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

A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-7787 injection

• Study Type: Interventional
• Enrollment (Estimated): 201
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ke Ma; Phone Number: +0518-81220121; Email: ke.ma@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Shengxiang Ren

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Group: SHR-7787 injection	Drug: SHR-7787 injection; Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose	The Maximum tolerated dose of SHR-7787 injection monotherapy	first dose of study medication up to 21 days
Recommended phase II dose	The Recommended phase II dose of SHR-7787 injection monotherapy	first dose of study medication up to 21 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	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 of Dose Limited Toxicity (DLT)	Incidence of Dose Limited Toxicity (DLT) described in the protocol	from first dose to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	PK parameters of single dose of SHR-7787 injection monotherapy	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
Cmax	PK parameters of single dose of SHR-7787 injection monotherapy	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
AUC0-t	PK parameters of single dose of SHR-7787 injection monotherapy	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
t1/2	PK parameters of single dose of SHR-7787 injection monotherapy	predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose
ADA	Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy	0.5 hour before first dose through study completion, an average of 1 year
ORR	Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors	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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-7787-101

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