Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HB-201 intravenous administration.
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 administration refers to the intravenous dosing of HB-201, an investigational therapy developed by HOOKIPA Pharma Inc. for HPV-related squamous cell carcinoma. It was studied in a Phase 1/2 clinical trial in patients with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers.
HB-201 administration is being studied for HPV-related squamous cell carcinoma, including HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers. The Phase 1/2 trial enrolled 198 patients across the United States, Netherlands, and Spain. It is investigational and has not been approved for commercial use.
HB-201 administration is being developed by HOOKIPA Pharma Inc., which trades on the Nasdaq under the ticker HOOK. The company sponsored the Phase 1/2 clinical trial evaluating the intravenous administration of HB-201 in patients with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers.
HB-201 administration is in Phase 1 development. The single clinical trial, NCT04180215, was a Phase 1/2 study that has been completed. It enrolled 198 patients and was conducted in the United States, Netherlands, and Spain. HB-201 administration remains investigational and is not FDA approved.
HB-201 administration was evaluated 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. The trial enrolled 198 patients, was controlled, was not randomized or double blinded, and has been completed.
Yes, HB-201 administration and HB-201 intravenous administration refer to the same investigational therapy from HOOKIPA Pharma Inc. The intravenous route describes how HB-201 is given to patients. Both names point to the same Phase 1/2 program studied in NCT04180215 for HPV-related squamous cell carcinoma.