A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors

A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors

This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Tumors
• Intervention / Treatment: Drug: SHR-7787 Injection; Drug: SHR-1316 Injection; Drug: SHR-4849 Injection; Drug: Etoposide injection; Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: BP102 Injection

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xianhua Qiu; Phone Number: +86-0518-82342973; Email: xianhua.qiu@hengrui.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
      • Principal Investigator: Qian Chu
      • Contact: Qian Chu; Phone Number: +86-027-83663147; Email: qchu@hust.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Principal Investigator: Shengxiang Ren
      • Contact: Shengxiang Ren; Phone Number: 3051 +86-021-65115006; Email: arry_ren@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with histologically or cytologically confirmed unresectable solid tumors;
3. At least one measurable lesion was identified per RECIST 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined per protocol;
6. Minimum life expectancy of 3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases;
2. History of other malignancy within the past 5 years, with exceptions defined in the protocol;
3. Patients with uncontrolled cancer pain;
4. Patients with serious cardiovascular and/or cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections within 4 weeks prior to the first dose;
7. Active pulmonary tuberculosis infection;
8. History of immunodeficiency;
9. History of autoimmune diseases;
10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
11. Pregnant or nursing women, or planned to become pregnant during the study period;
12. Known allergic to any component of investigational drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-7787 combined with SHR-1316; SHR-7787 injection combined with SHR-1316 injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-1316 Injection; SHR-1316 Injection.
Experimental: SHR-7787 combined with SHR-4849; SHR-7787 injection combined with SHR-4849 injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-4849 Injection; SHR-4849 Injection.
Experimental: SHR-7787 combined with etoposide and carboplatin/cisplatin; SHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: Etoposide injection; Etoposide Injection.; Drug: Carboplatin injection; Carboplatin Injection.; Drug: Cisplatin injection; Cisplatin Injection.
Experimental: SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin; SHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-1316 Injection; SHR-1316 Injection.; Drug: Etoposide injection; Etoposide Injection.; Drug: Carboplatin injection; Carboplatin Injection.; Drug: Cisplatin injection; Cisplatin Injection.
Experimental: SHR-7787 combined with SHR-4849 and SHR-1316; SHR-7787 injection combined with SHR-4849 and SHR-1316 injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-1316 Injection; SHR-1316 Injection.; Drug: SHR-4849 Injection; SHR-4849 Injection.
Experimental: SHR-7787 combined with SHR-1316 and BP102; SHR-7787 injection combined with SHR-1316 and BP102 injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-1316 Injection; SHR-1316 Injection.; Drug: BP102 Injection; BP102 Injection.
Experimental: SHR-7787 combined with SHR-4849 and BP102; SHR-7787 injection combined with SHR-4849 and BP102 injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-4849 Injection; SHR-4849 Injection.; Drug: BP102 Injection; BP102 Injection.
Experimental: SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin; SHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.	Drug: SHR-7787 Injection; SHR-7787 Injection.; Drug: SHR-1316 Injection; SHR-1316 Injection.; Drug: SHR-4849 Injection; SHR-4849 Injection.; Drug: Carboplatin injection; Carboplatin Injection.; Drug: Cisplatin injection; Cisplatin Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)	Expected to be two years after the start of the study.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)	About 1 year after study initiation.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)	About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)	About 1 year after study initiation.
Objective response rate (ORR) (stage II)	Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)	Expected to be two years after the start of the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	About 1 year.
Duration of Response (DoR)	About 1 year.
Disease Control Rate (DCR)	About 1 year.
Progress Free Survival (PFS)	About 1 year.
Overall Survival (OS)	About 1 year.

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Etoposide; Carboplatin; Cisplatin
• Other Study ID Numbers: SHR-7787-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No