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

NCT06605222 | Recruiting Phase 1

• 1 other identifier: SHR-7787-101
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Tmax

  predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose

• Cmax

  predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose

• AUC0-t

  predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose

• t1/2

  predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose

• ADA

  0.5 hour before first dose through study completion, an average of 1 year

Study Arms (1)

Single Group: SHR-7787 injection

EXPERIMENTAL

Drug: SHR-7787 injection

Interventions

SHR-7787 injection DRUG

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

Single Group: SHR-7787 injection

Eligibility Criteria

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

You may qualify if:

• Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
• Patients with unresectable recurrent or metastatic solid tumors;
• There is at least one lesion could be measured;
• An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Adequate organ functions as defined;
• Life expectancy ≥3 months.

You may not qualify if:

• Patients with known active central nervous system (CNS) metastases;
• Subjects who had other malignancy in five years before the first dose;
• Patients with tumor-related pain that cannot be controlled as determined;
• Patients with serious cardiovascular and cerebrovascular diseases;
• Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
• Patients with Severe infections;
• History of immunodeficiency;
• History of autoimmune diseases;
• Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
• Active infection;
• Pregnant or nursing women;
• Known history of serious allergic reactions to the investigational product or its main ingredients.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Ke Ma

CONTACT

+0518-81220121; ke.ma@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

Model Details: SHR-7787 injection monotherapy

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 20, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)