Malignant Tumors
Conditions
Brief summary
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
Detailed description
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
Interventions
DRUGSSS59
A humanized antibody targeting MUC17
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival \>3 months. * Signed informed consent form. * Must have adequate organ function.
Exclusion criteria
* Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue. * Pregnant or nursing women or women/men who are ready to give birth. * symptomatic central nervous system metastasis. * Allergy to other antibody drugs or any excipients in the study drugs. * Underwent major surgery within 4 weeks prior to first dosing. * The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study. 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 |
|---|---|---|
| DLTs | 21 days | Dose limiting toxicity |
| Safety and tolerability | during the intervention，Within 28 days of the last dose | Safety and tolerability assessed by incidence and severity of adverse events |
| MTD and RP2D | through study completion, an average of 2 year | Determine the maximum tolerated dose and determine the recommended phase II dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RO of SSS59 | baseline, during the intervention and at the end of the study | Receptor Occupancy |
| Pharmacodynamic (PD) characteristics of SSS59 | baseline, during the intervention and at the end of the study | change of cytokine |
| Cmax of SSS59 | baseline, during the intervention and at the end of the study | Maximum concentration |
| Preliminary antitumor activity of SSS59 | baseline, during the intervention and at the end of the study | Assessed according to Recist V1.1 |
| Immunogenicity of SSS59 | baseline, during the intervention and at the end of the study | ADA，NAB（if ADA is positive） |
| Tmax of SSS59 | baseline, during the intervention and at the end of the study | Time to peak drug concentration |
| AUC0-last of SSS59 | baseline, during the intervention and at the end of the study | the area under the curve (AUC) up to the last measurable concentration |
Countries
China
Contacts
Primary ContactQi Li, MD
Outcome results
None listed