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HB-201 administration. · 1 trial · 1 indication
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...
HB-201 is an investigational therapy being studied for the treatment of HPV-related squamous cell carcinoma, specifically in patients with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers. It is currently in Phase 1 clinical development.
HB-201 is being developed by HOOKIPA Pharma Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol HOOK. The drug is currently in Phase 1 clinical trials for HPV-related squamous cell carcinoma.
HB-201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 1/2 trial that has been completed, with a total enrollment of 198 participants.
HB-201 is being studied in clinical trial NCT04180215, titled 'A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers.' This trial has been completed and enrolled 198 participants across the United States, Netherlands, and Spain.
HB-201 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for HPV-related squamous cell carcinoma. The clinical trial for HB-201 has been completed, but the drug has not received regulatory approval.