| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07348107 | ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma. | PHASE1 | NOT YET_RECRUITING | 10 | — | — | Feb 15, 2026 | Mar 1, 2027 | Jan 16, 2026 | 1 | Canada |
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...