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NCT06331559
Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
Phase 1 trial testing SIM0501 Tablets in Advanced Solid Tumors in 13 participants. Terminated before completion.
17 September 2025
Quick facts
| Lead sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 19 March 2024 |
| Primary completion | 17 September 2025 |
| Estimated completion | 17 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- SIM0501 Tablets — full drug profile →
- SIM0501 Tablets — full drug profile →
- SIM0501 in combination with olaparib — full drug profile →
- SIM0501 in combination with olaparib — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
DNA repair and the contribution to chemotherapy resistance.
Nesic K, Parker P, Swisher EM, Krais JJ. · · 2025 · cited 16× · PMID 40420317 · DOI 10.1186/s13073-025-01488-8 -
Ubiquitin-Specific Protease Inhibitors for Cancer Therapy: Recent Advances and Future Prospects.
Bakkar M, Khalil S, Bhayekar K, Kushwaha ND, et al · · 2025 · cited 10× · PMID 40001543 · DOI 10.3390/biom15020240 -
Role of Ubiquitin-regulated EMT in Cancer Metastasis and Chemoresistance.
Xiao S, Tian L, Gan X, Xu X, et al · · 2025 · cited 4× · PMID 41208892 · DOI 10.7150/ijbs.115401 -
Synthetic lethality in cancer therapy: Mechanisms, models and clinical translation for overcoming therapeutic resistance.
Li J, Zhang L, Shang Y, Liu J, et al · · 2026 · cited 1× · PMID 41537447 · DOI 10.1002/ctm2.70586 -
Pharmacologic interrogation of USP28 cellular function in p53 signaling.
Bratt AS, Kilgas S, Tarazona Guzman MI, Magin RS, et al · · 2025 · PMID 40902594 · DOI 10.1016/j.chembiol.2025.08.002
Verify or expand the search:
- PubMed search for NCT06331559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
- NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
- NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Jiangsu Simcere Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07345364 — A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics · Phase 1 · not yet recruiting
- NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
- NCT07175233 — A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 2 · not yet recruiting
- NCT06686745 — Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT06680921 — A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Brea · 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 NCT06331559 (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 Jiangsu Simcere Pharmaceutical Co., Ltd.
- Last refreshed: 9 February 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/NCT06331559.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing