A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
- Registration Number
- NCT06944444
- Lead Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part A1 SSS59 Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level. Part A2 SSS59 Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level. Part A3 SSS59 Dose extension will be carried out at the selected dose level, Q3W, IV. Part B SSS59 Indication extension will be carried out at the selected level.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cmax of SSS59 baseline, during the intervention and at the end of the study Maximum concentration
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
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
Immunogenicity of SSS59 baseline, during the intervention and at the end of the study ADA，NAB（if ADA is positive）
Preliminary antitumor activity of SSS59 baseline, during the intervention and at the end of the study Assessed according to Recist V1.1
Trial Locations
- Locations (1)
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China