RecruitingPhase 2NCT06361927

A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients


Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

120 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • Males and/or females over age 18
  • Histologically and/or cytologically documented local advanced or metastatic NSCLC .
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival >=3 months.
  • Signed informed consent form.

Exclusion Criteria5

  • Known uncontrolled or symptomatic central nervous system metastatic disease.
  • Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
  • Inadequate organ or bone marrow function.
  • Pregnant or breast-feeding woman.
  • Known allergies, hypersensitivity, or intolerance to SSGJ-707. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Interventions

DRUGSSGJ-707

bispecific antibody


Locations(1)

The Hunan Cancer Hospital

Changsha, Hunan, China

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NCT06361927


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