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New treatment option for Solid Tumors Harboring NTRK Fusion
Official title A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities
ClinicalTrials.gov ID: NCT07394374
What this study is testing
What is CG001419 tablets?
CG001419 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumors harboring ntrk fusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 when signing the informed consent form, regardless of gender.
- The estimated survival time is ≥3 months.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that have failed, are intolerant to, or have no...
- Dose Escalation Phase: While testing for NTRK/TRK status is not mandatory, enrollment priority will be accorded to patients whose tumors harbor...
- The Indication Expansion Phase will enroll people into the following three cohorts, with respective entry criteria: Cohort 1: people with a confirmed...
See the full eligibility criteria
- Age ≥18 when signing the informed consent form, regardless of gender.
- The estimated survival time is ≥3 months.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that have failed, are intolerant to, or have no available standard therapy.
- Dose Escalation Phase: While testing for NTRK/TRK status is not mandatory, enrollment priority will be accorded to patients whose tumors harbor oncogenic NTRK/TRK alterations. Dose Expansion and Indication Expansion...
- The Indication Expansion Phase will enroll people into the following three cohorts, with respective entry criteria: Cohort 1: people with a confirmed oncogenic NTRK fusion who have not received prior treatment with...
- Must have at least one measurable target lesion according to RECIST v1.1. (For patients with HCC, mRECIST v1.1 should be used; for patients with primary CNS tumors or brain metastases, RANO criteria may be used.)...
- people with primary CNS tumors or brain metastases must be clinically stable for at least 2 weeks after prior treatment, with no requirement for corticosteroids, or be on a stable or decreasing dose of ≤4 mg/day of...
- The physical fitness status (PS) score of the American Eastern Cancer Cooperative Group (ECOG) is ≤ 2.
- The subject agrees to provide either the results of genetic testing from a tumor tissue specimen obtained within 1 year after the completion of the prior therapy from a laboratory capable of ensuring quality results, or...
- Adequate organ function must be confirmed by laboratory test results within 7 days prior to the first dose of study drug, meeting all the following criteria: 1)Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, platelet count...
- Female people of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test (for beta-human chorionic gonadotropin [β-hCG]) at screening.
- A female subject is considered NOT to be of childbearing potential if she meets at least one of the following criteria: natural amenorrhea for ≥ 12 consecutive months with corresponding clinical characteristics (e.g...
- Male people with female partners of childbearing potential and female people of childbearing potential must agree to use highly effective contraception or practice abstinence during the treatment period and for 90 days...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Taiyuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Chengdu, China; Guangzhou, China; Hangzhou, China; Taiyuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.