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NCT Number: NCT06710379

A 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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADRX-0405

Drug

Antibody Drug Conjugate targeting STEAP1

Primary outcomes

  1. Incidence of adverse events

    Time frame: Until study completion (estimated 2 years)

Secondary outcomes

  1. 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

  2. Measurement of trough concentration (Ctrough) of ADRX-0405

    Time frame: Until study completion (estimated 2 years)

    Measured from PK blood samples

  3. 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

  4. 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

  5. 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

  6. 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

  7. Incidence of anti-drug antibody (ADA) to ADRX-0405

    Time frame: Until study completion (estimated 2 years)

    Measured from ADA blood samples

  8. 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)

  9. 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)

  10. 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

  11. Measurement of disease control rate (DCR)

    Time frame: Until study completion (estimated 2 years)

    Percentage of subjects achieving CR, PR or stable disease (SD)

  12. 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

  13. 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

  14. 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

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Adcentrx Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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