MedTrace Logo

ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.

NCT07348107 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

ATRA

Orally administered all-trans retinoic acid (ATRA) for up to 6 cycles in combination with chemotherapy and immunotherapy.

DRUG

Arsenic Trioxide (ATO)

Orally administered SDK002 for up to 6 cycles in combination with chemotherapy and immunotherapy.

DRUG

Gemcitabine

Standard intravenous chemotherapy, administered per protocol.

DRUG

Nab-paclitaxel

Standard intravenous chemotherapy, administered per protocol.

DRUG

Tislelizumab

Anti-PD-1 immune checkpoint inhibitor, administered intravenously for up to 26 cycles.

Sponsors & Collaborators

  • BeiGene (Canada) ULC

    collaborator UNKNOWN

  • SDK Therapeutics, Inc.

    collaborator INDUSTRY

  • Daniel Breadner

    lead OTHER

Principal Investigators

  • Daniel Breadner · London Health Sciences Centre Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348107 on ClinicalTrials.gov