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Solid TumorsPhase 1NCT02499224

Safety and Pharmacokinetics Study of YYB101 in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy

A Phase 1 study testing YYB101 in people with Solid Tumors, run by CellabMED at 1 site 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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid tumors patients who are refractory to standard therapy. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Solid Tumors
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
39 participants
Where
1 siteSouth Korea
Study dates
13 Jul 2015to 4 Jul 2018
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

  • Male or female patients aged 19 years or older
  • Patients with pathologically or cytologically confirmed advanced solid tumor which is refractory to standard treatment or for which there is no standard therapy
  • ECOG performance status ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Adequate hematologic, hepatic and renal functions as follows:
  • ANC ≥ 1,500/µL (without G-CSF support within 2 weeks before IP administration)
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  • Platelet ≥ 100,000/µL (without transfusion within 2 weeks before IP administration)
  • Hemoglobin ≥ 10.0 g/dL (without transfusion within 4 weeks before IP administration)
  • Serum creatinine ≤ 1.5 mg/dL or eGRF ≥ 60 mL/min/1.73 m2
  • AST and ALT ≤ 2.5 x ULN (AST and ALT ≤ 5 x ULN in the presence of liver metastasis or hepatocarcinoma)
  • Total bilirubin ≤ 1.5 x ULN (with exception of the case associated with Gilbert's syndrome)
  • PT and aPTT ≤ 1.5 x ULN
  • UPC < 1.0 (g/g) (requiring if protein ≥ 1 positive (+) in urinalysis)
  • Patients who voluntarily give written informed consent

Who cannot join

  • Patients with hematologic malignancies including lymphoma
  • Chemo-, radio-chemo-, biologic-, immuno- or radiotherapy for advanced solid tumor within 4 weeks (or nitrosoureas, mitomycin within 6 weeks or targeted biological antibody within 8 weeks) before IP administration
  • Patients had received high-dose chemotherapy requiring hematopoietic progenitor cell support within 2 years before IP administration
  • Patients with symptomatic central nervous system (CNS) metastasis (patients who are radiologically and neurologically stable condition for ≥ 4 weeks and discontinued corticosteroids at least 4 week before IP administration are able to participate in this trial.)
  • History of deep vein thrombosis or pulmonary embolism within 1 year; Cytomegalovirus (CMV), Epstein-Barr virus (EBV), acute coronary syndrome (including unstable angina or myocardial infarction), or clinically significant cerebrovascular disease (including stroke) within 6 month; Major surgery requiring general anesthesia or respiratory assist within 4 weeks (or video-assisted thoracoscopic surgery or open-and-closed surgery within 2 weeks) before IP administration
  • Concurrent NYHA class III or IV heart failure, uncontrolled hypertension, poorly controlled arrhythmia, other clinically significant cardiovascular abnormalities at investigator's discretion (e.g. LVEF < 50%, clinical significant abnormalities of heart wall, or cardiac muscle damage), known positive result for HIV or other uncontrolled active infection disease
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  • Requirement for continuous non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids
  • Receiving anticoagulant, history of bleeding diathesis, massive hemoptysis, gastrointestinal hemorrhage, or peptic ulcer disease (< 325 mg aspirin is acceptable)
  • History of severe drug hypersensitivity or hypersensitivity to IP or similar Mab
  • Pregnancy or breast-feeding
  • Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
  • Patients who received investigational product or investigational device in other clinical trials within 3weeks prior to participation in this trial
  • Patients who cannot participate in this trial at the investigator's discretion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab), in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid tumors patients who are refractory to standard therapy.

Read the detailed description

To evaluate the safety, tolerability, and pharmacokinetics of YYB101, patients who are refractory to standard therapy will be enrolled in this study. In dose-escalation cohort, subjects will be enrolled sequentially into four dose cohorts receiving a single dose of YYB101 (0.3, 1, 3, or 5 mg/kg; 3 or 6 subjects per dose cohort) and will be entered the 4-week treatment-free period to evaluate safety and pharmacokinetics. If no dose-limiting toxicity (DLT) is observed during the 4-week period, YYB101 administration will be resumed at the same dose level every 2 weeks until disease progression or unacceptable toxicity development. After the completion of the dose-escalation cohort, additional subjects will be enrolled into a dose-expansion cohort at the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for further exploration of safety, tolerability, efficacy and pharmacodynamics.

Conditions
Solid Tumors
Being tested
YYB101

What participants receive

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

  • YYB101Drug

    Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks until disease progression or unacceptable toxicity development.

    Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks until disease progression or unacceptable toxicity development

Study groups in NCT02499224
Study groupRoleWhat they receive
YYB101ExperimentalDose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks
Receives: Drug: YYB101

What is being measured

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

  1. Dose-escalation cohort: DLTs and MTD

    Measured: 28 days

Secondary outcomes (6)

  1. Incidence of AEs that result in discontinuation and dose reduction of YYB101

    Measured: By 12 months after enrollment of the last subject

  2. Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101

    Measured: By 12 months after enrollment of the last subject

  3. Vital sign that result in discontinuation and dose reduction of YYB101

    Measured: By 12 months after enrollment of the last subject

  4. Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101

    Measured: By 12 months after enrollment of the last subject

  5. Area under the plasma concentration versus time curve (AUC) of YYB101

    Measured: By 4 and 8 weeks after last administration, average 16 weeks

  6. Peak Plasma Concentration (Cmax) of YYB101

    Measured: By 4 and 8 weeks after last administration, average 16 weeks

Timeline

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

  1. First posted16 Jul 2015 (estimated)
  2. Study start13 Jul 2015
  3. Primary completion4 Jul 2018
  4. Study completion4 Jul 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499224
Sponsor's protocol ID
NOV110501-101
Status last verified
Mar 2016
First submitted
14 May 2015
Last updated
13 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim ST, Hong JY, Park SH, Park JO, Park YW, Park N, Lee H, Hong SH, Lee SJ, Song SW, Kim K, Park YS, Lim HY, Kang WK, Nam DH, Lee JW, Park K, Kim KM, Lee J. First-in-human phase I trial of anti-hepatocyte growth factor antibody (YYB101) in refractory solid tumor patients. Ther Adv Med Oncol. 2020 Jun 2;12:1758835920926796. doi: 10.1177/1758835920926796. eCollection 2020.

    PubMed 32536979

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YYB101 in people with Solid Tumors, run by CellabMED at 1 site 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 14 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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-escalation cohort: DLTs and MTD (time frame: 28 days). 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 NCT02499224, which also lists 1 linked publication.

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 13 May 2021.

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