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

NCT05827796 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • InxMed (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Liwei Wang · Renji Hospital of Shanghai Jiaotong University of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827796 on ClinicalTrials.gov