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Study of SBP-101 with Nab-Paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer

This study is testing a new drug called SBP-101 along with standard chemotherapy (nab-paclitaxel and gemcitabine) for people with metastatic pancreatic cancer. Metastatic means the cancer has spread to other parts of the body. You could join if you have metastatic pancreatic ductal adenocarcinoma that hasn't been treated before, and was diagnosed within the last three months. The study aims to see if adding SBP-101 helps people live longer. About 600 people will participate. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving about 600 participants. This means participants are randomly assigned to receive either SBP-101 or a placebo, and neither you nor your doctors will know which you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from their first dose up to 100 weeks or until death to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05254171

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Panbela Therapeutics, Inc.
~600 participants
Updated 2024-11-06 on ClinicalTrials.gov
What's tested:SBP-101Nab-paclitaxelGemcitabinePlacebo

At a glance

Recruiting sites
77 of 93 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over From date of first dose up to 100 weeks or until death

Conditions

Pancreatic Cancer Metastatic
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Stage IV

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT05254171

Where you'd take part

This study runs at 93 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.ö. Krankenhaus der Barmherzigen Brüder

    Wein, Austriastudy coordinator listed

    Recruiting

  • Asan Medical Center - PPDS

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, Australiastudy coordinator listed

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, Australiastudy coordinator listed

    Recruiting

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, Belgiumstudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Venito, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, Italystudy coordinator listed

    Recruiting

  • Azienda Unita Sanita Locale di Reggio Emilia IRCCS

    Reggio Emilia, Emilia-Romagna, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael J Walker, MD · STUDY_DIRECTOR · Panbela Therapeutics, Inc.

Who to contact

Rachel Bragg, MPH
[email protected]
952-479-1196
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel. Subjects who have had planned or prior surgery, such as a Whipple procedure, with or without neo-adjuvant/or adjuvant chemotherapy may be included.
Life expectancy ≥ 3 months.
Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Adult, age ≥ 18 years, male or female.
Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception from 2 weeks before the first administration of SBP-101 until 6 months after the last administration of study drug (i.e., last dose of any of the three drugs in the regimen). Female subjects are considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, all with surgery at least one month before dosing).
Adequate bone marrow, hepatic and renal function as outlined in protocol.
QTc interval ≤ 470 ms (for women) and ≤ 450 ms (for men) on the ECG at baseline calculated by either the Fridericia or Framingham formula.
Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required.

Exclusion

When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA 1/2 (Breast Cancer gene) are excluded.
Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed).
Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia \[-6.0 diopters or approximately 20/500\], eye surgery \<6 months prior to C1D1, or history of a severe eye injury. Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded.
Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance.
Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
Serum albumin \< 30 g/L (3.0 g/dL).
Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening.
Presence of known active bacterial, fungal, or viral infection requiring systemic therapy.
Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.
Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV.
Pregnant or lactating.
Major surgery within 4 weeks prior to the start of study drug treatment, without complete recovery.
Known hypersensitivity to any component of study treatments.
Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.
Any history of hydroxychloroquine use (Plaquenil® and other brand names).

What this trial measures

  • Overall Survival (OS)From date of first dose up to 100 weeks or until death

    Compare OS between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine