NCT06710379

A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (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-0405 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-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)\], 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-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	ADRX-0405	Antibody Drug Conjugate targeting STEAP1

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-11-29
• Last updated: 2025-04-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study