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

NCT05145179 | Unknown Phase 1 DMC

• 1 other identifier: SSGJ-705-ST-I-01
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Receptor, ErbB-2

Outcome Measures

Primary Outcomes (4)

• DLT

  Dose-limiting toxicity（part 1）

  At the end of Cycle 1 (each cycle is 28 days)

• MTD

  maximum tolerated dose（part 1）

  up to 1 years

• RP2D

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

  up to 1 years

• ORR

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

  up to 1 years

Secondary Outcomes (6)

• Adverse events

  up to 1 years

• Maximum Plasma Concentration (Cmax)

  up to 1 years

• Area Under the Curve (AUC)

  up to 1 years

• incidence of anti-609A antibodies

  up to 1 years

• Median Progression-free Survival (PFS)

  up to 1 years

Study Arms (1)

HER2-expressing Solid Tumors

EXPERIMENTAL

SSGJ-705 Administered via intravenous (IV) infusion

Drug: SSGJ-705

Interventions

SSGJ-705 DRUG

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.

HER2-expressing Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Officials

• Zefei Jiang, PhD

  The Fifth Medical Center of the People's Liberation Army

  PRINCIPAL INVESTIGATOR

• Ying Cheng, PhD

  Jilin Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Zheng, PMD

CONTACT

18511272561; zhenglili@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 6, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: December 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share