Trial Title:
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
NCT ID:
NCT05731947
Condition:
Colorectal Cancer
Solid Tumors
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
SNDX-5613
Revumenib
Menin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1a dose escalation portion of the study will employ a Rolling 6 trial design,
followed by a Phase 1b signal-seeking portion, and a Phase 2 randomized (2:1) signal
confirmation portion.
Phase 1: Non-randomized; Phase 2: Randomized
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Revumenib
Description:
Revumenib administered orally with or without food. Participants may continue to receive
treatment until disease progression or until they experience unacceptable toxicity.
Arm group label:
Phase 1a: Dose Escalation
Arm group label:
Phase 1b: Signal-Seeking
Arm group label:
Phase 2: Revumenib
Other name:
SNDX-5613
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective
drug label's dose and schedule. Participants may continue to receive treatment until
disease progression or until they experience unacceptable toxicity.
Arm group label:
Phase 2: Chemotherapy
Summary:
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor
activity of revumenib in participants with colorectal cancer (CRC) or other solid tumors
who have failed at least 1 prior line of therapy.
Detailed description:
The study will be conducted in two parts. The Phase 1 portion of the study consists of a
dose escalation cohort, and a signal-seeking expansion where anti-tumor activity signals
will be evaluated. The Phase 2 portion of the study will further confirm the anti-tumor
activity signals of revumenib.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Male and female participants aged ≥18 years
- Participants with metastatic CRC or other solid tumors
- Evidence of locally recurrent or metastatic disease based on imaging studies within
28 days of cycle 1/day 1 (C1D1)
- CRC participants must have had at least one line of standard-of-care therapy and
must have progressed on or been intolerant to, or unable to receive oxaliplatin,
irinotecan, and bevacizumab in the advanced/metastatic setting.
- Other solid tumor participants must have had all approved standard therapies that
are available to the participant, unless contraindicated or intolerable.
- Participants must have experienced documented unequivocal progressive disease by
either RECIST v1.1 or clinical assessment, or experienced unacceptable toxicity with
their prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- If receiving radiation therapy, has had a 2-week washout period following completion
of the treatment prior to receiving the C1D1 dose and continues to have at least 1
measurable lesion
- At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint
inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy
or other modified T-cell therapy
- Adequate bone marrow, renal, cardiac, and liver function
Key Exclusion Criteria:
- Participant has a prior history of malignant bowel obstruction requiring
hospitalization in the 6 months prior to enrollment
- Participant has a history of uncontrolled ascites, defined as symptomatic ascites
and/or repeated paracenteses for symptom control in the past 3 months
- Detectable human immunodeficiency virus (HIV) viral load within the previous 6
months. Participants with a known history of HIV 1/2 antibodies must have viral load
testing prior to study enrollment
- Hepatitis B and/or C
- Any of the following within the 6 months prior to study entry: myocardial
infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart
Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia,
cerebrovascular accident, or transient ischemic attack
- Corrected QT interval (QTc) >450 milliseconds
- Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug
absorption or ingestion (for example, gastric bypass, gastroparesis)
- Cirrhosis with a Child-Pugh score of B or C
- Brain metastasis except for those participants who have completed definitive
therapy, are not on steroids, have a stable neurologic status for at least 4 weeks
after completion of the definitive therapy and steroids, and do not have neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
events (AEs)
- History of or any concurrent condition, therapy, laboratory abnormality, or allergy
to excipients that in the Investigator's opinion might confound the results of the
study, interfere with the participant's ability to participate for the full duration
of the study, or not be in the best interest of the participant to participate
- Participant has received prior chemotherapy, targeted small molecule therapy, or
radiation therapy within 2 weeks prior to study baseline or who has not recovered
(that is, ≤Grade 1 or at baseline) from AEs related to a previously administered
agent.
- Participation in another therapeutic interventional clinical study in which an
investigational agent was administered within 30 days before starting revumenib
- Participant has received a transfusion of blood products or administration of colony
stimulating factors within 4 weeks of the first dose of the study drug
- History of additional malignancy within the prior 5 years, excluding adequately
treated basal cell carcinoma, squamous cell of the skin, cervical intraepithelial
neoplasia/cervical carcinoma in situ, or melanoma in situ or ductal carcinoma in
situ of the breast
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
Manhattan
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
April 4, 2023
Completion date:
August 2027
Lead sponsor:
Agency:
Syndax Pharmaceuticals
Agency class:
Industry
Source:
Syndax Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731947
