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New nanoparticle chemo shows promise in early trial for tough cancers

NCT ID NCT04640480

Disease control Sponsor: SN BioScience Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called SNB-101 in 21 people with advanced solid tumors (like colorectal, breast, and lung cancers) that had stopped responding to standard treatments. SNB-101 is a nanoparticle version of SN-38, the active part of a common chemotherapy drug. The main goals were to check safety, find the right dose, and see how the body processes the drug. The study is now complete.

What this could mean

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

Active substance
SNB-101 (nanoparticle form of SN-38, the active part of the chemotherapy drug irinotecan)
What this could lead to
If successful, this could lead to a better-tolerated version of a common chemotherapy for several advanced cancers.
What could go wrong
This is a very early, small Phase 1 trial focused on safety and dosing, not on proving the drug works. Side effects like low blood counts and liver issues are possible.

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

21 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 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: * Patients with a histologically or cytologically confirmed, locally advanced or metastatic disease, has progressed after systemic standard of care treatment for advanced disease and is not suitable for complete surgical resection. * Patients with measurable or evaluable disease consistent with Response Evaluation Criteria in Solid Tumors version 1.1. * Patients ambulatory with an Eastern Cooperative Oncology Group performance score of 0 or 1. * Patients with adequate hematological, renal, and liver function(CTCAE V5.0 grade 1 or lower). * Patients with the life expectancy of 3 months or longer. Exclusion Criteria: * Patients homozygous for UGT1A1\*28 or UGT1A1\*6 alleles. * Patients known or suspected intolerance or hypersensitivity to main ingredient or any of the excipients of SNB-101. * Patients with unintentional weight loss \>10% within 3 months prior to screening. * Patients who are on dialysis. * Patients who are positive for HIVs. * Patients with a QT interval with Fridericia's correction outside of normal. * Patients with intestinal palsy or bowel obstruction. * Patients with chronic inflammatory bowel disease. * Patients who may require administration of neuromuscular blockers, peripheral muscle relaxants, etc. during the study. * Patients who may require lapatinib during the study. * Patients who may require attenuated vaccine during the study. * Patients who are taking any medication that in the judgement of the investigator could have an effect on the action of SNB-101. * Patients unable to participate in the study as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm head and neck cancer Head and Neck Neoplasms malignant pancreatic neoplasm neoplasm ovarian cancer pancreatic neoplasm small cell lung carcinoma

As listed by the trial registrant

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

Breast cancer Colorectal cancer Gastric cancer Head and neck cancer Ovarian cancer Pancreas cancer Small cell lung cancer

Contacts and locations

Locations

  • CHA Medical Center

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • The Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul, Seoul, 06591, South Korea

  • The Severance Hospital of the Yonsei University

    Seoul, Seoul, 03722, South Korea

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