Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors

January 23, 2026 updated by: SN BioScience

A Phase I, Open-Label, Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Infused SNB-101(as SN-38) in Patients With Advanced Solid Tumors

SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in participants with advanced solid tumors. Dose escalation will occur using a modified accelerated titration design (ATD).

All participants will receive SNB 101 in different cohorts. SNB 101 will be administered intravenously to participants on day 1 and day 15 of each 28 day treatment cycle until progressive disease, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.

A Safety Review Committee will determine dose escalation, de-escalation, and modification and the MTD/RP2D based on DLTs and other safety information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each participant will undergo a screening period, a treatment period, and a follow-up period. Participants will be followed until death, withdrawal of consent, or end of study, whichever occurs first.

During the treatment period, participants will receive SNB-101 (dose range: 5 mg/m2 to 50 mg/m2) intravenously on day 1 and day 15 of each 28 day cycle.

Dose reductions are permitted after the DLT observation period, which occurs during the first 28 days of treatment (cycle 1). Participants may permanently or temporarily (at the investigator's discretion) discontinue SNB-101. If a participant experiences a DLT or unacceptable toxicity, SNB-101 treatment should be interrupted until the observed toxicity returns to baseline or ≤ grade 1 toxicity. The start of the next cycle can be delayed up to 2 weeks at the investigator's discretion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • CHA Medical Center
    • Seoul
      • Seoul, Seoul, South Korea, 03722
        • The Severance Hospital of the Yonsei University
      • Seoul, Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
SNB-101 5/8mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 2
SNB-101 10/16mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 3
SNB-101 20/32mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 4
SNB-101 30/48mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 5
SNB-101 40/64mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 6
SNB-101 45/72mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38
Experimental: Cohort 7
SNB-101 50/80mg/m2 Q2W IV
Drug: SNB-101
SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting
Other Names:
  • SN-38

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity(DLT)
Time Frame: up to 18 months(depending on safety variable)
  • All participants who take at least 1 dose of SNB-101 will be assessed.

  • DLTs will be presented by dose group and the MTD determined.

    *DLTs :

    1) Hematological toxicity

  • Grade 4 thrombocytopenia
  • Grade 3 thrombocytopenia with clinically significant bleeding
  • Grade 4 neutropenia lasting > 7 days

  • ≥ grade 3 febrile neutropenia

    2) Nonhematological toxicity

  • Any ≥ grade 3 nonhematological toxicity

    3) Liver function abnormalities

  • Patients who have bone or liver metastasis with the following increases will be considered a DLT:

    1. Baseline AST or ALT = 2.5 to 5× ULN, then AST or ALT that increases to >8× ULN

    2. Baseline ALP = 2.5 to 5×ULN, then ALP increases to >8×ULN

      4) Any toxicity related to SNB-101 that results in a treatment delay of more than 2 weeks.
up to 18 months(depending on safety variable)
Permanent discontinuation of SNB-101 and dose reduction due to adverse events(AEs)
Time Frame: up to 18 months(depending on safety variable)

Definition of permanent discontinuation of SNB-101:

  1. Experiencing a DLT or intolerable toxicity during the DLT observation period.
  2. Experiencing life-threatening Grade 4 adverse events (AE).

