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Trial Title:
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
NCT ID:
NCT06499350
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
FC084CSA in combination with Tislelizumab
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FC084CSA+Tislelizumab combination (dose escalation)
Description:
Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
Arm group label:
FC084CSA+Tislelizumab
Other name:
FC084CSA+BGB-A317 combination (dose escalation)
Intervention type:
Drug
Intervention name:
RP2D of FC084CSA+Tislelizumab combination (dose expansion)
Description:
RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Arm group label:
FC084CSA+Tislelizumab
Other name:
RP2D of FC084CSA+BGB-A317 combination (dose expansion)
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.
Detailed description:
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess
safety and tolerability of increasing dose levels of FC084CSA in combination of fixed
dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the
preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of
Tislelizumab.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Contact:
Last name:
Caicun Zhou
Phone:
13301825532
Email:
caicunzhoudr@163.com
Start date:
November 10, 2024
Completion date:
September 1, 2026
Lead sponsor:
Agency:
FindCure Biosciences (ZhongShan) Co., Ltd.
Agency class:
Industry
Source:
FindCure Biosciences (ZhongShan) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06499350
