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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

Austin

NEXT Austin, Austin, Texas, United States, 78758

West Valley City

START Mountain Region, West Valley City, Utah, United States, 84119

Fairfax

NEXT 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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Adcentrx Therapeutics,

Study Record Dates

2026-12