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Colorectal CancerPhase 1NCT04640480

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

A Phase 1 study testing SNB-101 in people with Colorectal Cancer and Breast Cancer, run by SN BioScience at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colorectal Cancer, Breast Cancer, Pancreas Cancer
What is being tested?
SNB-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesSouth Korea
Study dates
21 Oct 2020to 5 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • CHA Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • The Severance Hospital of the Yonsei University

    Seoul, Seoul, 03722

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

    Seoul, Seoul, 06591

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
SNB-101
Keywords
solid tumors
Medical subject headings
Colorectal Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Small Cell Lung Carcinoma, Stomach Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNB-101Drug

    Also called SN-38

    SN-38 dosage ranges from 1 to 7 will be determined by Safety Review Committee meeting

Study groups in NCT04640480
Study groupRoleWhat they receive
Cohort 1ExperimentalSNB-101 5/8mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 2ExperimentalSNB-101 10/16mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 3ExperimentalSNB-101 20/32mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 4ExperimentalSNB-101 30/48mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 5ExperimentalSNB-101 40/64mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 6ExperimentalSNB-101 45/72mg/m2 Q2W IV
Receives: Drug: SNB-101
Cohort 7ExperimentalSNB-101 50/80mg/m2 Q2W IV
Receives: Drug: SNB-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity(DLT)

    • 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
    1. Nonhematological toxicity
    • Any ≥ grade 3 nonhematological toxicity
    1. 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
    3. Any toxicity related to SNB-101 that results in a treatment delay of more than 2 weeks.

    Measured: up to 18 months(depending on safety variable)

  2. Permanent discontinuation of SNB-101 and dose reduction due to adverse events(AEs)

    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

    Measured: up to 18 months(depending on safety variable)

  3. Number of participants with clinically meaningful changes in Laboratory test results from baseline

    • 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

    Measured: up to 18 months(depending on safety variable)

  4. Number of participants with clinically meaningful changes in Vital signs from baseline

    • 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

    Measured: up to 18 months(depending on safety variable)

  5. Electrocardiogram(ECG) results

    • 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

    Measured: up to 18 months(depending on safety variable)

  6. Number of clinically significant Chest radiograph findings(chest x-ray, CXR)

    • Number of clinically significant chest radiograph findings from chest x-ray.
    • Descriptive statistics for continuous variables, frequency and percentage for categorical variables

    Measured: up to 18 months(depending on safety variable)

Secondary outcomes (12)

  1. Area under the plasma concentration-time curve(AUC)

    • The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  2. Maximum plasma concentration(Cmax)

    • The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  3. Time to Cmax(Tmax)

    The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  4. Clearance(CL)

    The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  5. Volume of distribution(Vd)

    The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  6. Terminal half-life(t1/2)

    The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  7. Elimination rate constant

    The PK parameter will be calculated for SN-38 based on plasma concentrations measured from the PK blood samples.

    Measured: 4 months

  8. The objective response rate(ORR)

    • 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.

    Measured: up to 18 months(depending on subject cycles)

  9. Disease control rate(DCR)

    • 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.

    Measured: up to 18 months(depending on subject cycles)

  10. Overall survival(OS)

    • 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.

    Measured: up to 18 months(depending on subject cycles)

  11. Progression-free survival(PFS)

    • 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.

    Measured: up to 18 months(depending on subject cycles)

  12. Time to progression(TTP)

    • 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.

    Measured: up to 18 months(depending on subject cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start21 Oct 2020
  3. Primary completion5 Jan 2026
  4. Study completion5 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
1-7 cohorts, dose escalation method according to modified accelerated titration design
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640480
Sponsor's protocol ID
SNB-101-101
Status last verified
Jan 2026
First submitted
22 Oct 2020
Last updated
27 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SNB-101 in people with Colorectal Cancer and Breast Cancer, run by SN BioScience at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) (time frame: up to 18 months(depending on safety variable)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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