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
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
Treatments tested in this trial
- IN10018
- Albumin-Bound Paclitaxel
- Gemcitabine
- KN046
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov