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LY3410738 · 2 trials · 8 indications
For Dose Escalation
For Dose Expansion
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm A (Monotherapy) | EXPERIMENTAL | Patients not requiring a strong cytochrome P450 3A4 (CYP3A4) inhibitor. |
| Dose Escalation Arm B (Monotherapy) | EXPERIMENTAL | 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. |
| Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine) | EXPERIMENTAL | Patients with no prior venetoclax therapy and not requiring a strong CYP3A4 inhibitor for active treatment within 7 days of starting LY3410738. |
| Cohort 1 | EXPERIMENTAL | Patients with relapsed/refractory (R/R) AML harboring an IDH1 R132 mutation who have received a prior IDH inhibitor. |
| Cohort 2 | EXPERIMENTAL | Patients with R/R AML harboring an IDH1 R132 mutation who have not received a prior IDH inhibitor. |
| Cohort 3 | EXPERIMENTAL | Patients with R/R MDS, chronic myelomonocytic leukemia (CMML) or other advanced hematologic malignancy harboring an IDH1 R132 mutation. |
| Cohort 4 | EXPERIMENTAL | Patients with R/R AML, MDS, CMML or other advanced hematologic malignancy harboring IDH2 mutations. |
| Cohort 5 | EXPERIMENTAL | 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. |
| LY3410738 | EXPERIMENTAL | Phase 1 dose escalation - Multiple doses of LY3410738 |
| LY3410738 alone or in combination with gemcitabine and cisplatin or in combination with durvalumab | EXPERIMENTAL | Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab |
| Name | Type | Description |
|---|---|---|
| LY3410738 | DRUG | Oral LY3410738 |
| Venetoclax | DRUG | Oral venetoclax |
| Azacitidine | DRUG | Subcutaneous or intravenous azacitidine |
| Gemcitabine | DRUG | Intravenous gemcitabine |
| Cisplatin | DRUG | Intravenous cisplatin |
| Durvalumab | DRUG | Intravenous durvalumab |
Inclusion Criteria: * Advanced IDH mutant hematologic malignancy including: \-- For Dose Escalation Arm C and Dose Expansion Cohort 5: * Patients with newly diagnosed AML who are 75 years or older or have comorbidities that preclude the use of intensive chemotherapy * Patients with R/R AML (...
LY3410738 is an investigational oral small molecule developed by Eli Lilly and Company for cancers that carry IDH1 or IDH2 mutations. It is being studied in acute myeloid leukemia and cholangiocarcinoma, along with other hematologic malignancies and advanced solid tumors. It remains in clinical development and is not an approved therapy.
LY3410738 is being studied in adults with acute myeloid leukemia that carries IDH1 or IDH2 mutations. The Phase 1 trial NCT04603001 also enrolls patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, and myeloproliferative neoplasms. It is investigational and has not been approved for any indication.
LY3410738 targets mutant IDH1 and IDH2, the isocitrate dehydrogenase genes. Because the drug is designed against these specific mutations, trials enroll only patients whose tumors test positive for an IDH1 or IDH2 alteration, making it a biomarker-selected therapy rather than a broadly applicable agent.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is developing LY3410738. The company sponsors the Phase 1 clinical program evaluating the oral small molecule in IDH-mutant hematologic malignancies and advanced solid tumors.
LY3410738 is in Phase 1 clinical development. Both of its registered studies, NCT04603001 in hematologic malignancies and NCT04521686 in advanced solid tumors, are Phase 1 and are currently listed as active but not recruiting. The drug is investigational and has not received FDA approval.
LY3410738 has two Phase 1 trials. NCT04603001 evaluates oral LY3410738 in advanced hematologic malignancies with IDH1 or IDH2 mutations, including acute myeloid leukemia, and NCT04521686 evaluates it in advanced solid tumors such as cholangiocarcinoma, chondrosarcoma, and glioma. Both are active but no longer recruiting participants.