Locally Advanced, Recurrent or Metastatic Malignancies
Conditions
Keywords
advanced malignancies
Brief summary
This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
Detailed description
This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).
Interventions
DRUGSSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>3 months. 5. Signed informed consent form. 6. Must have adequate organ function.
Exclusion criteria
1. Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. 2. Pregnant or nursing women or women/men who are ready to give birth 3. Symptomatic central nervous system metastasis. 4. Allergy to other antibody drugs or any excipients in the study drugs. 5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy. 6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) . The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D | up to 1 year | the recommended phase II dose |
| DLTs | 14 days | Dose limiting toxicity |
| AE | up to 1 year | Safety and tolerability assessed by incidence and severity of adverse events |
| MTD or MAD | up to 1 year | maximum tolerated dose or the maximum administered dose if MTD is not reached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 1 year | Objective response rate |
| PFS | up to 1 year | Progression-free Survival |
| Cmax | up to 1 year | Maximum Plasma Concentration |
| T1/2 | up to 1 year | Half-life |
Countries
China
Contacts
Primary ContactJinming Yu, MD,Ph.D
Backup ContactYuping Sun, MD,Ph.D
Outcome results
None listed