Testing ADRX-0405 in patients with advanced solid tumors
A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
PHASE1 · Adcentrx Therapeutics · NCT06710379
This study is testing a new treatment called ADRX-0405 to see if it is safe and effective for people with advanced solid tumors like prostate, gastric, and lung cancer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adcentrx Therapeutics (industry) |
| Locations | 8 sites (Duarte, California and 7 other locations) |
| Trial ID | NCT06710379 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and pharmacokinetics of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. The study is divided into two parts: Phase 1a focuses on dose escalation to determine the recommended dose, while Phase 1b assesses the safety and preliminary efficacy of the optimal dose in patients with previously treated metastatic castration resistant prostate cancer. Participants will undergo monitoring for adverse effects and treatment response throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed advanced solid tumors, particularly those with metastatic castration resistant prostate cancer, gastric cancer, or non-small cell lung cancer.
Not a fit: Patients with active and uncontrolled central nervous system metastases or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but the specific use of ADRX-0405 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Duarte, California and 7 other locations
- City of Hope — Duarte, California, United States (RECRUITING)
- UCLA — Santa Monica, California, United States (RECRUITING)
- START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
- University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States (RECRUITING)
- NEXT Austin — Austin, Texas, United States (RECRUITING)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- START Mountain Region — West Valley City, Utah, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Adcentrx Therapeutics
- Email: clinicaltrials@adcentrx.com
- Phone: 858-428-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumors