Clinical trial · Interventional
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
NCT04671849CI-TRIAL-00049414terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): Business strategy
Summary
Brief summary (as posted)
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.
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 or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIM1803-1A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- adult patients_Dose 1
- interventionNames
- Drug: SIM1803-1A
- type
- EXPERIMENTAL
- label
- adult patients_Dose 2
- interventionNames
- Drug: SIM1803-1A
- type
- EXPERIMENTAL
- label
- adult patients_Dose 3
- interventionNames
- Drug: SIM1803-1A
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists;Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion;Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month;Adequate hematologic, hepatic, and renal function;Signed informed consent form; Exclusion Criteria: * Any contraindications as listed in the local approved product information;Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible;Pregnancy or lactation;Clinically significant active cardiovascular disease or history of myocardial infarction;Participation in an investigational program with interventions outside of routine clinical practice;Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition;Active uncontrolled systemic bacterial, viral, or fungal infection;Current treatment with a strong CYP3A4 inhibitor or inducer;
References
Publications (0)
Data not yet available
No reference posted for this study.