Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Testing SSS59 for 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

Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT06944444 · Data updated 2026-11-12

This study is testing a new treatment called SSS59 to see if it is safe and effective for people with advanced cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment154 (estimated)
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
Industry-sponsored
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 27, 2025
Main results expectedMarch 1, 2027
Study endsDecember 31, 2027
Registry record updatedApril 29, 2025
Trial IDNCT06944444 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with histologically documented advanced or recurrent malignant tumors and an ECOG performance status of 0-1.

Probably not a fit

Patients with symptomatic central nervous system metastasis or those who have experienced significant adverse effects from prior treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase I study evaluates the safety, pharmacokinetics, and antitumor activity of SSS59 as a monotherapy in patients with advanced malignancies. The study is divided into four parts: dose escalation and extension for different administration schedules, and an indication extension for specific types of advanced tumors. Participants will receive SSS59 to determine its effectiveness and safety profile in treating their conditions.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors who have limited treatment alternatives.

How similar studies have gone: Other studies have shown promise with similar monotherapy approaches in advanced malignancies, but the specific efficacy of SSS59 remains to be established.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Shanghai First People's Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.