NCT06390774 A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
| NCT ID | NCT06390774 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
| Condition | Locally Advanced, Recurrent or Metastatic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2026-12 |
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 180 participants in total. It began in 2024-05-30 with a primary completion date of 2026-12.
⚠ 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, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
Eligibility Criteria
Inclusion Criteria: 1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>3 months. 5. Signed informed consent form. 6. Must have adequate organ function. Exclusion Criteria: 1. Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. 2. Pregnant or nursing women or women/men who are ready to give birth 3. Symptomatic central nervous system metastasis. 4. Allergy to other antibody drugs or any excipients in the study drugs. 5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy. 6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) . 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 NCT06390774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced, Recurrent or Metastatic Malignancies. 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 NCT06390774 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 NCT06390774 currently recruiting?
Yes, NCT06390774 is actively recruiting participants. Contact the research team at sdyujinming@126.com for enrollment information.
Where is the NCT06390774 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06390774 clinical trial?
NCT06390774 is sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. The trial plans to enroll 180 participants.