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

Sunshine Guojian Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumors Patients

Treatments: Drug: SSGJ-706

Study type: Interventional

Funder types: Industry

Identifiers

NCT06533605

SSGJ-706-101

Details and patient eligibility

About

This study includes two parts, different part has different administration frequencies of SSGJ-706.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 12 patient groups

Arm 1

Experimental group

Description:

dose level 1 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 2

Experimental group

Description:

dose level 2 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 3

Experimental group

Description:

dose level 3 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 4

Experimental group

Description:

dose level 4 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 5

Experimental group

Description:

dose level 5 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 6

Experimental group

Description:

dose level 6 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 7

Experimental group

Description:

dose level 1 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 8

Experimental group

Description:

dose level 2 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 9

Experimental group

Description:

dose level 3 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 10

Experimental group

Description:

dose level 4 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 11

Experimental group

Description:

dose level 5 of SSGJ-706

Treatment:

Drug: SSGJ-706

Arm 12

Experimental group

Description:

dose level 6 of SSGJ-706

Treatment:

Drug: SSGJ-706