NCT06361927

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 8, 2024

Last Update Submit

May 14, 2024

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective response rate

    12 months

Secondary Outcomes (1)

  • Safety and tolerability

    12 months

Study Arms (6)

cohort A：dose level 1 of SSGJ-707

EXPERIMENTAL
Drug: SSGJ-707

cohort A：dose level 2 of SSGJ-707

EXPERIMENTAL
Drug: SSGJ-707

cohort A：dose level 3 of SSGJ-707

EXPERIMENTAL
Drug: SSGJ-707

cohort B：dose level 1 of SSGJ-707

EXPERIMENTAL
Drug: SSGJ-707

cohort B：dose level 2 of SSGJ-707

EXPERIMENTAL

cohort B

Drug: SSGJ-707

cohort B：dose level 3 of SSGJ-707

EXPERIMENTAL
Drug: SSGJ-707

Interventions

SSGJ-707DRUG

bispecific antibody

cohort A：dose level 1 of SSGJ-707cohort A：dose level 2 of SSGJ-707cohort A：dose level 3 of SSGJ-707cohort B：dose level 1 of SSGJ-707cohort B：dose level 2 of SSGJ-707cohort B：dose level 3 of SSGJ-707

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Study Officials

  • Lin Wu, MD, Ph.D

    The Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Wu, MD, Ph.D

CONTACT

0731-89762302wulin-calf@vip.163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

May 15, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)