A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors

NCT07123129 | Recruiting Phase 1

• 1 other identifier: SHR-7782-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.

Conditions

Advanced Malignancy

Outcome Measures

Primary Outcomes (3)

• Dose Limited Toxicity (DLT)

  Up to 21 days.

• Maximum Tolerated Dose (MTD)

  Up to 6 months.

• Recommended Phase II Dose (RP2D)

  Up to 21 days.

Secondary Outcomes (5)

• Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 24 months.

• Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 24 months.

• Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 24 months.

• Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 24 months.

• Overall Survival (OS)

  Up to approximately 24 months.

Study Arms (1)

SHR-7782 Group

EXPERIMENTAL

Drug: SHR-7782 Injection

Interventions

SHR-7782 Injection DRUG

SHR-7782 injection.

SHR-7782 Group

Eligibility Criteria

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

You may qualify if:

• Participate in the study voluntarily, sign the informed consent form.
• Subjects were able to provide primary or metastatic cancer samples.
• At least one measurable lesion (RECIST version 1.1).
• ECOG 0\~1.
• With adequate organ functions.
• Expected survival time ≥ 12 weeks.

You may not qualify if:

• With untreated brain metastasis or active central nervous system tumor metastases.
• Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
• Patients with other malignant tumors in the past or at the same time.
• Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
• Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
• With poorly controlled or severe cardiovascular disease.
• Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
• Subjects who had a serious infection within 1 month before the first medication.
• History of immunodeficiency.
• Known allergy to any component of the SHR-7782 product.
• According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100020, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Zhifei Lin

CONTACT

+86-0518-82342973; zhifei.lin.zl3@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: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (2)