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Colorectal Cancer MetastaticPhase 1/2NCT04368507

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of YYB101 With Irinotecan, Patients Who Are Metastatic or Recurrent Colorectal Cancer Patients

A Phase 1/2 study testing YYB101 in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by CellabMED 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

To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of YYB101 with Irinotecan, patients who are metastatic or recurrent Colorectal Cancer Patients. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
YYB101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesSouth Korea
Study dates
9 Aug 2019to 21 Dec 2021
Phase
Phase 1/2
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

  • Male and female patients aged ≥ 19 years
  • Patients with histologically confirmed metastatic or recurrent colorectal cancer
  • Patients who progressed after standard anticancer treatment including existing fluoropyrimidine, oxaliplatin, and irinotecan
  • Patients who received anticancer treatment including irinotecan for at least 6 weeks, with progression confirmed radiologically while on anticancer treatment or within 6 months (24 weeks) after completion of anticancer treatment
  • Adjuvant therapy is acknowledged as an anticancer therapy, if PD is confirmed within 6 months (24 weeks) after the last dose
  • Patients who are unable to undergo radical resection 3) Patients with Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 4) Patients with life expectancy of at least 12 weeks 5) Patients with confirmed adequate hematologic, renal and hepatic function based on the following criteria:
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  • ANC ≥ 1,500/μL (without granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to baseline)
  • Platelet ≥ 100,000/μL (without transfusion within 2 weeks prior to baseline)
  • Hemoglobin ≥ 9 g/dL (without transfusion within 4 weeks prior to baseline)
  • Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (eGFR) (or GFR) ≥ 60 mL/min/1.73 m2
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST and ALT ≤ 5 X ULN for subjects with confirmed hepatic metastases)
  • Total bilirubin ≤ 1.5 X ULN
  • Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN
  • Urine protein to creatinine ratio (UPC) < 1.0 0 (g/g)a a UPC will be conducted only when urine dipstick protein level is ≥ 1 positive (+).
  • 6. Patients with a measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 7. Patients who voluntarily agree to participate in the study and sign the informed consent form

Who cannot join

  • Patients with hematologic malignancy including lymphoma
  • Patients who received chemotherapy, biological therapy, immunotherapy (including immune checkpoint inhibitors), or radiotherapy within 4 weeks prior to baseline for the treatment of metastatic or recurrent colorectal cancer (Participation is not allowed if nitrosoureas or mitomycin is administered within 6 weeks prior to baseline or if biological target antibody is administered within 8 weeks prior to baseline)
  • Patients with a history of primary malignancy other than colorectal cancer. However, the patients are permitted to participate if:
  • They have not received any treatment for the tumor or are disease-free for at least 5 years (For papillary carcinoma of thyroid, participation in the study is allowed even if it has not been more than 5 years after radical resection.)
  • At least 1 year has passed since complete resection of basal/squamous cell carcinoma of the skin or successful treatment of cervical carcinoma in situ
  • Patients with symptomatic central nervous system metastases (except for patients who have discontinued systemic corticosteroid treatment at least 4 weeks prior to baseline and are neurologically stable for at least 4 weeks)
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  • Patients with the following medical or surgical/procedural history
  • Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
  • History of infection with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) within 6 months (24 weeks) prior to baseline
  • History of acute coronary syndrome (unstable angina or myocardial infarction) within 6 months (24 weeks) prior to baseline
  • Serious cerebrovascular disease such as stroke within 6 months (24 weeks) prior to baseline
  • Major surgery that requires general anesthesia or a ventilation assist within 4 weeks prior to baseline (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery)
  • Patients with any of the following diseases:
  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 90 mmHg despite drug treatments)
  • Clinically significant cardiovascular abnormalities as determined by the investigator (e.g., left ventricular ejection fraction [LVEF] < 50%, clinically significant abnormal cardiac wall or myocardial injury, or uncontrolled cardiac arrhythmias)
  • Known positive human immunodeficiency virus (HIV)
  • Severe infection requiring systemic antibiotics, antivirals, etc. or other uncontrolled acute active infectious diseases
  • Chronic inflammatory bowel disease
  • Severe enteroplegia or ileus requiring intervention
  • Pneumonitis or pulmonary fibrosis
  • Large amount of ascites or pleural fluid
  • Diarrhea (watery stool)
  • Patients requiring continued treatment with systemic corticosteroids
  • Patients on antithrombotic agents (patients on low dose aspirin of < 325 mg for inhibition of platelet aggregation is allowed to participate) or with a predisposition to bleeding, large amount of hemoptysis, gastrointestinal hemorrhage or peptic ulcers
  • Patients with a history of severe drug hypersensitivity or hypersensitivity to class of drugs similar to the study drug/concurrent medications
  • Pregnant or breast-feeding women
  • Women of childbearing potential and men who are unwilling to remain abstinent or use appropriate methods of contraception during the study and for at least 5 months (20 weeks) following the end of treatment
  • Patients who received other investigational product or used any investigational device within 4 weeks prior to baseline
  • Patients considered ineligible to participate in the clinical study according to the investigator's judgement for other reasons

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • National Cancer Center

    Seoul, Goyang-si, Gyeonggi-do, 10408

  • Seoul ST. Mary's Hospital

    Seoul, Seocho-gu, 06591

Other trials in South Korea

About this study

Official title: A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab) in Combination With Irinotecan in Metastatic or Recurrent Colorectal Cancer Patients

To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of YYB101 with Irinotecan, patients who are metastatic or recurrent Colorectal Cancer Patients.

