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A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

RECRUITINGPhase 1Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.
Actively Recruiting
PhasePhase 1
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
Started2025-04-27
Est. completion2027-03-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions2

CancerMalignant Tumors

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