Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3475070 · 1 trial · 1 indication
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0: * Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration. * Grade ≥3 febrile neutropenia * Grade ≥3 anemia requiring a blood transfusion * Other Grade ≥4 toxicities, excluding few nonhematologic Toxicities * Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade \>2 toxicities causing a delay of LY3475070 study treatment \>14 days during the 28-day DLT observation period.
| Arm | Type | Description |
|---|---|---|
| Phase 1a Cohort A LY3475070 (dose escalation) | EXPERIMENTAL | Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. |
| Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation) | EXPERIMENTAL | Participants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. |
| Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion) | EXPERIMENTAL | LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort C2 LY3475070 (dose expansion) | EXPERIMENTAL | LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion) | EXPERIMENTAL | LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort D2 LY3475070 (dose expansion) | EXPERIMENTAL | LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) | EXPERIMENTAL | LY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Name | Type | Description |
|---|---|---|
| LY3475070 | DRUG | Administered orally |
| Pembrolizumab | DRUG | Administered IV |
Inclusion Criteria: * Participants must have certain types of cancer such as breast cancer, pancreatic cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and ovarian cancer * Participants must have stopped other forms of treatment for the cancer * In the expansion cohorts ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
LY3475070 is an investigational small molecule being studied for the treatment of advanced cancer. It is being developed by Eli Lilly and Company as a potential therapy for patients with advanced solid tumors. The drug is currently in clinical development and has not been approved by regulatory authorities.
LY3475070 targets CD73, an enzyme involved in the production of adenosine in the tumor microenvironment. By inhibiting CD73, the drug aims to reduce immunosuppressive adenosine levels, potentially enhancing the body's immune response against cancer cells. This mechanism is being evaluated in combination with other cancer therapies.
LY3475070 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. Eli Lilly is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced cancer.
LY3475070 is in Phase 1 clinical development. The drug is being studied in an early-stage clinical trial to assess its safety, tolerability, and preliminary efficacy in patients with advanced cancer. It is an investigational agent and has not yet received regulatory approval for commercial use.
LY3475070 has been studied in one clinical trial with the identifier NCT04148937. This Phase 1 study evaluated LY3475070 alone or in combination with pembrolizumab in participants with advanced cancer. The trial was conducted in the United States, Australia, and the United Kingdom, enrolling 52 participants aged 18 years and older.
LY3475070 is a unique investigational compound developed by Eli Lilly and Company. It is not known to be the same as any other marketed drug. The drug is being studied as a monotherapy and in combination with pembrolizumab, an approved immunotherapy, for the treatment of advanced cancer.