Recruiting
Phase 1

ADRX-0405

Sponsor:

Adcentrx Therapeutics

Code:

NCT06710379

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADRX-0405

Study Details

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

Study ID

NCT06710379

Start date

Dec 30, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a Dose Escalation

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.

experimental: Phase 1b Dose Expansion

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

Interventions

ADRX-0405

Antibody Drug Conjugate targeting STEAP1

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Until study completion (estimated 2 years) ]

Central Contacts and Locations

Central contacts

Adcentrx Therapeutics

858-428-9502clinicaltrials@adcentrx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Erin Morones

626-218-9708emorones@coh.org

UCLA

Recruiting

Santa Monica, California, United States, 90404

Contacts

Rosa Vazquez

310-633-8400ravazquez@mednet.ucla.edu

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Julie Burns

616-954-5559julie.burns@startresearch.com

University of Minnesota Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Patricia Beckman, RN

612-624-2620ccinfo@umn.edu

NEXT Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Suhrutha Bushan

(737) 610-5202sbushan@nextoncology.com

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jordi Rodon Ahnert, MD, PhD

713-792-5603jrodon@mdanderson.org

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Marie Asay

801-907-4770marie.asay@startresearch.com

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

(703) 783-4505bpatterson@nextoncology.com

More Information

Sponsor

Adcentrx Therapeutics

Last update posted

Apr 9, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Adcentrx Therapeutics on 2025-04-09.