Clinical Trial Details
A Phase 1 First-in-Human Study of SEZ6-Directed Antibody Drug Conjugate HWK-206 in Participants with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Overview
Primary Objective:
Dose Escalation Phase 1a (Dose escalation and Backfill)
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To evaluate the safety, tolerability, and DLTs of HWK-206 as monotherapy in participants with ES-SCLC.
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To identify the MTD or MAD and RDE(s)a of HWK-206 in participants with ES-SCLC.
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To identify the MTD or MAD and RDE(s)a of HWK-206 in participants with ES-SCLC.
Phase 1b (Dose Expansion)
- To evaluate the safety and tolerability of HWK-206 at the selected RDE(s)a determined from Phase 1a in participants with ES-SCLC to determine the RP2Da.
Phase 1b (Extension)
To evaluate the safety, tolerability, and efficacy (RECIST Version 1.1a) of HWK-206 at the defined RP2Db in participants with ES-SCLC.
Secondary Objectives:
Dose Escalation Phase 1a (Dose escalation and Backfill)
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To characterize the single- and multiple-dose PK of HWK-206 across its relevant circulating analytes (HWK-206, TAb, CPT116, and CPT119.
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To assess ADA against HWK-206.
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Toevaluate preliminary antitumor activity of HWK-206 in participants with ES-SCLC by RECIST Version 1.1.
Phase 1b (Dose Expansion)
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To evaluate preliminary antitumor activity of HWK-206 at the selected RDE(s) a determined from Phase 1a, in participants with ES-SCLC by RECIST Version 1.1b.
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To characterize the single- and multiple-dose PK of HWK-206 across its relevant circulating analytes (HWK-206, TAb, CPT116, and CPT119.
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To assess ADA against HWK-206.
Phase 1b (Extension)
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To characterize the single- and multiple-dose PK of HWK-206 across its relevant circulating analytes (HWK-206, TAb, CPT116, and CPT119.
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To assess ADA against HWK-206.
Exploratory Objectives:
Dose Escalation Phase 1a (Dose escalation and Backfill)
- To explore potential predictive biomarkers of response.
Phase 1b (Dose Expansion)
To explore changes in potential predictive biomarkers of response.
Phase 1b (Extension)
To explore changes in potential predictive biomarkers of response.