A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors

Launched by FINDCURE BIOSCIENCES (ZHONGSHAN) CO., LTD. · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FC084CSA when used together with another medication, Tislelizumab, in patients who have advanced malignant solid tumors, which are types of cancer that form in various body tissues. The main goal is to find out how safe and effective this combination is. The trial is currently not recruiting participants, but when it starts, it will focus on adults aged 18 to 75 who have solid tumors that are no longer responding to standard treatments.

To be eligible for the trial, participants must have specific types of cancer and must not have had successful treatment with certain therapies before. They should also be in reasonably good health, with major organs functioning well and no serious ongoing side effects from previous treatments. Those who have recently had other treatments, surgeries, or certain complications will not be able to join. If you or someone you know is interested in this trial, it’s important to discuss eligibility with a healthcare provider. Participants can expect close monitoring throughout the study to ensure their safety and to gather important information about how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 75 years old male and female.
• • 2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
• • 3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
• • 4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
• • 5. According to RECIST 1.1, there is at least one measurable lesion.
• • 6. ECOG performance status 0-1.
• • 7. Major organs are functioning well.
• Exclusion Criteria:
• • 1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
• • 2. Received anti-tumor therapy within 4 weeks before enrollment.
• • 3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
• • 4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
• • 5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
• • 6. Central nervous system metastases with clinical symptoms.
• • 7. With any situations that the researcher considers inappropriate to participate in this research.