Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMGC936 · 1 trial · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation - Schedule A: IMGC936 0.5 mg/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants 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/kg | EXPERIMENTAL | Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter. |
| Name | Type | Description |
|---|---|---|
| IMGC936 | DRUG | Antibody Drug Conjugate |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
IMGC936 is an investigational therapy being studied for the treatment of advanced solid tumors. It is not approved for any indication and remains in clinical development. The Phase 1 first-in-human study enrolled adults with advanced solid tumors across sites in the United States, Italy, and Spain.
IMGC936 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the agent in advanced solid tumors.
IMGC936 is in Phase 1 development. The single registered trial, NCT04622774, was a first-in-human Phase 1 study in participants with advanced solid tumors. That study is listed as completed, and no active trials are currently registered for the asset.
IMGC936 has been evaluated in one registered clinical trial, NCT04622774, titled a First-in-Human Study of IMGC936 in Participants With Advanced Solid Tumors. The Phase 1 trial enrolled 56 participants aged 18 years and older across the United States, Italy, and Spain, and it is listed as completed.
IMGC936 is not approved and remains an investigational agent in clinical development. Its only registered study, the Phase 1 trial NCT04622774 in advanced solid tumors, has been completed. No regulatory approval has been granted for this asset.