Overview
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.
Description
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).
Eligibility
Inclusion Criteria:
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- Signed informed consent form.
- Must have adequate organ function.
Exclusion Criteria:
- Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
- Pregnant or nursing women or women/men who are ready to give birth
- Symptomatic central nervous system metastasis.
- Allergy to other antibody drugs or any excipients in the study drugs.
- Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
- Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.