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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06257264 | A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors | PHASE1 | RECRUITING | 258 | — | — | Mar 11, 2024 | Jul 1, 2028 | May 11, 2026 | 24 | United States, Australia +4 |
Number of participants with treatment-emergent AEs and SAEs.
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
RDFE of BG-68501 alone will be determined based upon the MTD or MAD.
RDFE of BG-68501 in combination with fulvestrant and BGB-43395 will be determined based upon the MTD or MAD.
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). CR and PR that is confirmed by repeat assessments, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1 Part A: Dose Escalation and Safety Expansion (BG-68501 Monotherapy) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy. |
| Part 1 Part B: Dose Escalation (BG-68501 + Fulvestrant) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant. |
| Part 1 Part C: Dose Escalation and Safety Expansion (BG-68501 + Fulvestrant + BGB-43395) | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant and BGB-43395. |
| Part 1: Food Effect Evaluation | EXPERIMENTAL | Participants will receive BG-68501 at a dose level that is determined safe and tolerable to evaluate food effect. Food effect may also be evaluated for BG-68501 in combination with fulvestrant. |
| Part 2: Dose Expansion | EXPERIMENTAL | The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant and BGB-43395) from Part 1 will be evaluated in selected tumor cohorts. |
| Name | Type | Description |
|---|---|---|
| BG-68501 | DRUG | Planned doses administered orally. |
| Fulvestrant | DRUG | Standard dose administered via intramuscular injection. |
| BGB-43395 | DRUG | Planned doses administered orally. |
Part 1 (Dose Escalation) Inclusion Criteria: * Monotherapy Cohorts: Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CDK2 dependency including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian cancer (...