RecruitingPhase 1NCT06390774
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Enrollment
180 participants
Start Date
May 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria7
- 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.
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Interventions
DRUGSSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06390774