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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 administration is an investigational therapy being studied for the treatment of HPV-Related Squamous Cell Carcinoma, including HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
HB-201 administration is being developed by HOOKIPA Pharma Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol HOOK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with HPV-related cancers.
HB-201 administration is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The therapy is being studied in a clinical trial to assess its safety, tolerability, and potential efficacy in treating HPV-Related Squamous Cell Carcinoma.
HB-201 administration is being studied in a Phase 1/2 clinical trial with the identifier NCT04180215. This trial is titled 'A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers' and has been completed. The trial enrolled 198 participants across the United States, Netherlands, and Spain.
HB-201 administration refers to the administration of the investigational drug HB-201. The clinical trial NCT04180215 evaluates HB-201 as a therapeutic agent. While 'HB-201 administration' is the term used in the data, it is the same drug entity being tested for HPV-related cancers.