A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)

NCT07761429 | Recruiting Phase 2 DMC

• 1 other identifier: NTP-F520-601
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Unknown Primary Site

Keywords

F520; CUP

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRC

  Progression-Free Survival (PFS) assessed by Independent Review Committee (IRC) based on RECIST 1.1

  2years

Secondary Outcomes (4)

• OS

  2years

• DOR

  2years

• TTR

  2years

• Evaluate the safety of the drug according to CTCAE v6.0

  2years

Study Arms (2)

Arm 1

EXPERIMENTAL

F520 200 mg per dose, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel 175 mg/m²,Q3W. Carboplatin: AUC 5, Q3W.

Drug: F520 combined with chemotherapy

Arm 2

PLACEBO COMPARATOR

placebo 200 mg per dose, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel 175 mg/m²,Q3W. Carboplatin: AUC 5, Q3W.

Drug: placebo combined with chemotherapy

Interventions

F520 combined with chemotherapy DRUG

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.

Arm 1

placebo combined with chemotherapy DRUG

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.

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Shanghai tumor hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

guo zhi luo, doctoral degree

CONTACT

852 13916860586; luozhiguo88@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: August 12, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)