Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CG001419 tablets
CG001419 · 2 trials · 6 indications
Safety and tolerability based on adverse events (AEs)
Defined as the highest dose level at which no more than 1/6 of the subjects experience dose-limiting toxicity(DLT) during the DLT assessment period.
Defined as the optimal Phase II dosing regimen explored and selected based on the comprehensive evaluation of the drug's safety, tolerability, pharmacokinetic profile, and efficacy.
According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, evaluate the safety and tolerability of CG001419 at different doses in the treatment of advanced solid tumors.
The proportion of subjects whose best overall response is Complete Response(CR) or Partial Response(PR) in the study assessed by Independent Central Review(IRC) according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| CG001419 | EXPERIMENTAL | Part A: Single ascending dose cohorts; food effect cohort; Part B: Multiple ascending dose cohorts |
| Placebo | PLACEBO_COMPARATOR | Part A: Single ascending dose cohorts; Part B: Multiple ascending dose cohorts |
| 200 mg QD | EXPERIMENTAL | CG001419 |
| 200 mg BID | EXPERIMENTAL | CG001419 |
| 400 mg QD | EXPERIMENTAL | CG001419 |
| 800 mg QD | EXPERIMENTAL | CG001419 |
| 600 mg QD | EXPERIMENTAL | CG001419 |
| 1200 mg QD | EXPERIMENTAL | CG001419 |
| 1600 mg QD | EXPERIMENTAL | CG001419 |
| Name | Type | Description |
|---|---|---|
| CG001419 | DRUG | Oral doses |
| Placebo | DRUG | Oral doses |
| CG001419 tablets | DRUG | For QD administration, a single dose was given each morning. For BID administration, two doses were given 12 hours apart, one in the morning and one in the evening. Treatment Schedule:Repeated dosing was administered in 28-day treatment cycles. |
Inclusion Criteria: * Cis-male and cis-female subjects must be 18-65 years, inclusive, at the time of signing the informed consent form (ICF). * Subjects who are in good general health according to the judgment of the investigator per local guidance, eg, with no clinically relevant abnormalities ba...
CG001419 is an investigational small molecule being studied for the treatment of solid tumors harboring NTRK gene fusions. It is also being evaluated in a healthy volunteer study for pain management. The drug is administered orally as tablets and is currently in Phase 1 clinical development.
CG001419 targets TRK, a protein involved in cell growth and survival. By inhibiting TRK, the drug aims to address cancers driven by NTRK gene fusions. This targeted approach is being studied in patients with locally advanced or metastatic solid tumors that harbor NTRK gene abnormalities.
CG001419 is being developed by Pulmatrix, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this oral small molecule in patients with NTRK fusion-positive solid tumors and in healthy volunteers for pain management.
CG001419 is in Phase 1 clinical development. It is being studied in two trials: a completed Phase 1 study in healthy subjects and a recruiting Phase 1/2 study in adults with solid tumors harboring NTRK gene abnormalities. The drug is investigational and not yet approved.
CG001419 is being evaluated in two clinical trials. NCT06636500 is a completed Phase 1 study in healthy subjects in Australia, enrolling 72 participants. NCT07394374 is a recruiting Phase 1/2 study in China for adults with solid tumors harboring NTRK gene fusions, with a target enrollment of 42 participants.
Yes, CG001419 tablets is the oral formulation of CG001419. The drug is administered as tablets and is being studied in clinical trials for the treatment of solid tumors with NTRK gene fusions. The tablet form is the investigational product being evaluated in patients.