CancerPhase 1NCT02055066
A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.
A Phase 1 study testing ARGX-111 in people with Cancer, run by argenx at 2 sites in Belgium.
Trial summary
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ARGX-111
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2014to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age ≥ 18 years.
- Performance status of 0 or 1.
- Histological diagnosis of malignancy.
- Cancer relapsing after, or refractory to standard therapy.
- Malignancy over-expressing the c Met protein.
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- Presence of circulating tumor cells (CTCs).
- At least one tumor lesion > 2 cm on PET/CT.
- Serum albumin > 35 g/L.
- Absolute neutrophil count (ANC) > 1.0 x 109/L.
- Hemoglobin > 90 g/L (0.9 g/dL).
- Platelet count ≥ 75 x 109/L.
- Coagulation parameters ≤ 1.5 x ULN.
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
- Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.
- Serum creatinine ≤ 1.5 x ULN.
- Ability to comply with protocol-specified procedures/evaluations and scheduled visits.
Who cannot join
- History or clinical evidence of neoplastic central nervous system (CNS) involvement.
- Major surgery within 4 weeks of ARGX 111 first dose administration.
- Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
- Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
- Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
- Biological therapy (monoclonal antibodies) within 4 weeks of ARGX 111 first dose administration.
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- Biological therapy (other than monoclonal antibodies) within 5 half-lives of ARGX 111 first dose administration.
- Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy.
- History of recurrent Grade 3 or 4 toxicity from anti c Met therapy.
- Uncontrolled diabetes, defined as fasting glycemia > 150 mg/dl).
- Active, untreated viral, bacterial, or systemic fungal infection.
- Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
- Childbearing potential (unless using an adequate measure of contraception).
- Pregnancy or lactation.
- History of severe (Grade 3 or 4) hypersensitivity to recombinant proteins.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universitair Zieckenhuis Antwerpen
Antwerp
Institut Jules Bordet
Brussels
About this study
Official title: A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer Over-expressing the c-Met Protein.
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.
Read the detailed description
This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.
- Conditions
- Cancer
- Being tested
- ARGX-111
- Keywords
- cancer, c-MET
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGX-111Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ARGX-111 0.3 mg/kg Receives: Drug: ARGX-111 |
| Arm 2 | Experimental | ARGX-111 1.0 mg/kg Receives: Drug: ARGX-111 |
| Arm 3 | Experimental | ARGX-111 3.0 mg/kg Receives: Drug: ARGX-111 |
| Arm 4 | Experimental | ARGX-111 10 mg/kg Receives: Drug: ARGX-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Number of patients with grade 3 or 4 toxicity
Measured: 1 month
Secondary outcomes (3)
Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life)
Measurement of drug concentration in the blood
Measured: C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle ≥2 o D1 pre-/post-dose
Biomarkers (Hepatocyte growth factor; ADCC)
measurements of cytokine changes in blood as a result of drug administration
Measured: Base-line and pre-dose at each cycle for an average of 4 months
Incidence of adverse events per dose level
Measured: for an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad Awada, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055066
- Sponsor's protocol ID
- ARGX-111-1301
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2014
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer Over-expressing the c-Met Protein.
- ClinicalTrials.gov ID
- NCT02055066
- Acronym / sponsor ID
- ARGX-111-1301
- Conditions
- Cancer
- Keywords
- cancer, c-MET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.
Detailed description
This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ARGX-111ARGX-111 0.3 mg/kg |
| Arm 2 | Experimental | Drug: ARGX-111ARGX-111 1.0 mg/kg |
| Arm 3 | Experimental | Drug: ARGX-111ARGX-111 3.0 mg/kg |
| Arm 4 | Experimental | Drug: ARGX-111ARGX-111 10 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written informed consent.
- Age ≥ 18 years.
- Performance status of 0 or 1.
- Histological diagnosis of malignancy.
- Cancer relapsing after, or refractory to standard therapy.
Key exclusion criteria (15 listed)
- History or clinical evidence of neoplastic central nervous system (CNS) involvement.
- Major surgery within 4 weeks of ARGX 111 first dose administration.
- Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
- Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
- Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARGX-111 | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Dose-limiting toxicity
Time frame: 1 month
Number of patients with grade 3 or 4 toxicity
3 secondary outcomes
Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life)
Time frame: C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle ≥2 o D1 pre-/post-dose
Biomarkers (Hepatocyte growth factor; ADCC)
Time frame: Base-line and pre-dose at each cycle for an average of 4 months
Incidence of adverse events per dose level
Time frame: for an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Awada, MD principal investigator
Jules Bordet Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARGX-111 in people with Cancer, run by argenx at 2 sites in Belgium.
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 17 inclusion and 15 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.