Clinical trial · Interventional
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor
A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.
NCT04689100CI-TRIAL-00049188unknownPhase 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)
This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort
- description
- Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
- interventionNames
- Drug: JMT101
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort
- description
- Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
- interventionNames
- Drug: JMT101
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type. * At least 1 measurable lesion according to RECIST 1.1; * ECOG score 0 or 1; * Stable for more than 14 days of brain metastasis or spinal cord compression. Exclusion Criteria: * Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment. * The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment. * Known hypersensitivity to any ingredient of JMT101 or their excipients; * Major surgery within prior 4 weeks of first treatment. * Receiving an investigational product in another clinical study within 4 weeks; * History of serious systemic diseases; * Pregnancy or lactating wo
References
Publications (0)
Data not yet available
No reference posted for this study.