Clinical trial NCT06944444: A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
Official title: A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Malignant Tumors
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: DLTs
timeFrame: 21 days
measure: Safety and tolerability
timeFrame: during the intervention，Within 28 days of the last dose
measure: MTD and RP2D
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Cmax of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: Tmax of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: AUC0-last of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: RO of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: Pharmacodynamic (PD) characteristics of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: Immunogenicity of SSS59
timeFrame: baseline, during the intervention and at the end of the study
measure: Preliminary antitumor activity of SSS59
timeFrame: baseline, during the intervention and at the end of the study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
References: