Clinical trial · Interventional
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies
NCT03538028CI-TRIAL-00048021completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Uveal Melanoma Excluded) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Microsatellite Instability (MSI)-High Endometrial Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCAGN02385 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCAGN02385
- description
- Part 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1.
- interventionNames
- Biological: INCAGN02385
Primary outcomes (1)
- measure
- Number of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 12 months
- description
- TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Secondary outcomes (11)
- measure
- Cmax of INCAGN02385
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Disease progression after treatment with available therapies that are known to confer clinical benefit, or intolerant to treatment, or refuse noncurative standard treatment. There is no limit to the number of prior treatment regimens. * Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer, gastric cancer (including stomach and GEJ), esophageal cancer, hepatocellular carcinoma, melanoma (uveal melanoma excluded), Merkel cell carcinoma, mesothelioma, MSI-high colorectal cancer, NSCLC, ovarian cancer, SCCHN, SCLC, RCC, triple-negative breast cancer, and urothelial carcinoma, or alternative immunogenic tumor types with medical monitor approval. Participants with DLBCL may participate in Part 2 of the study. * Presence of measureable disease based on RECIST v1.1 for solid tumors or the Lugano classification for DLBCL. * Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies. * Eastern Cooperative Oncology Group performance status 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters outside the protocol-defined range. * Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before study Day 1. * Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * Receipt of a live vaccine within 30 days of planned start of study drug. * Active autoimmune disease that required systemic treatment in the past. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. See protocol-defined exceptions. * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * Active infection requiring systemic therapy. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of HIV (HIV 1/2 antibodies). * Prior treatment with an anti-LAG-3 antibody for any indication.
References
Publications (0)
Data not yet available
No reference posted for this study.