drugset / Trial / NCT06761651

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651 ↗

Phase 1 Recruiting 50 enrolled Tavotek Biotherapeutics
Non-randomizedSingle-groupOpen-labelTreatment

Summary

TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR \> PR \> SD) from Part 1 that progressed on prior approved standard of care therapy.

Timeline

Start
2023-12-20
Primary completion
2026-01-01
Completion
2026-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject TAVO412 Unknown 150 mg Intravenous
Subject TAVO412 Unknown 375 mg Intravenous
Subject TAVO412 Unknown 750 mg Intravenous
Subject TAVO412 Unknown 1125 mg Intravenous
Subject TAVO412 Unknown 1500 mg Intravenous
Subject TAVO412 Unknown 1750 mg Intravenous

Indications