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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2026
  • participants needed
    68
  • sponsor
    Adcentrx Therapeutics
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Updated on 2 December 2024
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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.

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).

Details
Condition Solid Tumors
Age 18years or above
Clinical Study IdentifierNCT06710379
SponsorAdcentrx Therapeutics
Last Modified on2 December 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

</p><ul><li>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).</li><li>Phase 1b Dose Expansion: Subjects with
histologically confirmed prostate adenocarcinoma that is confirmed to be
castration resistant (i.e., serum testosterone &lt; 50 ng& x2F ;dL [&lt; 2.0
nM]) and that is intolerant&x2F;resistant to standard of care (SOC)
therapies.</li><li>Measurable disease according to RECIST version 1.1 or
evaluable disease per PCWG3 for subjects with prostate cancer</li><li>Eastern
Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in
b</li><li>Adequate hematologic, liver, and renal

Exclusion Criteria

</p><ul><li>Active and uncontrolled
central nervous system metastases</li><li>Significant cardiovascular
disease</li><li>History of another malignancy other than the one for which the
subject is being treated on this study within 3 years</li><li>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</li><li>History of (non-infectious) ILD& x2F ;pneumonitis
that required steroids within 2 years of study enrollment, has current
ILD&x2F;pneumonitis, or where suspected ILD&#x2F;pneumonitis cannot be ruled
out by imaging at screening.</li><li>Receiving systemic antimicrobial
treatment for active infection; routine antimicrobial prophylaxis is
permitted</li></ul>
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