This study is testing whether adding three drugs, All-Trans Retinoic Acid (ATRA), SDK002 (also called Arsenic Trioxide or ATO), and tislelizumab, to standard chemotherapy is safe for people with advanced pancreatic cancer. Advanced pancreatic cancer means the cancer has spread or cannot be removed with surgery. The study will also look at whether this treatment combination may help people live longer.
Participants will receive standard chemotherapy drugs, gemcitabine and nab-paclitaxel, together with ATRA, SDK002, and tislelizumab. ATRA is related to vitamin A and may affect how cancer cells grow. SDK002 is a drug used to treat sine cancers and may help other treatments work better. Tislelizumab is an immunotherapy drug, which helps the immune system recognize and attack cancer cells. This is a phase 1 study, which means the main goal is to test safety and side effects. All participants receive the same treatment, and both the study doctors and participants know which drugs are being given.
Participants must have previously untreated unresectable/ metastatic PDAC, without plans for a curative surgery, previous neoadjuvant therapy with 5-FU based therapy is permitted but neoadjuvant gemcitabine-based therapy must have been completed at least 6-months prior to enrollment without documented progression while on gemcitabine. Unresectable PDAC is determined based surgical assessment deeming that curative resection is not foreseeable or appropriate.
Participants should have adequate archival tissue (from primary or metastatic tumour) available and must have provided informed consent for the release of this tissue. For potential participants who do not have adequate residual tissue or a biopsy which was only suspicious for adenocarcinoma approval from the sponsor prior to enrollment is required.
Participants must be ≥ 18 years of age.
Participants must have an ECOG performance status of 0 to 2.
Participants with any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled vomiting.
Participants with a history of other malignancies, except adequately treated non-melanoma skin cancer and low-grade prostate cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 2 years.
Participants may not receive concurrent treatment with other anti-cancer therapy (other than bone-targeted therapy, GnRH agonist/antagonist, or adjuvant tamoxifen and aromatase inhibitors if already taking and stable) or investigational agents while on protocol therapy. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Participants with history of allogeneic organ transplantation.
Single group
ATRA
DrugOrally administered all-trans retinoic acid (ATRA) for up to 6 cycles in combination with chemotherapy and immunotherapy.
Arsenic Trioxide (ATO)
DrugOrally administered SDK002 for up to 6 cycles in combination with chemotherapy and immunotherapy.
Gemcitabine
DrugStandard intravenous chemotherapy, administered per protocol.
Nab-paclitaxel
DrugStandard intravenous chemotherapy, administered per protocol.
Tislelizumab
DrugAnti-PD-1 immune checkpoint inhibitor, administered intravenously for up to 26 cycles.
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Safety will be evaluated by the incidence of adverse events (AEs), including serious adverse events (SAEs), grade 3 and 4 adverse events, adverse events of all grades, and adverse events leading to the discontinuation of study medication. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Safety outcomes will be analyzed using descriptive analyses, including the number and percentage of participants with AEs, SAEs, deaths, adverse events leading to treatment discontinuation, and adverse events by severity and relatedness. Adverse events will be summarized by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA). Clinically significant changes in vital signs and clinical laboratory results will be summarized descriptively, and shift tables will be provided showing change in CTCAE grade from baseline to worst post-baseline grade.
6-Month Progression-Free Survival Rate
The 6-month progression-free survival (PFS) rate is defined as the proportion of participants who remain alive and progression-free at 6 months from the start of study treatment. Tumour progression will be assessed by the site radiologist and/or investigator using iRECIST v1.1 criteria.
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Daniel Breadner
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
BeiGene (Canada) ULC
Collaborator
SDK Therapeutics, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
