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
Maximum tolerated dose	first dose of study medication up to 21 days	The Maximum tolerated dose of SHR-7787 injection monotherapy
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
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