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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06295731 | INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC | PHASE2 | ACTIVE NOT_RECRUITING | 410 | — | — | May 14, 2024 | May 1, 2029 | May 8, 2026 | 87 | United States, Australia +11 |
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).
OS is the time from randomization to death due to any cause
| Arm | Type | Description |
|---|---|---|
| INBRX-106 plus pembrolizumab | EXPERIMENTAL | Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3) |
| pembrolizumab monotherapy (+ placebo in phase 3 part) | ACTIVE_COMPARATOR | Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3) |
| Name | Type | Description |
|---|---|---|
| INBRX-106 | DRUG | INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3) |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3) |
Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies. * Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis. ...