Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
LY3295668 is an investigational small molecule being studied for the treatment of neoplasms, including solid tumors, neoplasm metastasis, triple negative breast neoplasms, head and neck neoplasms, breast neoplasms, and small cell lung carcinoma. It is currently in Phase 1 clinical development.
LY3295668 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in the oncology therapeutic area.
LY3295668 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with neoplasms.
LY3295668 has been studied in one clinical trial, identified as NCT03092934, titled "A Study of AK-01 (LY3295668) in Solid Tumors." This Phase 1 trial was completed and enrolled 13 participants in Canada, including adults aged 18 years and older.
Yes, LY3295668 is also known as AK-01. The clinical trial NCT03092934, titled "A Study of AK-01 (LY3295668) in Solid Tumors," uses both names to refer to the same investigational drug being developed by Eli Lilly and Company.