Phase 2
Completed N=56
First-in-Human Study of IMGC936 in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Source: ClinicalTrials.gov NCT04622774 ↗
Enrolled (actual)
56
Serious AEs
28.6%
Results posted
Jan 2025
Primary outcomePrimary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 3; 3; 3; 3 Participants
Summary
This study is a Phase 1/2, first-in-human, open-label, dose-escalation, and expansion study designed to characterize the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of IMGC936 administered by intravenous (IV) infusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
3; 3; 3; 3; 3; 10 | — |
| PRIMARY 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) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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) |
0; 0 | — |
| SECONDARY Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax) |
14.17; 22.21; 56.69; 107.2; 114.8; 149.5 | — |
| SECONDARY Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA) |
3; 1; 1; 0; 1; 2 | — |
| SECONDARY Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 |
2.7; 1.2 | — |
| SECONDARY Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation |
13; 6; 4; 2; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines.
- TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies.
- CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
- Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
- Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
- Either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) obtained within 28 days of Cycle 1 Day 1 (C1D1).
- Dose escalation: Participants may have non-measurable or measurable disease
- Dose expansion: Participants must have measurable disease
- Age ≥ 18 years old.
- Archival formalin-fixed paraffin-embedded (FFPE) tissue must be available. Participants may undergo a fresh tumor biopsy using a low risk, medically routine procedure to obtain a specimen for testing if a tumor sample is not available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. If ECOG performance status is an inappropriate performance measurement for participant enrollment (for example, chronically non-ambulatory), then Karnofsky performance status must be ≥ 70.
- Life expectancy ≥ 12 weeks.
- Acceptable laboratory parameters as follows:
- Platelet count ≥ 75 × 1000/microliter (μL) without transfusion within 28 days prior to initiation of study drug.
- Absolute neutrophil count ≥ 1.5 × 1000/μL in the absence of any growth factor support within 21days prior to initiation of study drug.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤ 5 × ULN.
- Total bilirubin ≤ 1.5 × ULN, except participants with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits.
- Estimated glomerular filtration rate (eGFR) >30 milliliters (mL)/ minute (min)/1.73 square meter (m^2) or an estimated creatinine clearance of >30 mL/min.
- Urinalysis protein and white occult blood cells within normal limits.
- Negative serum pregnancy test for females of childbearing potential (FOCBP).
- FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and between menarche and 1-year post menopause, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug administration. Female participants must abstain from egg donation during the study.
- FOCBP and male participants with partners of FOCBP must agree to use highly effective methods of contraception, from the time of consent through 28 weeks after discontinuation of study drug administration. Male participants must abstain from sperm donation during the study.
- FOCBP is not pregnant or breastfeeding, or a male participant is not expecting to father children within the projected duration of the study, starting with screening visit through 28 weeks after the last dose of study drug.
Exclusion Criteria
- Active central nervous system (CNS) disease within the last 6 months.
- Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic
Data sourced from ClinicalTrials.gov (NCT04622774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.