Clinical trial · Interventional
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
- 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)
This first-in-human study is designed to establish the safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma whose tumor has progressed on standard therapy. Information will also be collected to determine how long ATR-101 stays in the blood, and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen and testosterone) are seen.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ACC | — | UNRESOLVED | — |
| Adrenal Cancer | Malignant Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATR-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATR-101
- description
- ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
- interventionNames
- Drug: ATR-101
Primary outcomes (1)
- measure
- Frequency of dose-limiting toxicity and determination of maximum tolerated dose
- timeFrame
- Occurrence of DLT at 28 days
- description
- Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.
Secondary outcomes (3)
- measure
- Area under the plasma concentration versus time curve (AUC) of ATR-101
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 18 years; * Clinical confirmation of adrenocortical carcinoma that is locally advanced or metastatic and not amendable to surgical resection; * Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based chemotherapy regimen; * Able to understand and comply with the protocol requirements; * Willing and able to provide informed consent. Exclusion Criteria: * Mitotane level \> 5 * Use of contraindicated concomitant medications * Unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.
References
Publications (2)
- DERIVEDSmith DC, Kroiss M, Kebebew E, Habra MA, Chugh R, Schneider BJ, Fassnacht M, Jafarinasabian P, Ijzerman MM, Lin VH, Mohideen P, Naing A. A phase 1 study of nevanimibe HCl, a novel adrenal-specific sterol O-acyltransferase 1 (SOAT1) inhibitor, in adrenocortical carcinoma. Invest New Drugs. 2020 Oct;38(5):1421-1429. doi: 10.1007/s10637-020-00899-1. Epub 2020 Jan 27. PMID 31984451
- DERIVEDLalli E, Sasano H. 5th International ACC Symposium: An Outlook to Current and Future Research on the Biology of Adrenocortical Carcinoma: Diagnostic and Therapeutic Applications. Horm Cancer. 2016 Feb;7(1):44-8. doi: 10.1007/s12672-015-0240-3. Epub 2015 Dec 14. PMID 26666256