A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
NCT ID: NCT06499350
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2024-11-13
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FC084CSA+Tislelizumab
This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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FindCure Biosciences (ZhongShan) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Caicun Zhou
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FC084-CA-102
Identifier Type: -
Identifier Source: org_study_id
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