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IMGC936

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jan 15, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04622774First-in-Human Study of IMGC936 in Participants With Advanced Solid TumorsPHASE1 COMPLETED 56Oct 29, 2020Dec 28, 2023Jan 15, 202513 United States, Italy +1
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Study Endpoints
Primary Endpoints
Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to approximately 3 years

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AEs with onset date between the first dose of IMGC936 and date of the last dose of IMGC936 + 30 days (inclusive) or date of the first anti-cancer therapy, whichever was earlier. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)
Cycle 1 (21 days for Schedule A and 28 days for Schedule B)

DLTs were defined based on TEAEs or abnormal laboratory values that met DLT criteria. Hematologic DLT: Grade 4 neutropenia lasting \>7 days; ≥Grade 3 febrile neutropenia Grade 4 thrombocytopenia; Grade 3 thrombocytopenia associated with bleeding; ≥Grade 3 hemolysis. Non-hematologic DLT: Any ≥Grade 3 non-hematologic event, including Grade 3 ocular symptoms and signs; Grade 2 AEs that were prolonged inordinately; • Hepatic laboratory abnormalities meeting Hy's law criteria; Eye pain or reduction in visual acuity that did not respond to topical ophthalmic therapy. Hepatic DLT: Any elevation of ≥1 transaminases \>8 \* upper limit of normal (ULN); Any Grade 3 elevation of ≥1 transaminases \>5.0-8.0 \* ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Grade 3 elevation of total bilirubin \>5 \* ULN; Any Grade 3 elevation of total bilirubin \>3.0-5.0 \* ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Any event meeting criteria for Hy's law.

Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Up to approximately 3 years

ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

Secondary Endpoints
Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)
Schedule A: Cycle 1 Day 1 (C1D1), C3D1; Schedule B: C1D1, C1D15
Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)
Up to approximately 3 years
Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1
Up to approximately 3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation - Schedule A: IMGC936 0.5 mg/kgEXPERIMENTALParticipants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 1.0 mg/kgEXPERIMENTALParticipants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 2.0 mg/kgEXPERIMENTALParticipants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 4.0 mg/kgEXPERIMENTALParticipants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 5.0 mg/kgEXPERIMENTALParticipants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 6.0 mg/kgEXPERIMENTALParticipants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule A: IMGC936 7.0 mg/kgEXPERIMENTALParticipants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Escalation - Schedule B: IMGC936 2.0 mg/kgEXPERIMENTALParticipants received IMGC936 2.0 mg/kg on Days 1, 8, and 15 of a 28-day cycle for the first 2 cycles. On all subsequent cycles (Cycle 3 and beyond), participants received IMGC936 2.0 mg/kg on Days 1 and 8 of a 28-day cycle.
Dose Expansion - NSCLC: IMGC936 6.0 mg/kgEXPERIMENTALParticipants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Dose Expansion - TNBC: IMGC936 6.0 mg/kgEXPERIMENTALParticipants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.
Interventions
NameTypeDescription
IMGC936DRUGAntibody Drug Conjugate
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous NSCLC, TNBC, CRC, gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available. 1. NSCLC: Partici...

Countries:United StatesItalySpain
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