The study involves dose escalation to determine the toxicity profile of HCW9302 and to designate a dose level for the Phase 2 expansion phase (RP2D).
Up to five HCW9302 dose levels will be evaluated. A step-down dose level (level -1) will be provided in the event that unacceptable toxicity is encountered at the planned initial dose level. In the first stage of the study, HCW9302 will be administered subcutaneously as a single dose. Depending on the results of the single ascending dose stage, a multidose study of HCW9302 administered subcutaneously every 28 days for 4 consecutive treatments will be considered.
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Timeline varies based on campaign performance and audience targeting.