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

April 7, 2025 updated by: Adcentrx Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
      • Santa Monica, California, United States, 90404
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Masonic Cancer Center
        • Contact:
          • Patricia Beckman, RN
          • Phone Number: 612-624-2620
          • Email: ccinfo@umn.edu
    • Texas
      • Austin, Texas, United States, 78758
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
    • Utah
      • West Valley City, Utah, United States, 84119
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: ADRX-0405
Antibody Drug Conjugate targeting STEAP1
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.
Drug: ADRX-0405
Antibody Drug Conjugate targeting STEAP1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Until study completion (estimated 2 years)
Until study completion (estimated 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from pharmacokinetic (PK) blood samples
Until study completion (estimated 2 years)
Measurement of trough concentration (Ctrough) of ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from PK blood samples
Until study completion (estimated 2 years)
Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from PK blood samples
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
Time Frame: Until study completion (estimated 2 years)
Measured from PK blood samples
Until study completion (estimated 2 years)
Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from PK blood samples
Until study completion (estimated 2 years)
Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from PK blood samples
Until study completion (estimated 2 years)
Incidence of anti-drug antibody (ADA) to ADRX-0405
Time Frame: Until study completion (estimated 2 years)
Measured from ADA blood samples
Until study completion (estimated 2 years)
Measurement of objective response rate (ORR) per RECIST 1.1
Time Frame: Until study completion (estimated 2 years)
Percentage of subjects achieving complete response (CR) or partial response (PR)
Until study completion (estimated 2 years)
ORR per Prostate Cancer Working Group 3 (PCWG3)
Time Frame: Until study completion (estimated 2 years)
Percentage of subjects achieving complete response (CR) or partial response (PR)
Until study completion (estimated 2 years)
Measurement of duration of response (DOR)
Time Frame: Until study completion (estimated 2 years)
Time from first response until first evidence of disease progression (PD) or death from any cause
Until study completion (estimated 2 years)
Measurement of disease control rate (DCR)
Time Frame: Until study completion (estimated 2 years)
Percentage of subjects achieving CR, PR or stable disease (SD)
Until study completion (estimated 2 years)
Measurement of progression free survival (PFS)
Time Frame: Until study completion (estimated 2 years)
Time from the start of study drug until first evidence of PD or death from any cause
Until study completion (estimated 2 years)
Measurement of radiographic progression free survival (rPFS)
Time Frame: Until study completion (estimated 2 years)
Time from the start of study drug until first radiographic documentation of PD, or death from any cause, whichever comes first
Until study completion (estimated 2 years)
Measurement of overall survival (OS)
Time Frame: Until study completion (estimated 2 years)
Time from the start of study drug until death from any cause
Until study completion (estimated 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adcentrx Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADRX-0405-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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