A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors

NCT ID: NCT06605222

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2026-11-30

Brief Summary

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group: SHR-7787 injection

Group Type: EXPERIMENTAL

SHR-7787 injection

Intervention Type: DRUG

Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.

Interventions

SHR-7787 injection

Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;

2. Patients with unresectable recurrent or metastatic solid tumors;

3. There is at least one lesion could be measured;

4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;

5. Adequate organ functions as defined;

6. Life expectancy ≥3 months.

Exclusion Criteria

1. Patients with known active central nervous system (CNS) metastases;

2. Subjects who had other malignancy in five years before the first dose;

3. Patients with tumor-related pain that cannot be controlled as determined;

4. Patients with serious cardiovascular and cerebrovascular diseases;

5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;

6. Patients with Severe infections;

7. History of immunodeficiency;

8. History of autoimmune diseases;

9. Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy

10. Active infection;

11. Pregnant or nursing women;

12. Known history of serious allergic reactions to the investigational product or its main ingredients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ke Ma

Role: CONTACT

ke.ma@hengrui.com

+0518-81220121

Facility Contacts

Shengxiang Ren

Role: primary

Other Identifiers

SHR-7787-101

Identifier Type: -

Identifier Source: org_study_id