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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04180215 | A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers | PHASE1 | COMPLETED | 198 | — | — | Dec 11, 2019 | Jan 9, 2025 | Sep 15, 2025 | 34 | United States, Netherlands +1 |
Determine the recommended Phase II dose in terms of safety and tolerability for intravenously administered HB-201, and intravenously administered HB-202 by assessing drug limiting toxicities.
Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using Response Evaluation Criteria in Solid Tumors (RECIST) to determine objective response rate (ORR).
| Arm | Type | Description |
|---|---|---|
| Ph I, Group 1 and Group 2 | EXPERIMENTAL | Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy. |
| Ph I, Group 3 and Group 4 | EXPERIMENTAL | Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy. |
| Ph II, Group B | EXPERIMENTAL | Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care. |
| Ph II, Group E | EXPERIMENTAL | Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care. |
| Ph II, Group F | EXPERIMENTAL | Patients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care.. |
| Ph I, sub-study | EXPERIMENTAL | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy |
| Name | Type | Description |
|---|---|---|
| HB-201 intravenous administration. | DRUG | Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort). |
| HB-202 intravenous administration alternating with HB-201 intravenous administration. | DRUG | Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort). |
| HB-201 intravenous administration + standard of care regimen including pembrolizumab. | DRUG | Dose Expansion |
| HB-202 / HB-201 alternating intravenous administration + pembrolizumab. | DRUG | Dose Expansion |
| HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab. | DRUG | Dose Expansion |
| HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C) | DRUG | Dose escalation; 10 patients |
Inclusion Criteria All Patients: * Documentation of confirmed HPV 16+ cancer via genotype testing. * ≥ 1 measurable lesion by imaging for tumor response following RECIST * ECOG performance status of 0 to 1. * Prior curative radiation therapy and prior focal palliative completed per protocol-specif...