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

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInxMed (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IN10018

    Drug

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

  • Albumin-Bound Paclitaxel

    Drug

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

  • Gemcitabine

    Drug

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

  • KN046

    Drug

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)Experimental treatment 3 interventions
Group B: Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
1 year
2

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.

Time frame
2 years

Secondary outcomes

1

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

Proportion of subjects who have CR, PR, or stable disease (SD).

Time frame
1 year
2

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

Available for subjects who demonstrate CR or PR, DoR is defined as the time from the first evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by the investigator.

Time frame
1 years
3

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

Defined as the time from the first day of study treatment to the first disease progression or death due to any cause, whichever occurs first.

Time frame
1 years
4

Overall survival (OS)

Defined as the time from the first day of study treatment to death due to any cause.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InxMed (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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