Actively Recruiting
A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities
Led by Cullgen (Shanghai),Inc · Updated on 2026-02-06
42
Participants Needed
6
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the safety of drug CG001419. It also learn if drug CG001419 works to treat in locally advanced/metastatic adult solid tumours with NTRK gene fusions, NTRK gene point mutations, and NTRK gene amplification or over expression. The main questions it aims to answer are: Phase1:To determind the Maximum Tolerated Dose (MTD) and/or Phase 2 Recommended Dose for Phase 2 (RP2D) of CG001419 administered orally to adult subjects with locally advanced/metastatic solid tumours. To establish the safety and tolerability profile of CG001419. Phase2:To evaluate the efficacy of CG001419 in adult subjects with locally advanced or metastatic solid tumours harbouring oncogenic NTRK fusions, mutations, amplifications or over expression. Participants will Receive treatment with CG001419 until disease progression.
CONDITIONS
Official Title
A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at informed consent
- Estimated survival of at least 3 months
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors with no available or failed standard therapy
- For dose escalation phase: priority given to patients with tumors harboring oncogenic NTRK/TRK alterations
- For dose expansion and indication expansion phases: confirmed oncogenic NTRK/TRK alterations by tumor tissue or blood testing
- Enrolled into cohorts based on NTRK fusion status and prior TRK inhibitor treatment
- At least one measurable target lesion per RECIST v1.1 or other specified criteria
- Patients with CNS tumors or brain metastases must be clinically stable and meet corticosteroid use requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Agreement to provide genetic testing results or samples for NTRK status confirmation
- Adequate organ function confirmed by laboratory tests within 7 days prior to first dose
- Recovery to Grade 1 or less toxicity from prior therapies except alopecia and stable chronic conditions
- Ability to swallow tablets
- Not pregnant or lactating; females of childbearing potential must have a negative pregnancy test
- Agreement to use effective contraception or abstinence during treatment and for 90 days after last dose
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Age below 18 years
- Estimated survival less than 3 months
- Tumors resectable or without failure/intolerance to standard therapies
- Lack of confirmed oncogenic NTRK/TRK alterations for certain study phases
- Unstable CNS tumors or brain metastases not meeting clinical stability or corticosteroid requirements
- ECOG performance status greater than 2
- Inability or unwillingness to provide genetic testing or tumor/blood samples for NTRK confirmation
- Inadequate organ function per laboratory tests
- Unresolved toxicities from prior anticancer therapy above Grade 1 except alopecia and stable chronic conditions
- Pregnancy or lactation
- Inability to swallow tablets
- Refusal or inability to comply with study visits, treatments, or procedures
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Trial Site Locations
Total: 6 locations
1
The Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
4
The Sir Run Run Shaw Hospital, Affiliated to Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
5
Zhejiang Provincial Cancer Hospital
Hangzhou, China
Actively Recruiting
6
Shanxi Provincial Cancer Hospital
Taiyuan, China
Actively Recruiting
Research Team
X
Xiangyu Jin, MS
CONTACT
Q
Qiao Yi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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