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

July 29, 2024 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
dose level 1 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 2
dose level 2 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 3
dose level 3 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 4
dose level 4 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 5
dose level 5 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 6
dose level 6 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 7
dose level 1 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 8
dose level 2 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 9
dose level 3 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 10
dose level 4 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 11
dose level 5 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody
Experimental: Arm 12
dose level 6 of SSGJ-706
Drug: SSGJ-706
Bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLTs
Time Frame: 12 months
Dose limiting toxicity
12 months
MTD or MAD
Time Frame: 12 months
maximum tolerated dose or the maximum administered dose if MTD is not reached
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The blood concentration of SSGJ-706
Time Frame: 12 months
PK characteristics
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSGJ-706-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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