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

NCT06710379 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ADRX-0405-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Until study completion (estimated 2 years)

Secondary Outcomes (14)

• Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405

  Until study completion (estimated 2 years)

• Measurement of trough concentration (Ctrough) of ADRX-0405

  Until study completion (estimated 2 years)

• Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405

  Until study completion (estimated 2 years)

• Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate

  Until study completion (estimated 2 years)

• Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405

  Until study completion (estimated 2 years)

Study Arms (2)

Phase 1a Dose Escalation

EXPERIMENTAL

Increasing doses of ADRX-0405 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.

Drug: ADRX-0405

Phase 1b Dose Expansion

EXPERIMENTAL

ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC.

Drug: ADRX-0405

Interventions

ADRX-0405 DRUG

Antibody Drug Conjugate targeting STEAP1

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adcentrx Therapeutics: lead

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

RECRUITING

UCLA

Santa Monica, California, 90404, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

NEXT Austin

Austin, Texas, 78758, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Central Study Contacts

Adcentrx Therapeutics

CONTACT

858-428-9502; clinicaltrials@adcentrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)