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Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06533605
Enrollment
60
Registered
2024-08-01
Start date
2024-08-31
Completion date
2025-08-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors Patients

Keywords

Solid Tumors

Brief 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.

Interventions

Bispecific antibody

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
DLTs12 monthsDose limiting toxicity
MTD or MAD12 monthsmaximum tolerated dose or the maximum administered dose if MTD is not reached

Secondary

MeasureTime frameDescription
The blood concentration of SSGJ-70612 monthsPK characteristics

Contacts

Primary ContactHao Chen, MD, Ph.D
chenhao3996913@163.com15009467790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026