CTX-712 for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Guillermo Garcia-Manero

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Chordia Therapeutics, Inc.

Disqualifiers: CNS leukemia, Other malignancy, Heart failure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CTX-712 to see if it is safe and effective for patients with certain types of blood cancer that have not responded to other treatments. The study will first determine the best dose and then check how well the drug works and if it is safe.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

Research Team

Guillermo Garcia-Manero

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults (18+) with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes, who have undergone 1-4 prior treatments. Participants must have adequate organ function and blood counts, agree to contraception if of childbearing potential, and not be suffering from severe lung disease or recent major surgery.

Inclusion Criteria

I agree to use effective contraception or practice abstinence during and for four months after the study.

My kidney, liver, and blood tests are within normal ranges.

I am not pregnant, can take a test to prove it, and will use effective birth control during and up to 4 months after the study.

Exclusion Criteria

I have not had a heart attack in the last six months.

I have heart rhythm problems not managed by medicine.

I have not had major surgery in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D)

28 days per cycle

Weekly visits for dose administration

Dose Expansion

Additional patients are treated with CTX-712 at the RP2D to gain further confidence in the selected dose level

Duration not specified

Phase 2 Treatment

Evaluation of therapeutic activity and confirmation of the safety profile in R/R AML or R/R HR-MDS

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CTX-712 (Other)

Trial Overview The trial is testing CTX-712's safety and effectiveness in two phases. Phase 1 determines the best dose through a '3+3' method where small groups receive increasing doses. Phase 2 evaluates its therapeutic activity at this established dose in patients with specific types of leukemia.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

CTX-712 administered at the recommended dose by the expansion cohort

Group II: Dose Expansion Cohort Experimental Treatment 1 Intervention

Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort

Group III: Dose Escalation Cohort Experimental Treatment 1 Intervention

Drug: CTX-712 administered at 20 mg, 40 mg, 80 mg, 100 mg, 140 mg weekly

Who Is Running the Clinical Trial?

Chordia Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

170+

Theradex

Industry Sponsor

Trials

34

Recruited

1,600+