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

NCT05827796 | Recruiting Phase 1 DMC

• 1 other identifier: IN10018-012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Related Adverse Events （AEs）

  Incidence and severity of AEs, with severity determined according to the NationalCancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

  1 year

• To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with advanced pancreatic cancer.

  Proportion of subjects who have the best objective response of either complete response (CR) or partial response (PR), as assessed by the investigator.

  2 years

Secondary Outcomes (5)

• Disease Control Rate (DCR) per RECIST 1.1, as evaluated by investigators

  1 year

• duration of response (DoR) per RECIST 1.1, as evaluated by investigators

  1 years

• Progression free survival (PFS) per RECIST 1.1, as evaluated by investigators

  1 years

• Overall survival (OS)

  2 years

• Incidence of Treatment-Related AEs

  2 years

Study Arms (2)

Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)

EXPERIMENTAL

Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle.

Drug: IN10018; Drug: Albumin-Bound Paclitaxel; Drug: Gemcitabine

Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046

EXPERIMENTAL

Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 2 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 2 and 9 of each 21-Day Cycle+KN046 5 mg/kg IV infusion on Day 1 of each 21-Day Cycle.

Drug: IN10018; Drug: Albumin-Bound Paclitaxel; Drug: Gemcitabine; Drug: KN046

Interventions

IN10018 DRUG

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

Also known as: BI853520

Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine); Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046

Albumin-Bound Paclitaxel DRUG

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

Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine); Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046

Gemcitabine DRUG

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

Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine); Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046

KN046 DRUG

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

Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046

Eligibility Criteria

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

You may qualify if:

• With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.
• Female or male subjects ≥ 18 years at the time of signing informed consent.
• Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
• No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.
• At least one measurable lesion per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months as assessed by the investigator.
• Must have recovered from all AEs due to previous anticancer therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by the investigator. Subjects with any grade of alopecia and grade 2 peripheral neuropathy could be enrolled.
• Adequate bone marrow, liver, renal, and coagulation function .
• A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) . or
• A WOCBP who agrees to follow the contraceptive guidance.

You may not qualify if:

• Has had major surgery or major trauma within 28 days prior to the first dose of study treatment.
• Has known BRCA1/2 mutations.
• Has received prior systemic anticancer therapy including chemotherapy, targeted therapy, immunotherapy, unmarketed investigational drugs or therapy within 28 days prior to the first dose of study treatment.
• Previous anti-programmed death 1(PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or checkpoint pathways, or prior treatment with focal adhesion kinase (FAK) inhibitors.
• Has received radical radiotherapy within 3 months prior to the first dose of study treatment. Subjects who have received palliative radiotherapy with a local standardized dose within 2 weeks prior to the first dose of study treatment.
• Has received previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
• Has received live vaccines and live attenuated vaccines within 28 days prior to the first dose of study treatment.
• Has interstitial pneumonia or lung disease.
• History or current active autoimmune diseases.
• Has a prior history of other malignancy, other than cured cutaneous squamous cell carcinoma, basal cell cancer, non-basal invasive bladder cancer, and prostate/cervical/breast cancer in situ within 5 years prior to the first dose of study treatment.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases within 6 months before the first dose of study treatment.
• Active infection with poor systemic treatment control.
• Has known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C (HCV) infection, or active syphilis and tuberculosis.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (1)

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Liwei Wang

  Renji Hospital of Shanghai Jiaotong University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bohong Zhang

CONTACT

+86 18801955197; bohong.zhang@inxmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 25, 2023
• Study Start: December 8, 2022
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)