First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors

Summary

Objectives

This is an open-label, dose-escalation, and expansion study to determine the Maximum
Tolerated Dose (MTD) and select the recommended phase 2 dose. Dose escalation follows a
conventional 3+3 design; successive cohorts of 3 to 6 participants each will be evaluated in
sequential escalating doses of single-agent IMGC936. Upon completion of the dose-escalation
phase of the study, following determination of the recommended Phase 2 dose (RP2D), up to 5
expansion cohorts may be opened in tumor types selected from those enrolled in dose
escalation.

Participants with relapsed or refractory, unresectable locally advanced or metastatic solid
tumors including non-squamous non-small cell lung cancer (NSCLC), triple-negative breast
cancer (TNBC), colorectal cancer (CRC), gastroesophageal cancer, or pancreatic cancer will be
enrolled.

IMGC936 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 and every
subsequent 21-day cycle thereafter, at the assigned dose for each cohort during dose
escalation, and at the RP2D for expansion. Infusion duration will vary depending on dose and
participant tolerability.

Sentinel dosing will be used for the first 2 dose levels of dose escalation. The first
administration of IMGC936 in participants at the first 2 dose levels of dose escalation will
be staggered by at least 48 hours. The dose-limiting toxicity (DLT) evaluation period is 21
days. Participants may continue on study drug until disease progression, adverse event (AE)
requiring discontinuation, DLT during evaluation window, pregnancy, death, investigator
decision, lost to follow up (LTFU), major protocol deviation requiring discontinuation,
withdrawal of consent, or sponsor, investigator or regulatory agency terminates the study.

Tumor assessments are performed every 6 weeks (Q6W) while on study drug then every 12 weeks
(Q12W). Tumor assessments continue until discontinuation criteria are met. 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. Post-treatment follow up also includes following ongoing
treatment emergent adverse events (TEAEs) until the event has resolved to baseline grade, the
event is assessed by the investigator as stable, initiations of another anticancer therapy,
withdrawal of consent, LTFU, death, or it has been determined that study drug or
participation is not the cause of the AE.