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

Phase 1

Recruiting

• Conditions: Solid Tumors
• Interventions: Drug: ADRX-0405

• Registration Number: NCT06710379
• Lead Sponsor: Adcentrx Therapeutics

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Study Start: 2024-12-30
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1a Dose Escalation	ADRX-0405	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.
Phase 1b Dose Expansion	ADRX-0405	ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Until study completion (estimated 2 years)

Secondary Outcome Measures

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

Trial Locations

Locations (8)

City of Hope; 🇺🇸 Duarte, California, United States

UCLA; 🇺🇸 Santa Monica, California, United States

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

START Midwest; 🇺🇸 Grand Rapids, Michigan, United States

NEXT Austin; 🇺🇸 Austin, Texas, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States