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Solid TumorPhase 1NCT03552406

Study of ISU104, Targeting ERBB3 in Patients With Advanced Solid Tumors

A Phase 1 study testing ISU104 and Cetuximab in people with Solid Tumor, run by ISU Abxis Co., Ltd. at 5 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase I, open-label, dose-finding study to assess the safety, tolerability and pharmacokinetics of ISU104, a human monoclonal antibody targeting erbB3 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Solid Tumor
What is being tested?
ISU104 and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
5 sitesSouth Korea
Study dates
27 Apr 2018to 31 Dec 2021
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

  • Common
  • Male or Female with ≥ 19 years of age
  • Histologically or Cytologically confirmed a diagnosis of an advanced solid tumor that was refractory to standard treatment or for which no standard therapy existed, or patients declined any treatment options
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Life Expectancy ≥ 12 weeks
  • Adequate Hematological, Renal and Hepatic function
  • According to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1, the patient had at least one measurable lesion

Who cannot join

  • Severe hypersensitivity or a history of any hypersensitivity to the similar drug class of IP
  • Patients underwent the major surgery or procedure, or had the medical history (as blow):
  • Major surgery requiring systemic anesthesia or respiratory assist device within 4 weeks prior to baseline [2 weeks in case of video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery)]
  • Severe cardiovascular disease within 24 weeks prior to baseline
  • Severe cerebrovascular disease within 24 weeks prior to baseline
  • Pulmonary thromboembolism, deep vein thrombosis (DVT) or other clinically and significantly severe lung disease within 24 weeks prior to baseline
Show all 33Show fewer
  • Patients had the following concurrent diseases at baseline:
  • Hematologic malignancies including lymphoma
  • Clinically significant symptom or uncontrolled central nervous system (CNS) or brain metastases
  • Pleural effusion and ascites drainage
  • Uncontrolled hypertension (SBP/DBP > 160/100 mmHg)
  • Active hepatitis B or C virus
  • Human immunodeficiency virus (HIV) that is positive
  • Thromboembolic disease or bleeding diatheses
  • Interstitial lung disease (ILD)
  • Left ventricular ejection fraction (LVEF) value, when measured by echocardiogram, multiple gated acquisition (MUGA) scan or a standard procedure in the institution within 4 weeks prior to the study entry
  • Patients with the following medication history:
  • anti-ErbB3 targeted therapies
  • small-molecule tyrosine kinase inhibitors within 2 weeks prior to baseline
  • any anti-cancer therapy, including chemotherapy, radiotherapy, biologic therapy, retinoid therapy, or therapeutic/palliative radiotherapy for the treatment of advanced solid tumors within 4 weeks prior to baseline
  • Granulocyte-Colony Stimulating Factor (G-CSF), packed red cell or platelet transfusion within 2 weeks prior to the first injection of IP to correct the abnormal values of absolute neutrophil count (ANC) or platelet count
  • Pregnant woman, breastfeeding woman, or women of childbearing age and men with partners of childbearing age, unless they are willing to follow abstinence or use effective forms of contraception* from the study entry until at least 16 weeks after the EOT visit
  • Subjects receiving any other investigational products or medical devices within 4 weeks prior to screening
  • Principal investigator's opinion
  • [Part 1 Dose-escalation cohort]
  • Patients with severe hypersensitivity or history of hypersensitivity to the similar drug class of the investigational product.
  • Patients receiving anti-cancer therapy, including chemotherapy, radiotherapy, biologic therapy, retinoid therapy, or therapeutic/palliative radiotherapy for treatment of advanced solid tumors within four weeks prior to baseline.
  • [Part 2 dose-expansion cohort]
  • Patients with history of allergy or hypersensitivity to the investigational product (ISU104 or cetuximab) or any excipients of the investigational product or its similar derivatives.
  • Patients with primary malignant neoplasm, including head and neck cancer as specified in inclusion criteria of Part 2 dose-expansion cohort. However, an exception may be allowed for the following:
  • For respective malignancy, treatment-naïve or disease-free patients for at least three years (however, patients undergoing radical resection on papillary thyroid carcinoma may be eligible for this clinical trial, even though three years have not passed).
  • Total dissection of skin basal cell carcinoma/squamous cell carcinoma or at least one year had passed since successful treatment of cervical intraepithelial neoplasia.
  • Patients receiving anti-cancer therapy, including chemotherapy, radiotherapy, biologic therapy, retinoid therapy, therapeutic/palliative radiotherapy, or hormone therapy for treatment of advanced solid tumors within four weeks prior to baseline.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Kosin University Gospel Hospital

    Busan

  • Kyungpook National University Chilgok Hospital

    Daegu

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability and Pharmacokinetics of ISU104, a Human Monoclonal Antibody Targeting ErbB3 in Patients With Advanced Solid Tumors

A phase I, open-label, dose-finding study to assess the safety, tolerability and pharmacokinetics of ISU104, a human monoclonal antibody targeting erbB3 in patients with advanced solid tumors.

Read the detailed description

[Part 1 Dose-escalation]

This study ams to evaluate the safety, tolerability, and pharmacokinetics of ISU104 in patients with advanced solid tumors.

Primary objective To determine recommended Phase II dose (RP2D) of ISU104 based on the results of its safety and tolerability in patients with advanced solid tumors.

Secondary objectives

  1. To evaluate pharmacokinetics (PK) of ISU104 in patients with advanced solid tumors.
  2. To evaluate efficacy of ISU104 in patients with advanced solid tumors.

Exploratory purpose To identify the expression of explorable multiple tumor biomarkers and to analyze the relationship between biomarkers and antitumor activity of ISU104.

[Part 2 dose-expansion] The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ISU104 in patients with recurrent/metastatic HNSCC (except for nasopharyngeal cancer), when administered intravenously ISU104 alone or ISU104 in combination with cetuximab.

Primary objective To determine RP2D of ISU104 based on results of its safety and tolerability in patients with recurrent/metastatic HNSCC (except for nasopharyngeal cancer), when administered intravenously ISU104 only or ISU104 in combination with cetuximab.

Secondary objectives

  1. To evaluate the pharmacokinetics of ISU104 in patients with recurrent/metastatic HNSCC (except for nasopharyngeal cancer), when administered intravenously ISU104 only or ISU104 in combination with cetuximab.
  2. To evaluate the efficacy of ISU104 in patients with recurrent/metastatic HNSCC (except for nasopharyngeal cancer), when administered intravenously ISU104 only or ISU104 in combination with cetuximab.

Exploratory purpose To explore a variety of detectable tumor biomarkers and evaluate the relationship between these biomarkers and antitumor activity of ISU104.

Conditions
Solid Tumor
Being tested
ISU104, Cetuximab
Keywords
Solid tumor, Breast cancer, Head & Neck cancer
Medical subject headings
Breast Neoplasms, Head and Neck Neoplasms

What participants receive

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

  • ISU104Biological

    Also called A human monoclonal antibody targeting ErbB3

    Intravenous Infusion for 1 hour.

  • CetuximabDrug

    Also called Erbitux, Epidermal Growth Factor Receptor (EGFR) inhibitor

    Intravenous Infusion for 1 hour (2 hours at initial dose)

Study groups in NCT03552406
Study groupRoleWhat they receive
Dose-Escalation of ISU104 (Dose-Level 1)Experimental1 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Receives: Biological: ISU104
Dose-Escalation of ISU104 (Dose-Level 2)Experimental3 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Receives: Biological: ISU104
Dose-Escalation of ISU104 (Dose-Level 3)Experimental5 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Receives: Biological: ISU104
Dose-Escalation of ISU104 (Dose-Level 4)Experimental10 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Receives: Biological: ISU104
Dose-Escalation of ISU104 (Dose-Level 5)Experimental20 mg/kg; Administered single-dose first week and observation for 4-weeks and then Administered once weekly in a 28-days Cycle
Receives: Biological: ISU104
Dose-Expansion of ISU104 (Group 1: Monotherapy)ExperimentalISU104 20 mg/kg to be administered every three weeks (Q3W) as monotherapy
Receives: Biological: ISU104
Dose-Expansion of ISU104 (Group 2: Combination therapy)ExperimentalISU104 20 mg/kg (or decreased dose) Q3W in combination with cetuximab* 250 mg/m2 QW (*Initial dose: 400 mg/m2)
Receives: Biological: ISU104; Drug: Cetuximab

What is being measured

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

  1. Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities

    Determination of MTD is dependent upon number of cohorts and patients required

    Measured: From date of first dose to 4 weeks after administration.

Secondary outcomes (7)

  1. Toxicity Evaluation

    To determine the occurrence of Adverse Events (AEs)

    Measured: through the study completion, an average of 1 year

  2. Determine Immunogenicity of ISU104

    To measure the level of Anti-Drug Antibody (ADA) and/or Neutralizing Antibody (NAb) of ISU104

    Measured: through the study completion, an average of 1 year

  3. Determine the Peak Plasma Concentration (Cmax) of ISU104

    To measure the Peak Plasma Concentration (Cmax) of ISU104

    Measured: up to 12 weeks

  4. Determine the Area Under the Curve (AUC) of ISU104

    To measure the Area under the plasma concentration versus time curve (AUC) of ISU104

    Measured: up to 12 weeks

  5. Explore Overall Response Rate (ORR) of ISU104 or ISU104+Cetuximab

    To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >30% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline

    Measured: up to progression, an average 6 months

  6. Explore Disease Control Rate (DCR) of ISU104 or ISU104+Cetuximab

    To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >30% decrease in tumor burden from baseline, a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline, and Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Partial Response (defined as >20% decrease in tumor burden from baseline)

    Measured: up to progression, an average 6 months

  7. Explore Progression-Free Survival (PFS) of ISU104 or ISU104+Cetuximab

    To measure the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    Measured: up to progression, an average 6 months

Timeline

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

  1. First posted11 Jun 2018
  2. Study start27 Apr 2018
  3. Primary completion19 Oct 2020
  4. Study completion31 Dec 2021 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
A. Part 1: Dose escalation * Total 15 subjects: 3 subjects in each dose level * 1mg/kg/day, 3mg/kg/day, 5mg/kg/day, 10mg/kg/day, 20mg/kg/day B. Part 2: Dose expansion * Group 1 (Mono-therapy: 20 mg/kg/day, Q3W): 6 subjects * Group 2 (Combination therapy with cetuximab 400 mg/m2 followed by 250 mg/m2, Q1W): 12 subjects
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552406
Sponsor's protocol ID
ISU104-001
Status last verified
May 2021
First submitted
2 May 2018
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seo S, Keam B, Shin SH, Chae YS, Kim TM, Park LC, Hong SB, Ahn MJ, Kim SB. A phase Ia/Ib study of novel anti-ErbB3 monoclonal antibody, barecetamab (ISU104) in refractory solid cancers and monotherapy or in combination with cetuximab in recurrent or metastatic head and neck cancer. Int J Cancer. 2023 Oct 15;153(8):1501-1511. doi: 10.1002/ijc.34622. Epub 2023 Jun 26.

    PubMed 37357950

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ISU104 and Cetuximab in people with Solid Tumor, run by ISU Abxis Co., Ltd. at 5 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 7 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 6 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 5 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?

Results are not available in the source record.

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?

Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities (time frame: From date of first dose to 4 weeks after administration.). 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 NCT03552406, 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 6 May 2021.

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