NCT06036121

A Study of ADRX-0706 in Select Advanced Solid Tumors

A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Adcentrx Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.

Detailed description

This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

Conditions

• Solid Tumors
• Triple Negative Breast Cancer (TNBC)
• Urothelial Cancer
• Cervical Cancer

Interventions

Type	Name	Description
DRUG	ADRX-0706	Antibody drug conjugate targeting Nectin-4

Timeline

• Start date: 2023-09-26
• Primary completion: 2025-09-01
• Completion: 2026-12-01
• First posted: 2023-09-13
• Last updated: 2025-08-17

Locations

21 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study