Clinical trial · Interventional
TR1801-ADC in Patients With Tumors That Express c-Met
A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met
NCT03859752CI-TRIAL-00069850suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Financial funds were withdrawn by investors and study was stopped
Summary
Brief summary (as posted)
First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TR1801-ADC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TR1801-ADC
- description
- Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
- interventionNames
- Biological: TR1801-ADC
Primary outcomes (2)
- measure
- Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
- timeFrame
- 4 years
- description
- Number of participants with treatment-related adverse events
- measure
- Establish maximum tolerated dose
- timeFrame
- 3.5 years
- description
- Number of participants with protocol-defined dose-limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Compliance with all study procedures and visits to the clinical research site * Locally advanced or metastatic disease that is not amenable to definitive therapy * Histologically confirmed diagnosis of a solid tumor which expresses c-Met * Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type * Measurable baseline disease as defined by RECIST Version 1.1 * ECOG Performance Status 0-1 * Body weight within 40 and 150 kg * Clinical laboratory values with the limits as defined by the protocol * Not pregnant or breast feeding * Males and women of child-bearing potential must agree to use an effective method of contraception Exclusion Criteria: * Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures * Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment * Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for \<2 weeks * Unresolved adverse events \>= Grade 2 from prior anticancer therapies * Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study. * Uncontrolled hypertension, unstable angina, or NYHA Class III/IV heart failure * History of capillary leak syndrome * Corticosteroid intolerance * History of anasarca * Untreated or uncontrolled bacterial, viral or fungal infection * HIV infection or active infection with hepatitis B or C * Significant liver disease * History of alcoholism or current alcoholism * Signs of significant portal hypertension * Significant kidney disease within 2 years * Active or unstable gallstone disease * Prior treatment with a c-Met targeted agent * Prior hypersensitivity reaction to treatment with another monoclonal antibody * QTcF \>=470 ms * Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment * Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.