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NCT03725436
ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors
Phase 1 trial testing MDM2/MDMX Inhibitor ALRN-6924 in Advanced Malignant Solid Neoplasm in 28 participants. Completed in 11 March 2026.
11 March 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 24 January 2019 |
| Primary completion | 11 March 2026 |
| Estimated completion | 11 March 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MDM2/MDMX Inhibitor ALRN-6924 — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
- Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
- Anatomic Stage IIIA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIA Breast Cancer AJCC v8 →
- Anatomic Stage IIIB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIB Breast Cancer AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Advanced Malignant Solid Neoplasm or Anatomic Stage III Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ALRN-6924 and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y -
Targeting p53 pathways: mechanisms, structures, and advances in therapy.
Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1 -
Drugging p53 in cancer: one protein, many targets.
Hassin O, Oren M. · · 2023 · cited 496× · PMID 36216888 · DOI 10.1038/s41573-022-00571-8 -
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
The Role of p53 Signaling in Colorectal Cancer.
Liebl MC, Hofmann TG. · · 2021 · cited 231× · PMID 33924934 · DOI 10.3390/cancers13092125 -
Role of p53 in breast cancer progression: An insight into p53 targeted therapy.
Marvalim C, Datta A, Lee SC. · · 2023 · cited 142× · PMID 36923534 · DOI 10.7150/thno.81847 -
The role of cell-penetrating peptides in potential anti-cancer therapy.
Zhou M, Zou X, Cheng K, Zhong S, et al · · 2022 · cited 89× · PMID 35593206 · DOI 10.1002/ctm2.822 -
MDM2 Inhibitors for Cancer Therapy: The Past, Present, and Future.
Wang W, Albadari N, Du Y, Fowler JF, et al · · 2024 · cited 85× · PMID 38697854 · DOI 10.1124/pharmrev.123.001026
Verify or expand the search:
- PubMed search for NCT03725436
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03725436 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03725436.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing