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RECRUITING
NCT05827796
PHASE1/PHASE2

IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer

Sponsor: InxMed (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.

Official title: A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-12-08

Completion Date

2026-03-31

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DRUG

IN10018

IN10018 orally once daily at approximately the same time each day, to ensure a dosing interval of approximately 24 hours.

DRUG

Albumin-Bound Paclitaxel

Albumin-bound paclitaxel will be administered as per the schedule specified in the respective arm.

DRUG

Gemcitabine

Gemcitabine will be administered as per the schedule specified in the respective arm.

DRUG

KN046

KN046 5 mg/kg on Day 1 of each 21-Day Cycle.

Locations (1)

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China