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

Trial ID: NCT05827796

Interventional - Phase 1/2 - Recruiting

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

Interventions

• IN10018
• Albumin-Bound Paclitaxel
• Gemcitabine
• KN046

Eligibility

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:
• Not a woman of childbearing potential (WOCBP) . or
• A WOCBP who agrees to follow the contraceptive guidance.

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.
• 11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• 12. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases within 6 months before the first dose of study treatment.
• 13. Active infection with poor systemic treatment control.
• 14. Has known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C (HCV) infection, or active syphilis and tuberculosis.
• 15. 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.

Sponsor

InxMed (Shanghai) Co., Ltd.

Source: ClinicalTrials.gov

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