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NCT Number: NCT06605222

A Trial of SHR-7787 Injection 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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Shengxiang Ren

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-7787 Injection

Drug

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

Primary outcomes

  1. Maximum tolerated dose

    Time frame: first dose of study medication up to 21 days

    The Maximum tolerated dose of SHR-7787 injection monotherapy

  2. Recommended phase II dose

    Time frame: first dose of study medication up to 21 days

    The Recommended phase II dose of SHR-7787 injection monotherapy

  3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

    Time frame: 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

  4. Incidence of Dose Limited Toxicity (DLT)

    Time frame: from first dose to 4 weeks

    Incidence of Dose Limited Toxicity (DLT) described in the protocol

Secondary outcomes

  1. Tmax

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

    PK parameters of single dose of SHR-7787 injection monotherapy

  2. Cmax

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

    PK parameters of single dose of SHR-7787 injection monotherapy

  3. AUC0-t

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

    PK parameters of single dose of SHR-7787 injection monotherapy

  4. t1/2

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

    PK parameters of single dose of SHR-7787 injection monotherapy

  5. ADA

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

    Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy

  6. ORR

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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