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NCT04946864
A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer
Phase 1, PHASE2 trial testing APG-2575 in Breast Cancer in 65 participants. Suspended.
12 August 2024
Quick facts
| Lead sponsor | Ascentage Pharma Group Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 13 August 2021 |
| Primary completion | 12 August 2024 |
| Estimated completion | 1 October 2024 |
| Sites | 7 locations across China, United States |
Drugs / interventions tested
- APG-2575 — full drug profile →
- Palbociclib (Palbociclib) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
Sponsor
Ascentage Pharma Group Inc. — full company profile →
Who can join
Adults 18 to 99, any sex, with Breast Cancer or Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2- metastatic breast cancer (mBC) who have progressed or relapsed after first line therapy
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
The Present and Future of Clinical Management in Metastatic Breast Cancer.
Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891 -
Unveiling the Potential of Cyclin-Dependent Kinases 4 and 6 Inhibitors Beyond Progression in Hormone Receptor Positive/Human Epidermal Growth Factor Negative Advanced Breast Cancer - A Clinical Review.
Benvenuti C, Grinda T, Rassy E, Dixon-Douglas J, et al · · 2024 · cited 4× · PMID 39614985 · DOI 10.1007/s11864-024-01259-4 -
Emerging opportunities to treat drug-resistant breast cancer: Discovery of novel small-molecule inhibitors against different targets.
Chen R, Zhou Z, Meng X, Lei Y, et al · · 2025 · cited 1× · PMID 40949156 · DOI 10.3389/fphar.2025.1578342
Verify or expand the search:
- PubMed search for NCT04946864
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of APG-2575
Trials testing the same drug.
- NCT05701306 — APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors · Phase 1 · recruiting
- NCT04496349 — A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL · Phase 2 · recruiting
- NCT03913949 — A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies · Phase 1 · active not recruiting
- NCT03537482 — APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies · EARLY_PHASE1 · recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Ascentage Pharma Group Inc. trials
Trials by the same sponsor.
- NCT07282093 — Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment · Phase 1 · recruiting
- NCT06640361 — A Study of Olverembatinib in SDH-deficient GIST. · Phase 3 · recruiting
- NCT06389292 — A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia · Phase 3 · recruiting
- NCT06104566 — Global Trial in APG2575 for Patients With CLL/SLL · Phase 3 · recruiting
- NCT06051409 — A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL. · Phase 3 · recruiting
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 NCT04946864 (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 Ascentage Pharma Group Inc.
- Last refreshed: 19 August 2024
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/NCT04946864.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing