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

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05145179
Collaborator
(none)
162
1
30

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. DLT [At the end of Cycle 1 (each cycle is 28 days)]

    Dose-limiting toxicity(part 1)

  2. MTD [up to 1 years]

    maximum tolerated dose(part 1)

  3. RP2D [up to 1 years]

    Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose(part 1)

  4. ORR [up to 1 years]

    Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment(part 2)

Secondary Outcome Measures

  1. Adverse events [up to 1 years]

    the safety of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment

  2. Maximum Plasma Concentration (Cmax) [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

  3. Area Under the Curve (AUC) [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

  4. incidence of anti-609A antibodies [up to 1 years]

    incidence of anti-609A antibodies

  5. Median Progression-free Survival (PFS) [up to 1 years]

    The Kaplan-Meier method will be used to estimate median PFS.

  6. Overall Survival (OS) [up to 1 years]

    The Kaplan-Meier method will be used to estimate median OS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05145179
Other Study ID Numbers:
  • SSGJ-705-ST-I-01
First Posted:
Dec 6, 2021
Last Update Posted:
Dec 6, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 6, 2021