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

S

Sunshine Guojian Pharmaceutical

Status and phase

Enrolling
Phase 2

Conditions

NSCLC

Treatments

Drug: SSGJ-707

Study type

Interventional

Funder types

Industry

Identifiers

NCT06361927
SSGJ-707-NSCLC-II-01

Details and patient eligibility

About

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

Full description

This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 6 patient groups

cohort A:dose level 1 of SSGJ-707
Experimental group
Treatment:
Drug: SSGJ-707
cohort A:dose level 2 of SSGJ-707
Experimental group
Treatment:
Drug: SSGJ-707
cohort A:dose level 3 of SSGJ-707
Experimental group
Treatment:
Drug: SSGJ-707
cohort B:dose level 1 of SSGJ-707
Experimental group
Treatment:
Drug: SSGJ-707
cohort B:dose level 2 of SSGJ-707
Experimental group
Description:
cohort B
Treatment:
Drug: SSGJ-707
cohort B:dose level 3 of SSGJ-707
Experimental group
Treatment:
Drug: SSGJ-707

Trial contacts and locations

1

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Central trial contact

Lin Wu, MD, Ph.D

Data sourced from clinicaltrials.gov

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