ATRA + SDK002 + Tislelizumab for Pancreatic Cancer
(ATARI-PDAC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for advanced pancreatic cancer, involving three drugs: ATRA (related to vitamin A), SDK002 (also known as Arsenic Trioxide), and tislelizumab (an immunotherapy). The main goal is to determine if this combination is safe when added to standard chemotherapy and if it might extend survival. Participants should have pancreatic cancer that cannot be surgically removed or has spread, and they should not have received prior chemotherapy for this stage of the disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination.
Is there any evidence suggesting that this treatment combination is likely to be safe for humans?
Research has shown that combining All-Trans Retinoic Acid (ATRA) with chemotherapy is generally safe for patients with pancreatic cancer. Studies have found that adding ATRA to standard chemotherapy does not cause major safety issues, and patients typically tolerate this combination well.
For SDK002, researchers are closely monitoring its combination with chemotherapy to ensure safety. Although specific side effects are not listed, the study focuses on finding the safest dose, indicating careful management of any potential side effects.
Tislelizumab, the immunotherapy drug in this trial, has been widely studied in other cancer treatments. Common side effects include rash and itching, but these are usually manageable. Tislelizumab has already received approval for other cancers, which supports its potential safety.
This trial is in the early stages, with the primary goal of assessing safety. While these treatments show promise, their complete safety profile is still under careful study.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for pancreatic cancer, which often rely on chemotherapy drugs like gemcitabine and nab-paclitaxel, this new combination therapy introduces Tislelizumab, an immune checkpoint inhibitor that helps the body's immune system better recognize and attack cancer cells. Additionally, ATRA (all-trans retinoic acid) is used to modify cancer cell behavior, and SDK002 is a novel compound that might enhance the overall treatment effect. Researchers are excited because this combination targets the cancer from multiple angles, potentially improving outcomes compared to existing therapies.
What evidence suggests that this treatment might be an effective treatment for advanced pancreatic cancer?
Research shows that all-trans retinoic acid (ATRA), one of the treatments in this trial, can make pancreatic cancer cells more responsive to chemotherapy. In one study, 46.7% of patients responded positively to ATRA treatment. ATRA also slows the growth of cancer cells. SDK002, also known as arsenic trioxide, may enhance treatment effectiveness by increasing cancer cells' sensitivity to therapy. Tislelizumab, an immunotherapy drug in this trial, helps the immune system identify and attack cancer cells. In some cases, it has helped patients with pancreatic cancer achieve long-term remission. Together, these drugs have shown promise in improving treatment outcomes for advanced pancreatic cancer.46789
Who Is on the Research Team?
Daniel Breadner
Principal Investigator
London Health Sciences Centre Research Institute
Are You a Good Fit for This Trial?
This trial is for individuals with advanced pancreatic cancer, where the disease has spread or can't be surgically removed. Participants will receive a combination of standard chemotherapy and new drugs. Key eligibility details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ATRA, SDK002, gemcitabine, nab-paclitaxel, and tislelizumab. Treatment continues for a maximum of 6 cycles or until progression or unacceptable toxicity.
Safety Follow-up
Participants return for a Safety Follow-up Visit 28 (± 7) days after the end of the last cycle.
Survival Follow-up
Participants who experience disease progression/relapse will enter Survival Follow-up and be contacted every 3 months for late onset immune related AEs, then every 6 months until death.
What Are the Treatments Tested in This Trial?
Interventions
- ATRA
- SDK002
- Tislelizumab
Trial Overview
The study tests adding ATRA (related to vitamin A), SDK002 (Arsenic Trioxide), and tislelizumab (an immunotherapy drug) to standard chemo drugs gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer, aiming to improve survival rates.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel Breadner
Lead Sponsor
SDK Therapeutics, Inc.
Industry Sponsor
BeiGene (Canada) ULC
Collaborator
Citations
Phase I clinical trial repurposing all-trans retinoic acid as a ...
There was progression for 6.7% (95% CI: 0.2–31.9%) and response in 46.7% (95% CI: 21.3–73.4%) of patients. c Post hoc (including data from ...
ATRA mechanically reprograms pancreatic stellate cells to ...
Here we report that ATRA, an active metabolite of vitamin A, restores mechanical quiescence in PSCs via a mechanism involving a retinoic acid ...
Preliminary results of the efficacy and safety of all-trans ...
Among patients with SD, 12 (75%) showed tumor shrinkage (3%-28%) and 1 (6%) showed minor tumor enlargement (2%). The median follow-up time was ...
Antitumor effects of all-trans retinoic acid and its synergism ...
These results suggested that ATRA sensitized both WT and GR pancreatic cancer cells to gemcitabine and that the combination treatment was synergistic. Open in ...
All-trans retinoic acid inhibits the cell proliferation but ...
The growth-inhibitory effect of ATRA was found when the cells were cultured with 5 μM ATRA for 3 days. In cell scattering assay, ATRA-treated pancreatic cancer ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07348107?aggFilters=status%3A%2CfunderType%3AindustryATRA and SDK002 in Combination With Chemotherapy ...
This is a Phase 1, open-label, single center study to evaluate the safety of ATRA and SDK002 when given with gemcitabine, nab-paclitaxel and ...
Safety and tolerability of all-trans-retinoic acid ...
Conclusions: ATRA combined with bevacizumab and atezolizumab demonstrates a manageable safety profile in patients with refractory MSS mCRC, with ...
Phase I clinical trial repurposing all-trans retinoic acid as a ...
Pre-clinical models have shown that targeting pancreatic stellate cells with all-trans-retinoic-acid (ATRA) reprograms pancreatic stroma to ...
Phase I clinical trial repurposing all trans retinoic acid ( ...
Conclusions: Addition of ATRA as a stromal targeting agent to G-nP combination therapy is safe, tolerable. G-nP-ATRA will now be explored in a phase II ...
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