  3. Experiencing Grade 2 interstitial lung disease or Grade 4 infusion related reaction/ hypersensitivity.

    • Descriptive statistics for continuous variables, frequency and percentage for categorical variables
up to 18 months(depending on safety variable)
Number of participants with clinically meaningful changes in Laboratory test results from baseline
Time Frame: up to 18 months(depending on safety variable)
  • Hematology: RBC count, WBC count, hemoglobin, hematocrit, platelets, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, WBC differential count, ANC.
  • Serum biochemistry: BUN, creatinine, glucose (random), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, total protein, albumin, Ca, P, K, Na, Cl, CO2, GGT, and LDH.
  • Coagulation: prothrombin time and international normalized ratio.
  • Viral serology: viral serology test for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody. The test can be waived for participants who have results within 28 days prior to screening.
  • Urinalysis: specific gravity, protein, pH, blood, and ketones.
  • Descriptive statistics for continuous variables, frequency and percentage for categorical variables
up to 18 months(depending on safety variable)
Number of participants with clinically meaningful changes in Vital signs from baseline
Time Frame: up to 18 months(depending on safety variable)
  • Vital signs include blood pressure(sitSBP/sitDBP), heart rate, respiratory rate, and body temperature. Change from baseline or previous visit will be described.
  • After each infusion of SNB-101, vital signs will be monitored every 30 minutes for 3 hours on an outpatient basis.
  • Descriptive statistics for continuous variables, frequency and percentage for categorical variables
up to 18 months(depending on safety variable)
Electrocardiogram(ECG) results
Time Frame: up to 18 months(depending on safety variable)
  • ECG data will be collected at screening, C1D1, C3D1 and EOT.
  • ECG measurement at C1D1 and C3D1 will be performed after PK sampling at the end of the infusion (90 min.), 2.5 hours and 24 hours after drug administration.
  • ECG QT interval will be assessed for the safety endpoint(e.g. QTc prolongation)
  • Descriptive statistics for continuous variables, frequency and percentage for categorical variables
up to 18 months(depending on safety variable)
Number of clinically significant Chest radiograph findings(chest x-ray, CXR)
Time Frame: up to 18 months(depending on safety variable)
  • Number of clinically significant chest radiograph findings from chest x-ray.
  • Descriptive statistics for continuous variables, frequency and percentage for categorical variables
up to 18 months(depending on safety variable)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve(AUC)
Time Frame: 4 months
- The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Maximum plasma concentration(Cmax)
Time Frame: 4 months
- The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Time to Cmax(Tmax)
Time Frame: 4 months
The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Clearance(CL)
Time Frame: 4 months
The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Volume of distribution(Vd)
Time Frame: 4 months
The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Terminal half-life(t1/2)
Time Frame: 4 months
The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
Elimination rate constant
Time Frame: 4 months
The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.
4 months
The objective response rate(ORR)
Time Frame: up to 18 months(depending on subject cycles)
  • Determination of the antitumor efficacy of SNB-101
  • All participants who take at least 1 dose of SNB-101 and have at least 1 post dose efficacy assessment will be assessed.
  • Computed tomography scans (abdomen/pelvic, chest) will be performed at screening and every 8 weeks (± 7 days) for tumor assessment.
  • ORR is defined as the percentage of participants who have achieved either complete response or partial response to the therapeutic intervention. Response is measured per RECIST version 1.1 as assessed by the investigator at the local site.
  • ORR will be presented as frequencies and percentages.
up to 18 months(depending on subject cycles)
Disease control rate(DCR)
Time Frame: up to 18 months(depending on subject cycles)
  • Determination of the antitumor efficacy of SNB-101
  • All participants who take at least 1 dose of SNB-101 and have at least 1 post dose efficacy assessment will be assessed.
  • Computed tomography scans (abdomen/pelvic, chest) will be performed at screening and every 8 weeks (± 7 days) for tumor assessment.
  • DCR is defined as the percentage of participants who have achieved either complete response, partial response, or stable disease to the therapeutic intervention. Response is measured per RECIST version 1.1 as assessed by the investigator at the local site.
  • DCR will be presented as frequencies and percentages.
up to 18 months(depending on subject cycles)
Overall survival(OS)
Time Frame: up to 18 months(depending on subject cycles)
  • Determination of the antitumor efficacy of SNB-101
  • All participants who take at least 1 dose of SNB-101 and have at least 1 post dose efficacy assessment will be assessed.
  • Computed tomography scans (abdomen/pelvic, chest) will be performed at screening and every 8 weeks (± 7 days) for tumor assessment.
  • OS is defined as the time from the first dose of SNB-101 to death from any cause.
  • OS median survival times will be calculated using the Kaplan Meier method.
up to 18 months(depending on subject cycles)
Progression-free survival(PFS)
Time Frame: up to 18 months(depending on subject cycles)
  • Determination of the antitumor efficacy of SNB-101
  • All participants who take at least 1 dose of SNB-101 and have at least 1 post dose efficacy assessment will be assessed.
  • Computed tomography scans (abdomen/pelvic, chest) will be performed at screening and every 8 weeks (± 7 days) for tumor assessment.
  • PFS is defined as the time from the first dose of SNB-101 to documented disease progression or death due to any cause, whichever occurs earlier.
  • PFS median survival times will be calculated using the Kaplan Meier method.
up to 18 months(depending on subject cycles)
Time to progression(TTP)
Time Frame: up to 18 months(depending on subject cycles)
  • Determination of the antitumor efficacy of SNB-101
  • All participants who take at least 1 dose of SNB-101 and have at least 1 post dose efficacy assessment will be assessed.
  • Computed tomography scans (abdomen/pelvic, chest) will be performed at screening and every 8 weeks (± 7 days) for tumor assessment.
  • TTP is defined as the time from the first dose of SNB-101 to objective tumor progression.
  • TTP will be calculated using the Kaplan Meier method.
up to 18 months(depending on subject cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SN BioScience

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joohang Kim, Dr, CHA Medical Center at Bundang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNB-101-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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