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Experimental cocktail takes on toughest pancreatic cancer

NCT ID NCT07348107

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether adding ATRA, SDK002, and an immunotherapy drug to standard chemotherapy is safe for people with advanced pancreatic cancer that cannot be removed by surgery. Ten participants will receive all five drugs together. The study will also track how long they live without the cancer growing. Because it is a phase 1 trial, safety is the main focus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATRA (all-trans retinoic acid), SDK002 (arsenic trioxide), gemcitabine, nab-paclitaxel, and tislelizumab
What this could lead to
If this combination proves safe, it could point toward a new treatment option for advanced pancreatic cancer that may help patients live longer.
What could go wrong
This is a very early phase 1 study with only 10 people, so the main goal is safety, not effectiveness. The combination may cause serious side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 must have a life expectancy of 3 months or longer. * Laboratory requirements (must be done within 7 days prior to enrollment): * Absolute neutrophils: ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks prior to the first study treatment) * Hemoglobin: ≥ 90 × 109/L * Platelets: ≥ 100 × 109/L * Bilirubin: \< 1.5 × ULN (Note: Exceptions may be made if confirmed diagnosis of Gilberts (\< 3 × ULN); ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable * AST and ALT: \< 2.5 × ULN; ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable * ALP: \< 2.5 × ULN; ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable * Serum creatinine and creatinine clearance: ≥ 45 mL/min; (Note: Creatinine clearance to be measured directly by 24-hour urine sampling or as calculated by Cockcroft and Gault equation below: Females: GFR = 1.04 × \[140-age\] × weight in kg / serum creatinine in μmol/L Males: GFR = 1.23 × \[140-age\] × weight in kg / serum creatinine in μmol/) * Participants must be able to swallow oral medications and have no known gastrointestinal disorders that may interfere with absorption (such as malabsorption). * Patients must have received no prior systemic therapy in the first-line setting for unresectable/metastatic disease. * Prior chemotherapy: prior chemotherapy in the adjuvant/neoadjuvant setting is allowed provided \> 6 months from last chemotherapy at time of enrolment for gemcitabine-based therapies, no time restrictions for 5-FU based therapies; patients must have had recovered (to grade 1 or better) from all reversible toxicity related to prior chemotherapy or systemic therapy. * Radiation: Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions include low-dose, non-myelosuppressive radiotherapy to sites outside of the primary disease such as palliative radiation to bone metastases. Concurrent radiotherapy is not permitted. * Surgery: Previous surgery is permitted provided that a minimum of 21 days (3 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred. Stenting, percutaneous cholecystostomy, and endoscopies are permitted. * Interventional Radiology: Prior radioembolization is permitted up to 4 weeks prior to enrolment. Interventional pain control such as celiac axis block allowed prior to treatment. * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to screening (if applicable)/enrollment in the trial to document their willingness to participate. * Participants must be accessible for treatment and follow up. Participants enrolled in this trial must be treated and followed at the participating center. Investigators must assure themselves the participants enrolled in this trial will be available for complete documentation of the treatment, AEs, and follow-up. * Participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. * WOCBP will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin (hCG) is elevated from a possible tumour source. Participants will be considered eligible if an ultrasound is negative for pregnancy. Male participants should also refrain from donating sperm during the study and for 6 months after the last dose of study treatment. -Women must refrain from breastfeeding while on treatment. Exclusion Criteria * 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. * Participants with active autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]) that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * The following autoimmune are exceptions to this criterion: 1) participants with vitiligo or alopecia; 2) participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; 3) participants with any chronic skin condition that does not require systemic therapy; 4) participants with celiac disease controlled by diet alone; 5) participants without an active disease in the last 5 years may be included but only after consultation with the principal investigator. * Current or prior use of immunosuppressive medications within 14 days before first drug dose. * The following are exceptions to this criterion: 1) intranasal, inhaled, or topical steroids or local steroid injections (e.g., intra-articular injection); 2) systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; 3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) or steroids a single oral dose are permitted * History of active primary immunodeficiency. * Participants who have received growth factors within 28 days prior to initiation of dosing of ATRA and SDK002. * Primary prophylaxis not allowed, but secondary prophylaxis is permitted. * Participant has known active, uncontrolled HIV, or hepatitis B or C infection. * Participants with undetectable viral load are eligible. * Participants with serious illnesses which would not permit the participant to be managed according to the protocol. * Uncontrolled intercurrent illness includes but is not limited to: clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the participant to give written informed consent. * Participant deemed by the investigator to be at high cardiovascular risk, specifically including, but not limited to, recent coronary stenting or myocardial infarction in the 6 months before screening, or QTc ≥ 490 ms for males or ≥ 470 ms for females. * Participants with pre-existing sensory neuropathy \> grade 1. * Participants with history of central nervous system metastases or spinal cord compression unless they have received treatment, are clinically stable and do not require corticosteroids. * Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis) are eligible. * Participants are not eligible if they have a known hypersensitivity to the study drug(s) or their components. * Major surgical procedure within 28 days before the first dose of study treatment. * Participants who have received prior immune-mediated therapy, including, but not limited to, other anti-PD-1, anti PD-L1, or anti CTLA-4. * Participant is taking any additional cytotoxic anti-cancer medications, other prohibited concurrent medication, including vitamin A supplements, isotretinoin, and is unwilling to stop use prior to and during the trial. * Participant has received a live vaccine within 4 weeks before receiving their first dose of study treatment. * Participant is unwilling or unable to comply with study procedures, as assessed by the Principal Investigator. * Is pregnant, breastfeeding, or is of reproductive potential and unwilling to comply with contraceptive requirements as described in Appendix 5.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Verspeeten Family Cancer Centre

    London, Ontario, N6A 5W9, Canada

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