Trial Title:
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
NCT ID:
NCT05732103
Condition:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CTX-712
Description:
CTX-712 will be provided as a 20 mg tablet for oral administration. Patients will take
CTX-712 weekly, depending on their dose level assignment, during each 28-day cycle.
Arm group label:
Dose Escalation Cohort
Arm group label:
Dose Expansion Cohort
Arm group label:
Phase 2
Summary:
The goal of this phase 1/2 multicenter, open-label, singe 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).
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 a confirmatory phase
1 expansion cohort where an additional approximately 10 patients will be treated with
CTX-712 at the RP2D to gain further confidence in the selected dose level. 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.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Age ≥18 years.
2. Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML).
3. Prior treatment history must include 1-4 prior lines of therapy.
4. Adequate organ function evidenced by the following laboratory values:
Creatinine clearance (CL) ≥60 mL/min Total serum bilirubin < 1.5 × upper limit of
normal (ULN) Alanine aminotransferase (ALT) Aspartate aminotransferase(AST) < 2.5 ×
ULN White blood cell count at the time of the first dose <10 k/μL
5. Eastern Cooperative Oncology Group performance status ≤2.
6. Female patients of childbearing potential must have a negative pregnancy test within
7 days before study treatment initiation and if sexually active, agree to use a
highly effective form of contraception throughout their participation during study
treatment and up to 4 months after the last dose of study drug
7. Male patients with female partners of childbearing potential must, even if
surgically sterilized, agree to practice effective barrier contraception during the
entire study treatment period and through four months after the last dose of study
drug, or practice true abstinence, when this is in line with the preferred and usual
lifestyle of the participant.
Exclusion criteria:
1. Diagnosis of acute promyelocytic leukemia.
2. Isolated extramedullary relapse (phase 2 only).
3. Active central nervous system (CNS) leukemia.
4. History of other malignancy.
5. Any of the following cardiopulmonary abnormalities:
1. Myocardial infarction within six months prior to registration.
2. New York Heart Association Class III or IV heart failure or known left
ventricular ejection fraction < 50%.
3. A history of familial long QT syndrome.
4. Symptomatic atrial or ventricular arrhythmias not controlled by medications.
5. QTcF ≥ 470 msec calculated according to institutional guidelines, unless due to
underlying bundle branch block and/or pacemaker and with approval of the
medical monitor.
6. Known moderate to severe and clinically significant chronic obstructive
pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g.,
requiring home oxygen therapy).
6. Pregnancy and/or lactation.
7. Major surgery (excluding placement of vascular access) within 4 weeks prior to first
dose of CTX-712.
8. History of allogeneic organ transplantation (excluding cornea).
9. History of allogenic hematopoietic stem cell transplantation within 6 months of
planned study treatment initiation and/or graft-versus host disease grade ≥ 1
following allogenic hematopoietic stem cell transplantation.
10. History of or chimeric antigen receptor T-cell therapy or other modified T cell
therapy.
11. Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B
virus, hepatitis C virus, known human immunodeficiency virus, or acquired
immunodeficiency syndrome related illness. Infections controlled with oral
anti-infective agents, including prophylactic treatments, are allowed. Patient must
be viral load negative.
12. Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol and/or follow-up procedures outlined in the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Investigator:
Last name:
Cecilia A Yi, MD, MSHS
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Investigator:
Last name:
James Foran, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Comprehensive Cancer Center
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Investigator:
Last name:
Antoine Saliba, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristy Bodden
Phone:
713-563-4412
Email:
krbodden@mdanderson.org
Start date:
April 25, 2023
Completion date:
April 2028
Lead sponsor:
Agency:
Chordia Therapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Theradex
Agency class:
Industry
Source:
Chordia Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732103
