Testing SSS59 for advanced malignant tumors
A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
PHASE1 · Shenyang Sunshine Pharmaceutical Co., LTD. · NCT06944444
This study is testing a new treatment called SSS59 to see if it is safe and effective for people with advanced cancer.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. (industry) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06944444 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically documented advanced or recurrent malignant tumors and an ECOG performance status of 0-1.
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.
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 performed: Other studies have shown promise with similar monotherapy approaches in advanced malignancies, but the specific efficacy of SSS59 remains to be established.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai First People's Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Qi Li, MD
- Email: Leeqi2001@hotmail.com
- Phone: 86+13818207333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Tumors