Trial Profile
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Status:
Recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 13 Mar 2024
Price :
$35
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At a glance
- Drugs Repotrectinib (Primary) ; Midazolam
- Indications Non-small cell lung cancer; Salivary gland cancer; Soft tissue sarcoma; Solid tumours; Thyroid cancer
- Focus Adverse reactions; First in man; Registrational; Therapeutic Use
- Acronyms TRIDENT-1
- Sponsors Turning Point Therapeutics
- 27 Feb 2024 According to ZAI Lab media release, the Zai Lab has submitted New Drug Application (NDA) of repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC is under priority review in China.
- 14 Feb 2024 According to Bristol Myers Squibb media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors.The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024.
- 11 Jan 2024 Results assessing the efficacy and safety of repotrectinib , published in the New England Journal of Medicine