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
- Registration Number
- NCT05145179
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 162
- ≥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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HER2-expressing Solid Tumors SSGJ-705 SSGJ-705 Administered via intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method DLT At the end of Cycle 1 (each cycle is 28 days) Dose-limiting toxicity（part 1）
MTD up to 1 years maximum tolerated dose（part 1）
RP2D up to 1 years Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose（part 1）
ORR up to 1 years Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment（part 2）
- Secondary Outcome Measures
Name Time Method 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
incidence of anti-609A antibodies up to 1 years incidence of anti-609A antibodies
Overall Survival (OS) up to 1 years The Kaplan-Meier method will be used to estimate median OS.
Median Progression-free Survival (PFS) up to 1 years The Kaplan-Meier method will be used to estimate median PFS.
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
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