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NCT06710379PHASE1Recruiting

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

Adcentrx Therapeutics

Start Date

12/30/2024

Completion Date

12/1/2026

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).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC). * Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone \< 50 ng/dL \[\< 2.0 nM\]) and that is intolerant/resistant to standard of care (SOC) therapies. * Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b * Adequate hematologic, liver, and renal function Exclusion Criteria: * Active and uncontrolled central nervous system metastases * Significant cardiovascular disease * History of another malignancy other than the one for which the subject is being treated on this study within 3 years * Receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer * History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Interventions

DRUG

ADRX-0405

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Conditions

Solid Tumors

Locations

City of Hope

Duarte, California 91010

United States

UCLA

Santa Monica, California 90404

United States

START Midwest

Grand Rapids, Michigan 49546

United States

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota 55455

United States

NEXT Austin

Austin, Texas 78758

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

START Mountain Region

West Valley City, Utah 84119

United States

NEXT Virginia

Fairfax, Virginia 22031

United States