Read the detailed description

Metastatic or recurrent colorectal cancer patients will be enrolled to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YYB101 in combination with irinotecan. In Phase 1b, YYB101 20 mg/kg in combination with irinotecan 150 mg/m2 will be administered as a dose level 0, and the safety and pharmacokinetic assessments will be performed based on the DLT after a 4-week treatment period. If no DLT occurs during the 4-week observation period, dosing will be continued every 2 weeks until progressive disease (PD) or unacceptable toxicity occurs. After completion of Phase 1b, the SRC will determine the RP2D of YYB101 and irinotecan, and Phase 2a will be initiated. Stage 2 will proceed when unconfirmed response is observed in one or more subjects out of 10 subjects evaluable for tumor in Phase 2a Stage 1 which includes the RP2D dose cohort in Phase 1b.

Being tested
YYB101

What participants receive

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

  • YYB101Drug

    1. b (Dose level 0 cohort): YYB101 20mg/kg, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity
    2. a Stage 1: YYB101 RP2D, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity
Study groups in NCT04368507
Study groupRoleWhat they receive
YYB101+IrinotecanExperimental1. b (Dose level 0 cohort): YYB101 20mg/kg, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks 2. a Stage 1: YYB101 RP2D, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks
Receives: Drug: YYB101

What is being measured

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

  1. 1b (Dose level 0) cohort: Safety, Tolerability of YYB101 by DLTs and MTD

    DLTs and MTD

    Measured: 28 days

  2. 2a cohort: Safety, Tolerability of YYB101 by ORR

    ORR

    Measured: By 12 months after enrollment of the last subject

Secondary outcomes (13)

  1. 1b (Dose level 0) cohort

    Safety and tolerability (MTD/RP2D based by DLT, Incidence of AEs that result in discontinuation and dose reduction of YYB101, Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101, Vital sign that result in discontinuation and dose reduction of YYB101, Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101)

    Measured: By 12 months after enrollment of the last subject

  2. 1b (Dose level 0) cohort

    Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

    Measured: By 12 months after enrollment of the last subject

  3. 1b (Dose level 0) cohort

    Pharmacokinetics: Peak Plasma Concentration (Cmax)

    Measured: By 12 months after enrollment of the last subject

  4. 1b (Dose level 0) cohort

    Pharmacokinetics: Serum HGF Concentration profile

    Measured: By 12 months after enrollment of the last subject

  5. 1b (Dose level 0) cohort

    Antitumor activity of YYB101 and Irinotecan (Tumor response result evaluted by RECIST version 1.1)

    Measured: By 12 months after enrollment of the last subject

  6. 2a cohort

    Progression-free survival (PFS) will be measured using RECIST version 1.1

    Measured: By 12 months after enrollment of the last subject

  7. 2a cohort

    Disease Control Rate (DCR) will be measured using RECIST version 1.1

    Measured: By 12 months after enrollment of the last subject

  8. 2a cohort

    Duration Of Response (DOR) will be measured using RECIST version 1.1

    Measured: By 12 months after enrollment of the last subject

  9. 2a cohort

    Overall Survival (OS) will be measured using RECIST version 1.1

    Measured: By 12 months after enrollment of the last subject

  10. 2a cohort

    Safety profile (Incidence of AEs that result in discontinuation and dose reduction of YYB101, Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101, Vital sign that result in discontinuation and dose reduction of YYB101, Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101)

    Measured: By 12 months after enrollment of the last subject

  11. 2a cohort

    Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

    Measured: By 12 months after enrollment of the last subject

  12. 2a cohort

    Pharmacokinetics: Peak Plasma Concentration (Cmax)

    Measured: By 12 months after enrollment of the last subject

  13. 2a cohort

    Pharmacokinetics: Serum HGF Concentration profile [only stage 1 subject]

    Measured: By 12 months after enrollment of the last subject

Timeline

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

  1. First posted29 Apr 2020
  2. Study start9 Aug 2019
  3. Primary completion21 Dec 2021
  4. Study completion21 Dec 2021

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368507
Sponsor's protocol ID
NOV110501-201
Status last verified
Nov 2022
First submitted
24 Nov 2019
Last updated
14 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YYB101 in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by CellabMED 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 15 inclusion and 30 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 14 Nov 2022. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

1b (Dose level 0) cohort: Safety, Tolerability of YYB101 by DLTs and MTD (time frame: 28 days). The study lists 2 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 NCT04368507.

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 14 Nov 2022.

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