This study is a Phase 1, first-in-human, open-label, dose-escalation study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of IMGC936 administered by intravenous (IV) infusion.
Description: Number of treatment emergent adverse events as assessed by CTCAE v5.0Measure: Incidence and severity of Treatment Emergent Adverse Events by CTCAE v5.0 Time: From screening to end of study (approximately up to 2 years) for each patient
Description: Incidence of DLTsMeasure: To characterize dose-limiting toxicities (DLTs) Time: DLT evaluation period is through cycle 1 (21 days)
Description: Study drug concentrationMeasure: To characterize study drug concentration Time: There are 9 blood draw collection time points at Cycles 1 and 3, 3 blood draw time points at Cycles 2,4,5 and 6, and collection at every 3 cycles after cycle 6 until end of study (approximately up to 2 years). Each cycle is 21 days.
Description: Anti-drug antibodyMeasure: To measure the concentration of anti-drug antibody Time: There are 2 collection time points at Cycles 1 and 3, 1 collection time point at Cycles 2, 4, 5 and 6, and and collection at every 3 cycles after cycle 6 until end of study (approximately up to 2 years). Each cycle is 21 days.
Single Group Assignment
There is one SNP
Tumor assessments are performed every 6 weeks (Q6W) for the first 6 months on study drug then every 12 weeks (Q12W). --- Q12W ---
If feasible, participants who discontinue study drug for reasons other than progressive disease (PD) (e.g., toxicity) should continue to undergo tumor assessments Q12W as post-treatment follow up until evidence of PD, initiation of another anticancer therapy, withdrawal of consent, LTFU, death, or end of study. --- Q12W ---