FC084CSA combined with tislelizumab for advanced solid tumors

Is this trial a fit for you?

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 Ib/IIa study uses a 3+3 dose-escalation design to establish the recommended Phase 2 dose (RP2D) of FC084CSA given with a fixed dose of tislelizumab and to characterize safety, tolerability, and pharmacokinetics. After dose escalation, a phase IIa dose-expansion cohort will treat patients at the RP2D to observe preliminary antitumor activity. Eligible patients include adults with advanced malignant solid tumors who have failed standard therapy, with a focused expansion for advanced NSCLC without actionable mutations who previously failed PD‑1/PD‑L1 plus platinum therapy. Key assessments include adverse events, pharmacokinetic sampling, and tumor response measured by RECIST 1.1.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Caicun Zhou — Shanghai East Hospital
• Study coordinator: Tingjin Wang
• Email: wangtingjin@find-cure.com
• Phone: 18664044814

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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.