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Adjusted LOA
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Also known as AK-01, Erbumine
LY3295668 · 1 trial · 7 indications
Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1.
Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| 25 milligrams (mg) LY3295668 (Phase 1) | EXPERIMENTAL | 25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles. |
| 50 mg LY3295668 (Phase 1) | EXPERIMENTAL | 50 mg LY3295668 BID administered orally in 21-day cycles. |
| 75 mg LY3295668 (Phase 1) | EXPERIMENTAL | 75 mg LY3295668 BID administered orally in 21-day cycles. |
| 25 mg LY3295668 (Phase 2) | EXPERIMENTAL | 25 mg LY3295668 BID administered orally in 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| LY3295668 | DRUG | Oral capsules |
Inclusion Criteria: * Have received at least 1 but no more than 4 prior systemic therapies * Have adequate organ function * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have estimated life expectancy greater than or equal to (≥)12 weeks * Have fully r...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
LY3295668 is an investigational small molecule developed by Eli Lilly and Company for the treatment of neoplasms, including solid tumors. It is an oncology candidate that has been studied in a Phase 1 clinical trial. It is not an approved therapy and remains in clinical development.
LY3295668 has been studied in adults with neoplasms, including solid tumors, neoplasm metastasis, triple negative breast neoplasms, head and neck neoplasms, breast neoplasms, and small cell lung carcinoma. The trial enrolled patients 18 years and older and was conducted in Canada.
LY3295668 is developed by Eli Lilly and Company, which trades under the ticker LLY. The company sponsored the Phase 1 study of the compound in solid tumors. Eli Lilly is the sole developer named for this asset.
LY3295668 is in Phase 1 development. The single registered trial, NCT03092934, was a Phase 1 study that has been completed. The drug is investigational and has not been approved for any indication.
LY3295668 was evaluated in one clinical trial, NCT03092934, titled A Study of AK-01 (LY3295668) in Solid Tumors. It was a Phase 1, controlled study that enrolled 13 participants across sites in Canada and is now completed. No active trials are ongoing.
Yes, LY3295668 is also known as AK-01. The Phase 1 trial NCT03092934 was titled A Study of AK-01 (LY3295668) in Solid Tumors, listing both names for the same investigational compound. Searches for either name refer to the same Eli Lilly oncology asset.