Clinical trial · Interventional
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
NCT06710379CI-TRIAL-00088324recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADRX-0405 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose Escalation
- description
- 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.
- interventionNames
- Drug: ADRX-0405
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Expansion
- description
- ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC.
- interventionNames
- Drug: ADRX-0405
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.