First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04622774|
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: IMGC936||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||245 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936 (Anti-ADAM9 Antibody Drug Conjugate) in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||April 30, 2024|
Single-arm. IMGC936 administered every 3 weeks.
Antibody Drug Conjugate
- During dose escalation measure incidence and severity of Treatment Emergent Adverse Events by CTCAE v5.0 [ Time Frame: From screening to end of study (approximately up to 2 years) for each patient ]Number of treatment emergent adverse events as assessed by CTCAE v5.0
- During dose escalation characterize dose-limiting toxicities (DLTs) [ Time Frame: DLT evaluation period is through cycle 1 (21 days) ]Incidence of DLTs
- During expansion describe the Overall Response Rate for IMGC936 using RECIST v1.1 [ Time Frame: From screening to end of study (approximately up to 2 years) for each patient ]Time to progression of disease using RECIST v1.1
- During dose escalation and expansion to characterize study drug concentration [ Time Frame: 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. ]Study drug concentration
- During dose escalation and expansion to measure the concentration of anti-drug antibody [ Time Frame: 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. ]Anti-drug antibody
- During dose expansion describe the duration of response and progression free survival [ Time Frame: From screening to end of study (approximately up to 2 years) for each patient ]Time to disease progression
- During dose escalation to describe the objective response rate and duration of response [ Time Frame: From screening to end of study (approximately up to 2 years) for each patient ]Time to disease progression
- During dose expansion measure incidence and severity of Treatment Emergent Adverse Events by CTCAE v5.0 [ Time Frame: From screening to end of study (approximately up to 2 years) for each patient ]Number of treatment emergent adverse events as assessed by CTCAE v5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622774
|Contact: ImmunoGen Clinical Operationsfirstname.lastname@example.org|
|United States, Colorado|
|Sarah Cannon Research Institute||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Gerald Falchook, MD 720-754-2610|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: DFCI Clinical Trials Hotline 1-877-DF-TRIAL|
|Contact: Leena Gandhi, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vivek Subbiah, MD 713-563-1930|
|Principal Investigator: Vivek Subbiah, MD|
|Study Director:||CMO ImmunoGen||ImmunoGen, Inc.|