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IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT05827796•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.

Detailed Description

This is a multicenter, open-label, single-arm, phase Ib/II clinical study to evaluate the safety, tolerability, and antitumor activities of IN10018 + standard chemotherapy (albumin paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. This study includes two cohorts, Cohort 1: IN10018 + standard chemotherapy; Cohort 2: IN10018 + standard chemotherapy + KN046. Each cohort consists of 2 phases: a dose confirmation phase and a dose expansion phase. The dose confirmation phase aims to determine recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy 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. According to the Package Insert of standard chemotherapy (albumin paclitaxel and gemcitabine), the Investigator's Brochure (IB) and drug characteristics of KN046, it is expected that IN10018 has little possibility of interaction with standard chemotherapy and KN046, and the safety characteristics are clearly non-overlapping. The therapeutic dose of KN046, albumin-bound paclitaxel and gemcitabine are fixed in this study. In the dose confirmation phase, IN10018 dose will be modified according to the causality between dose-limiting toxicities (DLTs) and IN10018.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.
•2. Female or male subjects ≥ 18 years at the time of signing informed consent.
•3. Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
•4. No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.
•5. At least one measurable lesion per RECIST 1.1.
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•7. Life expectancy of at least 3 months as assessed by the investigator.
•8. 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.
•9. Adequate bone marrow, liver, renal, and coagulation function .
•10. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
+2 more criteria

Exclusion Criteria

•1. Has had major surgery or major trauma within 28 days prior to the first dose of study treatment.
•2. Has known BRCA1/2 mutations.
•3. 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.
•4. 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.
•5. 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.
•6. Has received previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
•7. Has received live vaccines and live attenuated vaccines within 28 days prior to the first dose of study treatment.
•8. Has interstitial pneumonia or lung disease.
•9. History or current active autoimmune diseases.
•10. 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.
+5 more criteria

Locations (1)

Renji Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 8, 2022

Primary Completion Date

December 31, 2025

Completion Date

March 31, 2026

Last Updated

April 30, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

IN10018

DRUG

Albumin-Bound Paclitaxel

DRUG

Gemcitabine

DRUG

KN046

DRUG

Contacts

Bohong Zhang

CONTACT

+86 18801955197 bohong.zhang@inxmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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