AzTrials
AzTrials

HER-2 Protein OverexpressionPhase 2BIOs-HerNCT04215159

Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor

A Phase 2 study testing Trastuzumab biosimilar, Gemcitabine Hydrochloride and Irinotecan Hydrochloride in people with HER-2 Protein Overexpression and HER-2 Gene Amplification, run by Jin-Hee Ahn.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland tumors. Read more about this study

Who is it for?
Ages 19 to 79 years
What is being tested?
Trastuzumab biosimilar, Gemcitabine Hydrochloride and Irinotecan Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
30 Dec 2019to 30 Dec 2019
Phase
Phase 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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed HER2 -overexpression (HER2 overexpression defined as 3+ positive by immunohistochemistry, positive by fluorescence in situ hybridization (FISH), or confirmation of HER2 amplification). However hepatic cancer and breast cancer are exclude as HER2 targeted treatment is already a standard treatment for these tumor types.
  • Patients who have progressed after at least one standard treatment or unable to continue standard treatment due to adverse events.
  • Patients confirmed as metastatic or unresectable cancer by imaging test
  • At least one measurable lesion that can be accurately assessed by imaging according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry
  • Adequate organ function (bone marrow, liver, kidney function) A. ANC ≥ 1000/mL B.Platelets ≥ 75,000/uL C.Hemoglobin >8.0 g/dL D.Total bilirubin ≤ 2.0x ULN E.AST and ALT < 5.0 x ULN F.Alkaline phosphatase <2.5x ULN GCreatinine ≤ 2.0x ULN or CCr >30 ml/min
Show all 9Show fewer
  • Estimated life expectancy of more than 3 months
  • Left ventricular ejection fraction of at least ≥ 50% at trial entry
  • Age ≥19 years who have signed an informed consent approved by Institutional Review Board of Organization

Who cannot join

  • Either woman of pregnancy or breast-feeding woman who is positive for hCG
  • Symptomatic or unstable metastases to central nervous system (exceptions : properly treated brain metastasis with no evidence of progression on CT or MRI scan compared with prior examination and without requirement for steroid therapy for relief of symptom. Treatment of an anticonvulsant of stable dose for more than 4 months is permitted taken.
  • Evidence of viral, bacterial, or fungal infection including active hepatitis C and D or HIV infection.
  • Underwent major surgery of have not fully recovered from certain procedures within 4 months prior to taking the investigational product
  • History of malignant disease within 3 years prior to taking the investigational product (exceptions: treated carcinoma in situ of cervix, differentiated thyroid cancer without lymph node metastasis, and skin cancer other than melanoma).
  • Interval of QTc > 480 msec (in terms of average measurement of EKG 3 times), oneself or family known to be long or short QT, brugada syndrome or other known QTc prolongation history or Torsade de Pointes.
Show all 11Show fewer
  • Following symptoms or disease within 6 months prior to taking the investigational product: myocardiac infarction, NCI CTCAE v 5.0 Grade ≤2 severe/unstable angina, continuous arrhythmia, atrial fibrillation, bypass surgery of coronary or peripheral arteries, symptomatic heart failure, cerebrovascular events including transient ischemic attack, or symptomatic pulmonary embolism.
  • History of symptomatic interstitial lung disease
  • Hypersensitivity reaction to Trastuzumab, Gemcitabine, Irinotecan or components of these agents
  • Patients with diarrhea, intestinal paralysis, intestinal obstruction, massive ascites, or pleural effusion
  • Other psychiatric problems, suicidal attempt, abnormal test results that can affect the administration of the investigational product or participation of clinical trial or that can impact the results of the clinical trial, and any other reason that investigator acknowledge as unsuitable factor for participating the clinical trial.

About this study

Official title: Prospective Phase II Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Solid Tumor

HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used after gaining official permission recently, clinical data for this use is still lacking, especially regarding experiences of combination with various cytotoxic chemotherapy agents.

Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in patient's blood originated from a tumor is being developed and improved along with introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic testing.

The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to investigate the association between ctDNA and clinical outcomes such as disease response, progression-free survival, and overall survival.

Read the detailed description

Samfenet is a biosimilar of trastuzumab and received marketing approval based on the results of efficacy equivalence to trastuzumab. This study is a phase 2 study to investigate the efficacy of Samfenet in combination with cytotoxic agents in patients with HER2-positive solid tumors.

A total of 42 patients will be enrolled. Treatment will be continues until disease progression, unacceptable toxicity or patient withdrawal. Tumor evaluation will be performed at every 8 weeks during treatment, and then at every 12 weeks thereafter end of study.

Being tested
Trastuzumab biosimilar, Gemcitabine Hydrochloride, Irinotecan Hydrochloride
Keywords
HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 targeted-treatment, Trastuzumab biosimilar, samfenet

What participants receive

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

  • Trastuzumab biosimilarDrug

    Also called Samfenet

    1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks.

  • Gemcitabine HydrochlorideDrug

    Also called Gemtan

    1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks.

  • Irinotecan HydrochlorideDrug

    Also called Calmtop

    100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.

Study groups in NCT04215159
Study groupRoleWhat they receive
Samfenet and Treatment of physician's choiceExperimental* Samfenet : 1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks. * Treatment of physician's choice (Gemcitabine or Irinotecan) 1. Gemcitabine : 1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks. 2. Irinotecan : 100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.
Receives: Drug: Trastuzumab biosimilar; Drug: Gemcitabine Hydrochloride; Drug: Irinotecan Hydrochloride

What is being measured

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

  1. objective response rate

    Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 8 weeks

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the first dose of trial treatment to the date of disease progression or death due to any cause, whichever occurs first.

    Measured: 3 years

  2. overall survival (OS)

    OS is defined as the time from the first dose of trial treatment to the death of all causes or the last follow-up.

    Measured: 3 years

  3. Safety profile: NCI-CTCAE

    Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03

    Measured: 3 years

Timeline

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

  1. First posted2 Jan 2020
  2. Study start30 Dec 2019 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04215159
Sponsor's protocol ID
2019-0989
Acronym
BIOs-Her
Status last verified
Dec 2019
First submitted
24 Sep 2019
Last updated
2 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab biosimilar, Gemcitabine Hydrochloride and Irinotecan Hydrochloride in people with HER-2 Protein Overexpression and HER-2 Gene Amplification, run by Jin-Hee Ahn.

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 9 inclusion and 11 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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?

objective response rate (time frame: 8 weeks). 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 NCT04215159.

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 2 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in