Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors

NCT07073534 | Recruiting Phase 1

• 1 other identifier: SHR-1501-202
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Advanced or Metastatic Malignant Tumors

Outcome Measures

Primary Outcomes (5)

• Dose-limiting toxicity

  evaluate the safety in the doses escalation

  21 Days or 28 days

• Maximum tolerated dose or Maximum-administered dose

  evaluate the safety in the doses escalation

  Approximately 1 years

• Recommended Phase 2 dose (RP2D)

  evaluate the safety and curative effect in the doses escalation

  Approximately 2years.

• Objective response rate(ORR)

  Preliminary evaluation of the effectiveness of the combination of SHR-1501 and Adebrelimab

  Approximately 2 years

• The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

  Preliminary safety of the effectiveness of the combination of SHR-1501 and Adebrelimab

  21 Days，Approximately 2 years

Secondary Outcomes (10)

• Maximum concentration (Cmax) of SHR-1501

  Approximately 2 years

• Time to maximum concentration (Tmax) of SHR-1501

  Approximately 2 years

• Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501

  Approximately 2 years

• Steady-state valley concentration (Cmin)of SHR-1501

  Approximately 2 years

• Accumulation ratio（Rac） of SHR-1501

  Approximately 2 years

Study Arms (1)

the combination of SHR-1501 and Adebrelimab

EXPERIMENTAL

Drug: SHR-1501, Adebrelimab

Interventions

SHR-1501, Adebrelimab DRUG

the combination of SHR-1501 and Adebrelimab

the combination of SHR-1501 and Adebrelimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person.
• Age: 18 to 75 years old (including both ends), gender not limited.
• Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment.
• According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion;
• The ECOG physical condition score is 0 or 1.
• The expected survival time is more than 3 months;

You may not qualify if:

• Symptomatic or active central nervous system (CNS) tumor metastasis;
• Other malignant tumors within five years before the first use of study drugs;
• Uncontrolled tumor-related pain judged by the investigator;
• Severe cardiovascular and cerebrovascular diseases;
• Significant clinical bleeding symptoms within 3 months before the first study drug, and obvious fresh hemoptysis within 1 month before the first study drug;
• Uncontrollable pleural effusion and/or ascites judged by the study or pleural effusion and/or ascites requiring intervention within 7 days before the first treatment
• History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-related pneumonia requiring steroid therapy;,or active pneumonia at screening; or other moderate to severe pulmonary diseases that significantly affect pulmonary function;
• Severe infection within 4 weeks before the start of study treatment
• History of immunodeficiency
• Used corticosteroids (\>10 mg/day prednisone or equivalent) or other systemic immunosuppressants within 14 days before the first study drug.
• Patients with active pulmonary tuberculosis infection within 1 year before enrollment as determined by medical history or imaging examination, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment
• Patients whose adverse events caused by previous treatment have not recovered to ≤CTCAE grade 1
• Patients whose previous treatment washout does not meet the following requirements: Patients who have received chemotherapy, biological therapy, targeted therapy, immunotherapy, or other unlisted clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug
• Patients who have experienced CTCAE grade 4 or grade 3 immune-related adverse events lasting for 4 weeks or longer after previous use of immune checkpoint inhibitors, or immune-related adverse events that led to treatment discontinuation, are not eligible for enrollment in this study.
• Patients who have received \>30 Gy chest radiotherapy within 24 weeks before the first use of the study drug, patients who have received \>30 Gy non-chest radiotherapy within 4 weeks before the first use of the drug (subjects who have completed brain metastasis radiotherapy 14 days before the first use of the drug can be enrolled), and patients who have received ≤30 Gy within 14 days before the first use of the drug Gy of palliative radiation;

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Fei Qiu

CONTACT

+0518-81220121; fei.qiu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-07

Locations

CN (1)