Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATRA · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | ATRA - 45mg/m2, oral, daily SDK002 - 10mg, oral, daily Gemcitabine - 800mg/m2, IV, Days 1, 8, 15 of a 28 day cycle Nab-paclitaxel - 125mg/m2, IV, Days 1, 8, 15 of a 28 day cycle Tislelizumab - 300mg, IV, Day 1 of a 28 day cycle |
| Name | Type | Description |
|---|---|---|
| ATRA | DRUG | Orally administered all-trans retinoic acid (ATRA) for up to 6 cycles in combination with chemotherapy and immunotherapy. |
| Arsenic Trioxide (ATO) | DRUG | Orally administered SDK002 for up to 6 cycles in combination with chemotherapy and immunotherapy. |
| Gemcitabine | DRUG | Standard intravenous chemotherapy, administered per protocol. |
| Nab-paclitaxel | DRUG | Standard intravenous chemotherapy, administered per protocol. |
| Tislelizumab | DRUG | Anti-PD-1 immune checkpoint inhibitor, administered intravenously for up to 26 cycles. |
Inclusion Criteria * 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 enrol...
ATRA is an investigational small molecule being studied for the treatment of Advanced Pancreatic Ductal Adenocarcinoma. It is being evaluated in combination with SDK002, chemotherapy, and an anti-PD-1 inhibitor in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.
ATRA is being developed by BeOne Medicines Ltd., a biopharmaceutical company traded under the ticker ONC. The company is conducting a Phase 1 clinical trial of ATRA in combination with other agents for Advanced Pancreatic Ductal Adenocarcinoma.
ATRA is in Phase 1 clinical development. It is being studied in an open-label, uncontrolled trial for Advanced Pancreatic Ductal Adenocarcinoma. The drug is investigational and has not been approved by regulatory authorities.
ATRA is being evaluated in clinical trial NCT07348107, titled 'ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.' This Phase 1 study is not yet recruiting and plans to enroll 10 participants in Canada.
No, ATRA and SDK002 are distinct agents being studied together in combination. The clinical trial NCT07348107 evaluates ATRA and SDK002 in combination with chemotherapy and an anti-PD-1 inhibitor for Advanced Pancreatic Ductal Adenocarcinoma.