NCT05001516

Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors

A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of TPX4589 in Patients With Claudin(CLDN)18.2-Positive Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Turning Point Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors

Detailed description

A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LM-302	All subjects will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-302 intravenous infusion on day 1 until meet the criteria of treatment discontinuation or withdraw, whichever occurs earlier.

Timeline

• Start date: 2021-12-29
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2021-08-12
• Last updated: 2024-04-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study