NCT06710379 A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
| NCT ID | NCT06710379 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adcentrx Therapeutics |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 68 participants in total. It began in 2024-12-30 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06710379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06710379 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06710379 currently recruiting?
Yes, NCT06710379 is actively recruiting participants. Contact the research team at clinicaltrials@adcentrx.com for enrollment information.
Where is the NCT06710379 trial being conducted?
This trial is being conducted at Duarte, United States, Santa Monica, United States, Grand Rapids, United States, Minneapolis, United States and 4 additional locations.
Who is sponsoring the NCT06710379 clinical trial?
NCT06710379 is sponsored by Adcentrx Therapeutics. The trial plans to enroll 68 participants.