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

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

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

Exclusion criteria

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. 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).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. 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)

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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