JNJ-74856665 for AML and MDS (DHODH Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called JNJ-74856665, alone or with other drugs, in patients with specific blood cancers like AML, MDS, and CMML. The goal is to see if it can safely stop cancer cells from growing and make them die.

Eligibility Criteria

This trial is for adults with certain blood disorders like AML or MDS who've tried other treatments without success, or can't use them. It's also for those unsuitable for intensive treatment but can take AZA, and some with lower-risk MDS needing regular blood transfusions. Participants must be in good physical condition and women/men agree to contraception.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

You have been diagnosed with certain types of blood cancers or disorders and have exhausted or are not eligible for standard treatment options. This includes acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia-2 (CMML-2). In some cases, you may be eligible if you are not suitable for intensive treatment or stem cell transplantation.

Exclusion Criteria

I am allergic to JNJ-74856665, AZA, VEN, or their ingredients.

I have been diagnosed with a specific type of leukemia.

My cancer has spread to my brain or spinal cord.

I have been treated with or cannot tolerate a DHODH inhibitor for cancer or other reasons.

Side effects from my previous cancer treatments, except for hair loss, nerve issues, low platelet count, low white blood cell count, or anemia, have mostly gone away.

Treatment Details

The study tests JNJ-74856665 alone or combined with AZA (Azacitidine) or VEN (Venetoclax), aiming to find the safest doses. The focus is on how well patients tolerate these drugs and what effects they have on their diseases.

4Treatment groups

Experimental Treatment

Group I: Arm D: JNJ-74856665Experimental Treatment1 Intervention

Participants will receive JNJ-74856665 orally in a 21-day cycle. Participants with transfusion dependent relapsed/refractory Myelodysplastic Syndrome (MDS) will be included.

Group II: Arm C: JNJ-74856665 + Venetoclax (VEN)Experimental Treatment2 Interventions

Participants will receive JNJ-74856665 orally in combination with VEN in a 28-day cycle.

Group III: Arm B: JNJ-74856665 + Azacitidine (AZA)Experimental Treatment2 Interventions

Participants will receive JNJ-74856665 orally in combination with AZA administered intravenously (IV) or subcutaneously (SC) in a 28-day cycle.

Group IV: Arm A: JNJ-74856665Experimental Treatment1 Intervention

Participants will receive JNJ-74856665 orally in a 21-day cycle. The dose levels will be escalated based on the decisions of the Study Evaluation Team (SET) until a recommended Phase 2 dose (RP2D) has been identified.