A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CTX-712 — DRUG
  CTX-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.

Study Details

The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the RP2D to gain further confidence in the selected dose level. Additional expansion cohorts may be initiated if considered necessary. After RP2D is determined, Drug-Drug-Interaction cohorts will be started. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and will evaluate therapeutic activity in R/R AML or R/R HR-MDS, in addition to confirmation of the safety profile.

Key Dates

Start date

Apr 25, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

225 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Cohort
  Drug: 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
• Experimental: Initial Expansion Cohort
  Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort
• Experimental: Phase 2
  CTX-712 administered at the recommended dose by the expansion cohort

Primary Outcome Measure

Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712. [ Time Frame: Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712. ]

Central Contacts

• Laurie F Graham, RN, MSN
  (609) 608-2152
  [email protected]
• Haris Durutlic
  (781) 560-4419
  [email protected]

Locations (8)

Find similar trials in Phoenix, AZ

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