Last reviewed · How we verify
NCT07073534
Phase I/II Clinical Study on the Tolerability, Safety and Efficacy of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Phase 1/Phase 2 trial testing SHR-1501, Adebrelimab in Patients With Advanced or Metastatic Malignant Tumors in 203 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 203 |
| Start date | 24 July 2025 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-1501, Adebrelimab — full drug profile →
Conditions studied
- Patients With Advanced or Metastatic Malignant Tumors — all drugs for Patients With Advanced or Metastatic Malignant Tumors →
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Patients With Advanced or Metastatic Malignant Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose-limiting toxicity
Time frame: 21 Days or 28 days
evaluate the safety in the doses escalation -
Maximum tolerated dose or Maximum-administered dose
Time frame: Approximately 1 years
evaluate the safety in the doses escalation -
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2years.
evaluate the safety and curative effect in the doses escalation -
Objective response rate(ORR)
Time frame: Approximately 2 years
Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab -
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 21 Days,Approximately 2 years
Preliminary safety of the effectiveness of the combination of SHR-1501 and Adebrelimab
Sponsor's own description
This study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07073534
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shanghai Hengrui Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06877247 — A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism · Phase 1 · completed
- NCT06649292 — SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or M · Phase 3 · recruiting
- NCT06654440 — A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy · Phase 2 · recruiting
- NCT06639347 — A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma · Phase 1, PHASE2 · recruiting
- NCT06605222 — A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT07073534 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Hengrui Pharmaceutical Co., Ltd.
- Last refreshed: 20 January 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/NCT07073534.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing