Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Location status: Recruiting
NCT Number: NCT06390774
This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Jinan, Shandong, China
Location status: Recruiting
This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
anti-PD-1 and anti-HER2 bispecific antibody
Time frame: 14 days
Dose limiting toxicity
Time frame: up to 1 year
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: up to 1 year
maximum tolerated dose or the maximum administered dose if MTD is not reached
Time frame: up to 1 year
the recommended phase II dose
Time frame: up to 1 year
Objective response rate
Time frame: up to 1 year
Progression-free Survival
Time frame: up to 1 year
Maximum Plasma Concentration
Time frame: up to 1 year
Half-life
Contact information is provided by the study sponsor or research team.
Jinming Yu, MD,Ph.D
CONTACT
Yuping Sun, MD,Ph.D
CONTACT
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Industry
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
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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