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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Shanghai First People's Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shenyang Sunshine Pharmaceutical Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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