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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors Patients
• Interventions: Drug: SSGJ-706

• Registration Number: NCT06533605
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study Start: 2024-08
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 9	SSGJ-706	dose level 3 of SSGJ-706
Arm 10	SSGJ-706	dose level 4 of SSGJ-706
Arm 2	SSGJ-706	dose level 2 of SSGJ-706
Arm 3	SSGJ-706	dose level 3 of SSGJ-706
Arm 4	SSGJ-706	dose level 4 of SSGJ-706
Arm 5	SSGJ-706	dose level 5 of SSGJ-706
Arm 1	SSGJ-706	dose level 1 of SSGJ-706
Arm 6	SSGJ-706	dose level 6 of SSGJ-706
Arm 8	SSGJ-706	dose level 2 of SSGJ-706
Arm 11	SSGJ-706	dose level 5 of SSGJ-706
Arm 7	SSGJ-706	dose level 1 of SSGJ-706
Arm 12	SSGJ-706	dose level 6 of SSGJ-706

Primary Outcome Measures

Name	Time	Method
MTD or MAD	12 months	maximum tolerated dose or the maximum administered dose if MTD is not reached
DLTs	12 months	Dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
The blood concentration of SSGJ-706	12 months	PK characteristics