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CTX-712

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Apr 13, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment225

FDA Designations

No designations recorded

Clinical trial landscape

CTX-712 · 1 trial · 2 indications

Phase 1 1
NCT05732103A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic SyndromesAcute Myeloid Leukemia
RECRUITING225 Analytics
PHASE1RECRUITING
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.
Phase 1: The maximum tolerated dose MTD.
Dose-limiting toxicities are collected during the first treatment cycle (28 days).

MTD is the dose producing \<33% of dose-limiting toxicities.

Phase 2: Complete remission rate, defined as the proportion of patients who achieve complete remission.
Measured from date of first dose to 28 days after last dose of CTX-712.

Secondary Endpoints

Phase 1 and 2: Objective response rate, defined as the proportion of patients achieving a response.
Measured from date of first dose to 28 days after last dose of CTX-712.
Phase 1 and 2: Duration of response.
Measure from documentation of tumor response to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Phase 1 and 2: Progression-free survival.
Measured from the date of initiating study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation CohortEXPERIMENTALDrug: CTX-712 administered at 20 mg, 40 mg, 80 mg, 100 mg, 140 mg weekly, or 60 mg, 80 mg, 100 mg twice a week
Initial Expansion CohortEXPERIMENTALDrug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort
Phase 2EXPERIMENTALCTX-712 administered at the recommended dose by the expansion cohort

Interventions

NameTypeDescription
CTX-712DRUGCTX-712 will be provided as a 20 mg tablet for oral administration. Patients will take CTX-712 once or twice weekly, depending on their dose level assignment, during each 28-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion criteria: 1. Age ≥18 years. 2. Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion cohorts. 3. Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for ...

Countries:United States
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Frequently asked questions about CTX-712

What is CTX-712 used for?

CTX-712 is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is also being studied in higher risk Myelodysplastic Syndromes (MDS). The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes CTX-712?

CTX-712 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational oncology drug candidate.

What phase is CTX-712 in?

CTX-712 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a Phase 1 trial for relapsed or refractory Acute Myeloid Leukemia and higher risk Myelodysplastic Syndromes.

What clinical trials is CTX-712 in?

CTX-712 is being studied in a Phase 1 clinical trial with the identifier NCT05732103. This trial is recruiting participants in the United States and is investigating the drug in patients with relapsed or refractory Acute Myeloid Leukemia and higher risk Myelodysplastic Syndromes. The trial has a planned enrollment of 225 participants.

Is CTX-712 the same as any other drug?

CTX-712 is the primary name for this investigational drug candidate. No alternative names have been reported for this compound. It is a small molecule being developed for oncology indications, specifically Acute Myeloid Leukemia and Myelodysplastic Syndromes.