Clinical trial · Interventional
A Study of ADRX-0706 in Select Advanced Solid Tumors
A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors
NCT06036121CI-TRIAL-00093787active not recruitingPhase 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-0706 in patients with select advanced solid tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADRX-0706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose Escalation
- description
- Increasing doses of ADRX-0706 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-0706
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Expansion
- description
- ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer.
- interventionNames
- Drug: ADRX-0706
Primary outcomes (1)
- measure
- Incidence of adverse events
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 urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator. * Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the opinion of the investigator, unless subject refuses standard therapy. * Measurable disease according to RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * 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) * Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug * 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.