Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04148937 | A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer | PHASE1 | COMPLETED | 52 | — | — | Jan 16, 2020 | Jun 20, 2022 | Apr 5, 2024 | 12 | United States, Australia +1 |
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 |