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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04486352 | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer | PHASE1 | RECRUITING | 148 | — | — | Oct 20, 2021 | Oct 1, 2027 | Apr 1, 2026 | 21 | United States |
AFT-50A Protocol: Overall response rate for each biomarker cohort is defined as the proportion of participants achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from AFT50A Protocol: Tumor assessments per RECIST v1.1.
AFT-50B Protocol: Progression free survival rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Atezolizumab and Bevacizumab Cohort - Closed to Accrual | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with no specified gene signatures will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Atezolizumab and Ipatasertib Cohort - Closed to Accrual | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with PIK3CA/AKT1/PTEN-altered tumors will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Atezolizumab and Talazoparib Cohort | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that have a ≥16%genomic loss of heterozygosity (LOH) will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with an amplification of ERBB2/HER2 will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Atezolizumab and Tiragolumab Cohort - Closed to Accrual | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumor type MSI-H and/or tTMB \>=10 mut/mb will be assigned to this cohort. Twenty participants will be enrolled initially. Once twenty participants are enrolled, the cohort may be expanded if a positive signal is shown. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Inavolisib and Letrozole Cohort | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with PIK3CA activating mutations in the absence of PTEN loss-of-function alterations or AKT1 activating mutations will be assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Giredestrant and Abemaciclib | EXPERIMENTAL | Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that are RB1 intact with a local grade 1-2 estrogne receptor positive (ER+) are assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab - 28 Day Cycle | DRUG | Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle. |
| Bevacizumab | DRUG | Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle. |
| Ipatasertib | DRUG | Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle. |
| Talazoparib | DRUG | Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle. |
| Trastuzumab emtansine | DRUG | Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle. |
| Tiragolumab | DRUG | Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle. |
| Atezolizumab - 21 Day Cycle | DRUG | Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle. |
| Inavolisib | DRUG | Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle. |
| Letrozole | DRUG | Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle. |
| Giredestrant | DRUG | Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle. |
| Abemaciclib | DRUG | Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle. |
Key Inclusion Criteria: * Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given i...