A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors

November 25, 2021 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

A Phase I, Multicenter, Open-Label, First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors

The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 year, male or female.
  • Life expectancy ≥12 weeks (according to Investigator's judgement).
  • Patients with histologically or cytologically confirmed locally advanced or metastatic non resectable HER2-expressing Solid Tumors
  • Patients who have at least one measurable lesion (radiation-naïve) according to RECIST v1.1
  • ECOG performance status 0-1
  • Adequate organ and bone marrow function evaluated by laboratory tests
  • Male patients who are surgically sterilized or who agree to use highly effective contraceptive measures during the study and for at least 6 months after administration of the last study drug dose
  • Willing to provide written informed consent and willing and able to comply with all study procedures.

Exclusion Criteria:

  • Receive chemotherapy, targeted therapy, or other antitumor therapy within 3 weeks prior to initial dosing
  • Patients whose toxicity due to previous anticancer therapy has not been reduced to NCI CTCAE Grade 1 or lower, or any greater than NCI CTCAE 1 AE exists within 2 weeks before enrollment, not including hair loss and fatigue
  • Patients requiring systemic systemic therapy with systemic hormones or other immunosuppressive agents within 4 weeks prior to initial administration and during the study period
  • Previous cumulative doses of adriamycin > 720 mg/m2, adriamycin >360 mg/m2 or other cumulative doses of adriamycin were converted to equal doses of adriamycin >360 mg/m2
  • Patients who underwent major surgery within 4 weeks of initial dosing and have not fully recovered or who plan to undergo major surgery during the trial
  • In addition to palliative radiotherapy, other anticancer treatments not specified in the protocol are planned for the duration of the trial
  • Always received total pelvic radiotherapy
  • Had an active or prior autoimmune or inflammatory disease within the last 3 years prior to study treatment
  • Severe disease of cardiovascular and cerebrovascular diseases
  • History of active tuberculosis
  • A history of (non-infectious) pneumonia/interstitial pneumonia or a history of present pneumonia/interstitial pneumonia requiring steroid treatment
  • Severe dyspnea or the need for supplemental oxygen therapy at rest due to complications of advanced malignancy; Newly diagnosed or symptomatic central nervous system (CNS) metastasis, spinal cord compression, or cancerous meningitis
  • Persons with a history of primary immunodeficiency disease, including but not limited to HIV-positive serum
  • Hepatitis B virus (HBV) and hepatitis C virus (HCV) positive subjects
  • Women/men who are pregnant or breast-feeding or planning to give birth
  • A history of mental or substance abuse that may affect study compliance
  • Allergy to other antibody drugs or to any excipients in the study drug
  • Who received live vaccine within 30 days prior to initial administration (within 72 hours for COVID-19 vaccine), or who plan to receive any live vaccine during the study
  • Previous organ and allogeneic stem cell transplants (except transplants that do not require immunosuppressive therapy, such as corneal and hair transplants)
  • Participated in any medical device or drug clinical study within 1 month prior to screening
  • The inestigators considered that this would significantly increase the risk of administration of the investigational drug, or that it would affect efficacy evaluation or other conditions requiring exclusion

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HER2-expressing Solid Tumors
SSGJ-705 Administered via intravenous (IV) infusion
Drug: SSGJ-705
0.1, 1, 3, 6, 10, 15 or 20mg/kg, IV, Day 1, 8, 15 of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 4 weeks a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Dose-limiting toxicity（part 1）
At the end of Cycle 1 (each cycle is 28 days)
MTD
Time Frame: up to 1 years
maximum tolerated dose（part 1）
up to 1 years
RP2D
Time Frame: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose（part 1）
up to 1 years
ORR
Time Frame: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment（part 2）
up to 1 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 1 years
the safety of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment
up to 1 years
Maximum Plasma Concentration (Cmax)
Time Frame: up to 1 years
To evaluate the Cmax of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
up to 1 years
Area Under the Curve (AUC)
Time Frame: up to 1 years
To evaluate the AUC of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
up to 1 years
incidence of anti-609A antibodies
Time Frame: up to 1 years
incidence of anti-609A antibodies
up to 1 years
Median Progression-free Survival (PFS)
Time Frame: up to 1 years
The Kaplan-Meier method will be used to estimate median PFS.
up to 1 years
Overall Survival (OS)
Time Frame: up to 1 years
The Kaplan-Meier method will be used to estimate median OS.
up to 1 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zefei Jiang, PhD, The Fifth Medical Center of the People's Liberation Army
  • Principal Investigator: Ying Cheng, PhD, Jilin Provincial Cancer Hospital

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSGJ-705-ST-I-01

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

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings