Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants will receive revumenib tablets or capsules three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle.

Participants will receive revumenib tablets TID or BID from Day 1 of each 28-day cycle.

Participants will receive chemotherapy from Day 1 of each 28-day cycle.

Revumenib administered orally with or without food. Participants may continue to receive treatment until disease progression or until they experience unacceptable toxicity.

Revumenib

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.

Chemotherapy

Syndax Pharmaceuticals

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.

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.

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

Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Neoplasms

Leukemia, Biphenotypic, Acute

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Leukemia, Lymphoid

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Leukemia of Ambiguous Lineage

Cohort 1: KMT2A-r / NPM1-m patients will receive a dose previously studied in Phase 1a

Cohort 2: KMT2A-r / NPM1-m patients will receive a dose previously studied in Phase 1a

NPM1-m patients will receive the recommended phase 2 dose determined in Phase 1

Ziftomenib

Clinical Operations

Joshua Sandolo

Christine Duran

Bruck Habtemariam

Jill Weisenbach, RN

Larissa Sanglard, MD

Christine Connolly

Emily Tolksdorf

Cancer Center Clinical Trials Referral Office

Lumi Demirovic

Tania Curcio

Tina Czaplinska

hematologyresearch@duke.edu

Silas Day

Felicia Kass

Recruitment and Eligibility Office

Yasmeen Akhtar, MBBS,MS,CCRP

Rachel Abramowicz

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.

This Phase 1/2, first-in-human (FIH), open-label, dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML).

The dose-escalation part of the study (Phase 1a) will determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).

The dose-validation/expansion part of the study (Phase 1b) will determine the safety, tolerability, and minimal biologically effective dose of ziftomenib in dosing cohorts which have demonstrated early biological activity and have been determined to be safe in the dose-escalation phase.

The Phase 2 portion of the study will determine the safety, tolerability, and anti-leukemia activity of ziftomenib in patients with NPM1-m AML.

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

MTD is defined as the highest dose that is not expected to cause dose limiting toxicity (DLT) in more than 20% of patients.

Minimal biologically effective dose in dosing cohorts which have demonstrated biological activity and have been determined to be safe as a part of Part 1a

Anti-leukemia activity is assessed by the CR (CR+CRh) rate

Time to observed maximum plasma concentration of ziftomenib and/or its metabolites

Area under the plasma concentration-time curve from time 0 to time of last measurable concentration of ziftomenib and/or its metabolites

Maximum plasma concentration of ziftomenib and/or its metabolites

To assess the CR rate with and without MRD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors	NCT05731947	Colorectal Canc... Solid Tumors	Revumenib Chemotherapy	18 Years -	Syndax Pharmaceuticals
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia	NCT04067336	Advanced Malign... Acute Myeloid L... Mixed Lineage L... Mixed Lineage A... Acute Leukemia ... Mixed Phenotype...	Ziftomenib	18 Years -	Kura Oncology, Inc.
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia	NCT04067336	Advanced Malign... Acute Myeloid L... Mixed Lineage L... Mixed Lineage A... Acute Leukemia ... Mixed Phenotype...	Ziftomenib	18 Years -	Kura Oncology, Inc.

Spots Global Cancer Trial Database for menin

Every month we try and update this database with for menin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for menin

Every month we try and update this database with for menin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for menin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.