NCT05060276

Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors

A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.

Detailed description

This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers. The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.

Conditions

• Relapsed Solid Neoplasm
• Refractory Cancer
• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	STI-3258	Intravenous infusion of STI-3258 will be given (one infusion every three weeks).

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-05-01
• Completion: 2024-12-01
• First posted: 2021-09-29
• Last updated: 2023-01-26

Regulatory

• FDA-regulated drug study