Clinical Trials in China / NCT06499350
Recruiting
Phase 1/2
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
NCT06499350 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Malignant Solid Tumors
Investigational drug(s) / intervention(s)
FC084CSA+Tislelizumab combination (dose escalation)RP2D of FC084CSA+Tislelizumab combination (dose expansion) →
FC084CSA+Tislelizumab combination (dose escalation): Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
RP2D of FC084CSA+Tislelizumab combination (dose expansion): RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Study summary
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
Eligibility
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.
Primary outcome measure(s)
- Determine the Maximum Tolerated Dose (MTD) — Approximately 8 months
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee. - Determine the Recommended Phase 2 Dose (RP2D) — Approximately 8 months
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD. - Determine dose-limiting toxicity (DLT) — 21 days after first dose
Determine the DLT of FC084CSA - Objective response rate (ORR) — Approximately 12 months
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | Recruiting |
More FindCure Biosciences (ZhongShan) Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06499350 on ClinicalTrials.gov ↗ ← All trials in China