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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Advanced Solid Tumors Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

dose level 1 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 2

dose level 2 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 3

dose level 3 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 4

dose level 4 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 5

dose level 5 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 6

dose level 6 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 7

dose level 1 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 8

dose level 2 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 9

dose level 3 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 10

dose level 4 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 11

dose level 5 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Arm 12

dose level 6 of SSGJ-706

Group Type EXPERIMENTAL

SSGJ-706

Intervention Type DRUG

Bispecific antibody

Interventions

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SSGJ-706

Bispecific antibody

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No