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Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer

NCT07665684 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-06-24

No results posted yet for this study

Summary

The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:

• For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine/nab-paclitaxel?

Participants will:

* Undergo a tumor biopsy.
* Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine/nab-paclitaxel).
* Donate research blood samples.

Conditions

  • Pancreas Ductal Adenocarcinoma
  • Pancreas Cancer, Metastatic
  • Pancreatic Adenocarcinoma Metastatic
  • Adenosquamous Carcinoma of the Pancreas
  • Mucinous Adenocarcinoma

Interventions

DRUG

Samuraciclib + Gemcitabine & Nab-Paclitaxel

Starting dose level: Samuraciclib 240 mg taken orally, once daily. Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

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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 NCT07665684 on ClinicalTrials.gov