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Trial Title:
Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
NCT ID:
NCT06533605
Condition:
Advanced Solid Tumors Patients
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-706
Description:
Bispecific antibody
Arm group label:
Arm 1
Arm group label:
Arm 10
Arm group label:
Arm 11
Arm group label:
Arm 12
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 4
Arm group label:
Arm 5
Arm group label:
Arm 6
Arm group label:
Arm 7
Arm group label:
Arm 8
Arm group label:
Arm 9
Summary:
This study includes two parts, different part has different administration frequencies of
SSGJ-706.
Detailed description:
This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study
includes two parts, different part has different administration frequencies of SSGJ-706.
Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the
preset several dose levels of SSGJ-706 in advanced Solid Tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males and/or females over age 18
2. Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
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-706 The above information
was not intended to contain all considerations relevant to a participant's potential
participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533605
