LY3410738 for Blood Cancers

Recruiting at 41 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Venetoclax, PPIs, Strong CYP3A4 drugs

Disqualifiers: Concurrent malignancy, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

260 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with advanced blood cancers (like AML) that have specific IDH1 or IDH2 mutations. Participants must be able to take oral medication, follow birth control measures if of reproductive potential, and have an ECOG score of 0-2 indicating they are relatively active. They can't join if they've had certain recent treatments, other active cancers, major surgery, uncontrolled infections, significant heart issues, or been on strong CYP3A4 inhibitors.

Inclusion Criteria

-- For Dose Escalation Arm C and Dose Expansion Cohort 5:

Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation

My cancer has a specific IDH1 or IDH2 mutation.

Exclusion Criteria

I have never been treated with venetoclax.

Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the Investigator would contraindicate the patient's participation in the study or confound the results of the study

I have not had major surgery in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of LY3410738 to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Up to 30 months

Dose Expansion

Participants are enrolled into 5 cohorts to further evaluate safety and clinical activity of LY3410738

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• LY3410738

Trial Overview The study tests LY3410738—an oral drug targeting mutated enzymes in blood cancer cells—alone or with standard therapies like Venetoclax and Azacitidine. It's a Phase 1 trial where everyone gets the experimental treatment but at different doses to find the safest and most effective amount.

Participant Groups

Group I: Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine) Experimental Treatment 3 Interventions

Patients with no prior venetoclax therapy and not requiring a strong CYP3A4 inhibitor for active treatment within 7 days of starting LY3410738.

Group II: Dose Escalation Arm B (Monotherapy) Experimental Treatment 1 Intervention

Patients requiring a strong CYP3A4 inhibitor for active management or prevention of a lifethreatening condition, such as an azole administered to prevent invasive fungal infection.

Group III: Dose Escalation Arm A (Monotherapy) Experimental Treatment 1 Intervention

Patients not requiring a strong cytochrome P450 3A4 (CYP3A4) inhibitor.

Group IV: Cohort 5 Experimental Treatment 3 Interventions

Patients with newly diagnosed AML, R/R AML, or other advanced hematologic malignancy harboring IDH1 and/or IDH2 mutations with no prior venetoclax therapy. Strong CYP3A4 inhibitor allowed but not required.

Group V: Cohort 4 Experimental Treatment 1 Intervention

Patients with R/R AML, MDS, CMML or other advanced hematologic malignancy harboring IDH2 mutations.

Group VI: Cohort 3 Experimental Treatment 1 Intervention

Patients with R/R MDS, chronic myelomonocytic leukemia (CMML) or other advanced hematologic malignancy harboring an IDH1 R132 mutation.

Group VII: Cohort 2 Experimental Treatment 1 Intervention

Patients with R/R AML harboring an IDH1 R132 mutation who have not received a prior IDH inhibitor.

Group VIII: Cohort 1 Experimental Treatment 1 Intervention

Patients with relapsed/refractory (R/R) AML harboring an IDH1 R132 mutation who have received a prior IDH inhibitor.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology