NCT06944444 A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
| NCT ID | NCT06944444 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. |
| Condition | Malignant Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-04-27 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 154 participants in total. It began in 2025-04-27 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06944444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Malignant Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06944444 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06944444 currently recruiting?
Yes, NCT06944444 is actively recruiting participants. Contact the research team at Leeqi2001@hotmail.com for enrollment information.
Where is the NCT06944444 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06944444 clinical trial?
NCT06944444 is sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. The trial plans to enroll 154 participants.