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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-7787 injection

• Registration Number: NCT06605222
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-14
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-20
• Status Verified: 2024-10
• Study Start: 2024-10-04
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-07-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group: SHR-7787 injection	SHR-7787 injection	-

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose	first dose of study medication up to 21 days	The Recommended phase II dose of SHR-7787 injection monotherapy
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Maximum tolerated dose	first dose of study medication up to 21 days	The Maximum tolerated dose of SHR-7787 injection monotherapy
Incidence of Dose Limited Toxicity (DLT)	from first dose to 4 weeks	Incidence of Dose Limited Toxicity (DLT) described in the protocol

Secondary Outcome Measures

Name	Time	Method
Tmax	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose	PK parameters of single dose of SHR-7787 injection monotherapy
Cmax	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose	PK parameters of single dose of SHR-7787 injection monotherapy
AUC0-t	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose	PK parameters of single dose of SHR-7787 injection monotherapy
t1/2	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose	PK parameters of single dose of SHR-7787 injection monotherapy
ADA	0.5 hour before first dose through study completion, an average of 1 year	Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy
ORR	from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months	Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China