Clinical trial · Interventional
Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
NCT03696771CI-TRIAL-00056334completedPhase 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)
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NON-breast HER2+ Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NJH395 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NJH395
- description
- Includes non-breast HER2-positive advanced malignancies
- interventionNames
- Drug: NJH395
Primary outcomes (2)
- measure
- Incidence and severity of dose limiting toxicities (DLTs)
- timeFrame
- 21 days
- description
- The time frame will expand to 42 days for the second part of the study
- measure
- Number of participants with Adverse Events
- timeFrame
- 2.5 years
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer * Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 who have progressed or are intolerant to all approved therapies known to confer clinical benefit. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy prior to therapy, and during therapy on this study. Key Exclusion Criteria: * History of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody. * Patients previously treated with TLR 7/8 agonist. * Impaired cardiac function or history of clinically significant cardiac disease * Active, known or suspected autoimmune disease. * Human Immunodeficiency virus (HIV) infection * History of or current interstitial lung disease or pneumonitis Grade 2 or greater. * Discontinued prior checkpoint inhibitor due to a checkpoint inhibitor related toxicity. * Currently receiving medications known to cause Torsades de Pointe that cannot be discontinued 7 days prior to starting treatment Other protocol defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDJanku F, Han SW, Doi T, Amatu A, Ajani JA, Kuboki Y, Cortez A, Cellitti SE, Mahling PC, Subramanian K, Schoenfeld HA, Choi SM, Iaconis LA, Lee LH, Pelletier MR, Dranoff G, Askoxylakis V, Siena S. Preclinical Characterization and Phase I Study of an Anti-HER2-TLR7 Immune-Stimulator Antibody Conjugate in Patients with HER2+ Malignancies. Cancer Immunol Res. 2022 Dec 2;10(12):1441-1461. doi: 10.1158/2326-6066.CIR-21-0722. PMID 36129967