Name | Type | Description | Interventions |
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Ph I, Group 1 | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. | - HB-201 intravenous administration.
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Ph I, Group 2 | Experimental | Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. | - HB-201 intratumoral administration for first dose, followed by HB-201 intravenous administration for subsequent doses.
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Ph I, Group 3 | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. | - HB-202 intravenous administration alternating with HB-201 intravenous administration.
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Ph I, Group 4 | Experimental | Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. | - HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses.
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Ph II, Group A | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. | - HB-201 intravenous administration at recommended phase II dose and determined schedule.
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Ph II, Group B | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care and are eligible to receive immune checkpoint inhibitor as part of standard of care. | - HB-201 intravenous administration at recommended phase II dose and determined schedule + immune checkpoint inhibitor per standard of care.
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Ph II, Group C | Experimental | Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. | - HB-201 intratumoral administration for first dose followed by HB-201 intravenous administration for subsequent doses at recommended phase II dose and determined schedule.
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Ph II, Group D | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. | - HB-202 intravenous administration alternating with HB-201 intravenous administration at recommended phase II doses and determined schedule.
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Ph II, Group E | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care and are eligible to receive immune checkpoint inhibitor as part of standard of care. | - HB-202 intravenous administration alternating with HB-201 intravenous administration at recommended phase II doses and determined schedule + immune checkpoint inhibitor.
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Ph II, Group F | Experimental | Patients with HPV 16+ cancers with a safe and accessible tumor site amenable for IT administration who had tumor progression or recurrence on standard of care therapy. | - HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses at recommended phase II dose.
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Ph I, Group 5 | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy. | - HB-201 intravenous administration for a limited number of dose administration.
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Ph I, Group 6 | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy | - HB-202 intravenous administration alternating with HB-201 intravenous administration for a limited number of dose administration
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Ph I, sub-study | Experimental | Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy | - HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)
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