FC084CSA combined with tislelizumab for advanced solid tumors

A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors

This trial tests whether adding the experimental drug FC084CSA to the immunotherapy tislelizumab helps adults (18–75) with advanced solid tumors that have progressed after standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Tislelizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06499350 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with histologically or cytologically confirmed advanced solid tumors (and for phase IIa, stage IIIB/IIIC/IV NSCLC without actionable mutations) who have measurable disease per RECIST 1.1, ECOG 0–1, adequate organ function, and prior failure of standard therapies (including prior PD‑1/PD‑L1 plus platinum in the NSCLC expansion).

Not a fit: Patients who have not recovered from prior treatment toxicities (≥ CTCAE grade 1), received anti‑tumor therapy or participated in another investigational trial within 4 weeks, have actionable mutations with approved targeted therapies, poor performance status, or significant comorbidities are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that improves responses and disease control for patients with advanced solid tumors who have limited options.

How similar studies have performed: Other early‑phase studies combining novel agents with PD‑1 inhibitors have shown encouraging signals in some tumor types, but FC084CSA is a novel agent and its combination with tislelizumab is not yet proven.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Caicun Zhou — Shanghai East Hospital
• Study coordinator: Tingjin Wang

Conditions Advanced Malignant Solid Tumors