with participation
- Females who are pregnant, nursing, or planning pregnancy during the study
- Major surgery or significant injury within 4 weeks before starting CT3001 or not recovered from such events
- Prolonged QT interval > 470 ms or risk factors for Torsade de Pointes
- Psychiatric, psychological, familial, or geographic conditions interfering with compliance or safety
- Blood donation or significant blood loss within 60 days prior to treatment
- History of severe allergy or sensitivity to CT3001 or its components
- Vaccination with live vaccine within 4 weeks prior to treatment
- Use of immune suppressing drugs or medications metabolized by CYP2C8 within 5 half-lives before treatment
- Use of gastric acid reducing agents between 6 hours before and 2 hours after CT3001 administration
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or HIV antibodies unless meeting specific controlled infection criteria
- Any condition the investigator judges would jeopardize participant safety, study participation, or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Can Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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