Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3410738 · 4 trials · 9 indications
PK: AUC0-tlast of LY3410738 Tablets Versus Capsules
PK: AUC0-∞ of LY3410738 Tablets Versus Capsules
PK: Cmax of LY3410738 Tablets Versus Capsules
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
For Dose Escalation
For Dose Expansion
| Arm | Type | Description |
|---|---|---|
| Group 1: Tablet versus Capsule | EXPERIMENTAL | Treatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing. |
| Group 2: Food Effect Comparison Group | EXPERIMENTAL | Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. |
| Group 3: Potential of Hydrogen (pH) Effect Fasted Group | EXPERIMENTAL | Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration. |
| Group 4: pH Effect Fed Group | EXPERIMENTAL | Treatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal. |
| Cohort 1 (Treatment A): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
| Cohort 2 (Treatment B): LY3410738 | PLACEBO_COMPARATOR | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
| Cohort 3 (Treatment C): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 4 (Treatment D): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 5 (Treatment E): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 6 (Treatment F): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Cohort 7 (Treatment G): LY3410738 | EXPERIMENTAL | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| 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 | Administered orally. |
| Esomeprazole | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| Venetoclax | DRUG | Oral venetoclax |
| Azacitidine | DRUG | Subcutaneous or intravenous azacitidine |
| Gemcitabine | DRUG | Intravenous gemcitabine |
| Cisplatin | DRUG | Intravenous cisplatin |
| Durvalumab | DRUG | Intravenous durvalumab |
Inclusion Criteria: * Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive. * Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign m...
LY3410738 is an investigational small molecule being studied for the treatment of cancers with IDH1 or IDH2 mutations, including acute myeloid leukemia (AML), cholangiocarcinoma, and other advanced solid tumors and hematologic malignancies. It is currently in Phase 1 clinical trials and is not yet approved by the FDA.
LY3410738 targets IDH, which stands for isocitrate dehydrogenase, a gene that can be mutated in certain cancers. By targeting IDH1 and IDH2 mutations, the drug aims to interfere with cancer cell growth. It is being studied in patients whose tumors carry these specific genetic alterations.
LY3410738 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for oncology indications.
LY3410738 is in Phase 1 clinical trials. It is an investigational drug, meaning it has not been approved by regulatory authorities such as the FDA. All of its clinical studies are early-stage, focusing on safety, tolerability, and dosing in patients with IDH-mutated cancers.
LY3410738 has been studied in several Phase 1 trials. NCT04521686 is an active trial in advanced solid tumors with IDH1 or IDH2 mutations. NCT04603001 is an active trial in hematologic malignancies like AML. NCT06181045 and NCT06181084, both completed, evaluated the drug in healthy participants.
LY3410738 is a distinct investigational drug developed by Eli Lilly. It targets IDH1 and IDH2 mutations, similar to other IDH inhibitors, but it is a unique chemical entity. No alternative names for LY3410738 have been disclosed in clinical trial registrations.