Cancer of Unknown Primary Site
Conditions
Keywords
F520, CUP
Brief summary
The purpose of this study is to evaluate the efficacy and safety of F520 combined with paclitaxel plus carboplatin as first-line treatment for cancer of unknown primary.This study consists of two parts, with a total planned enrollment of 402 patients.Primary Endpoint is Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) based on RECIST 1.1 Secondary Endpoints included ORR、PFS、DOR；Incidence and severity of Adverse Events (AE), Serious Adverse Events (SAE), and abnormal laboratory parameters.
Interventions
DRUGF520 combined with chemotherapy
F520: 200 mg per dose, intravenous infusion, infusion time \>30 minutes, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel: 175 mg/m², intravenous infusion, infusion time \>3 hours, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details. Carboplatin: AUC 5, intravenous infusion, infusion time \>30 minutes, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details.
Placebo: 200 mg per dose, intravenous infusion, infusion time \>30 minutes, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel: 175 mg/m², intravenous infusion, infusion time \>3 hours, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details. Carboplatin: AUC 5, intravenous infusion, infusion time \>30 minutes, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details.
Sponsors
Shandong New Time Pharmaceutical Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years (inclusive), any gender Histopathologically confirmed adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma of metastatic lesions Diagnosis of CUP after standard evaluation (see Appendix 4) No prior systemic therapy for CUP At least one measurable lesion per RECIST 1.1 criteria Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 Investigator-assessed life expectancy ≥3 months Adequate organ function as follows (no blood products or hematopoietic growth factors within 14 days before first dose): Hematology: ANC ≥1.5×10⁹/L; Platelet count ≥90×10⁹/L; Hemoglobin (Hb) ≥90 g/L Liver Function: AST, ALT ≤2.5×ULN; Total bilirubin (TBIL) ≤1.5×ULN; If liver metastases present: AST and ALT ≤5×ULN, TBIL ≤3×ULN Renal Function: Serum creatinine (Cr) ≤1.25×ULN Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN Understanding of study procedures and content, and voluntary signed informed consent
Exclusion criteria
* CUP patients who, in the investigator's judgment, are candidates for local curative treatment Histopathologically confirmed neuroendocrine carcinoma or germ cell tumor of metastatic lesions Prior genetic testing (including but not limited to NGS) showing NTRK fusion-positive, ALK fusion-positive, EGFR sensitizing mutations, BRAF mutations suitable for molecular targeted therapy, or MSI-H/dMMR Genetic testing (including but not limited to 90-gene assay) suggesting possible colorectal, renal, or breast cancer origin (excluding triple-negative breast cancer) Prior treatment with taxanes, platinum-based chemotherapy, and/or prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1) or any tumor immunotherapy Received chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, or immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment Primary and/or metastatic central nervous system (CNS) malignancies or carcinomatous meningitis Required systemic corticosteroids (equivalent to \>10 mg prednisone/day) or other immunosuppressive drugs within 2 weeks before enrollment or during study. Exception: topical or inhaled corticosteroids, or short-term (≤7 days) corticosteroids for prevention or treatment of non-autoimmune, infrequent allergic diseases Prior anti-tumor treatment-related adverse events not recovered to NCI-CTCAE V5.0 (or later) Grade ≤1 or levels specified in inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by IRC | 2years | Progression-Free Survival (PFS) assessed by Independent Review Committee (IRC) based on RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 2years | Overall survivall（OS） assessed by IRC and researchers based on RECIST 1.1 |
| DOR | 2years | Duration of Response（DOR） assessed by IRC and researchers based on RECIST 1.1 |
| TTR | 2years | Time to Tumor Recurrence（TTR ）assessed by IRC and researchers based on RECIST 1.1 |
| Evaluate the safety of the drug according to CTCAE v6.0 | 2years | Monitor the laboratory test indicators and observe the occurrence of adverse events and serious adverse events. |
Countries
China
Contacts
CONTACTguo zhi luo, doctoral degree
Outcome results
None listed