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NeoplasmsPhase 1/2NCT01813539

A Study of ARGX-110 in Participants With Advanced Malignancies

A Phase 1/2 study testing ARGX-110 in people with Neoplasms, run by OncoVerity, Inc. at 8 sites in 2 countries.

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 determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
ARGX-110
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
8 sitesin 2 countries
Study dates
27 Feb 2013to 10 Jul 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological diagnosis of malignancy refractory to, or relapsing after standard therapy
  • Solid tumors or T-cell malignancies positive for the CD70 antigen by Immunohistochemistry/Fluorescence-activated cell sorting (IHC/FACS) within 56 days prior to administering the first dose of ARGX-110. IHC criterion: greater than > 10 percent (%) of CD70 positive tumor cells
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or 2
  • Serum albumin greater than or equal to (>=) 20 gram per liter (g/L) (solid tumor only)
  • Ability to comply with protocol-specified procedures/evaluations and scheduled visits. In particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4)

Who cannot join

  • History or clinical evidence of neoplastic central nervous system (CNS) involvement
  • History of another primary malignancy that has not been in remission for at least 1 year
  • Systemic glucocorticoid administration at doses greater than physiological replacement (prednisolone 20 milligram [mg] equivalent) within 28 days of ARGX-110 first dose administration (for T-cell malignancies higher systemic dose can be allowed following discussion with Sponsor)
  • Major surgery within 28 days of ARGX-110 first dose administration
  • Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France5 sites

  • Study site

    Bordeaux

  • Study site

    Lille

  • Study site

    Paris

  • Study site

    Pierre-Bénite

  • Study site

    Villejuif

Other trials in France

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Ghent

Other trials in Belgium

About this study

Official title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.

The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).

Read the detailed description

Phase I study conducted in participants whose tumors express the target of interest. Pharmacokinetics (PK), pharmacodynamics (PD), biomarkers will be determined to support dose selection.

Phase II study conducted in Cutaneous T-cell lymphoma (CTCL) participants who are CD70 positive. PK, PD, biomarkers and immunohistochemistry (IHC) will be determined to assess efficacy.

Conditions
Neoplasms
Being tested
ARGX-110
Keywords
Malignancy
Medical subject headings
Neoplasms

What participants receive

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

  • ARGX-110Drug

    ARGX-110 will be administered as an IV infusion.

Study groups in NCT01813539
Study groupRoleWhat they receive
Dose Escalation: Cohort 1ExperimentalParticipants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
Receives: Drug: ARGX-110
Dose Escalation: Cohort 2ExperimentalParticipants will receive ARGX-110 as an IV infusion at dose level 2.
Receives: Drug: ARGX-110
Dose Escalation: Cohort 3ExperimentalParticipants will receive ARGX-110 as an IV infusion at dose level 3.
Receives: Drug: ARGX-110
Dose Escalation: Cohort 4ExperimentalParticipants will receive ARGX-110 as an IV infusion at dose level 4.
Receives: Drug: ARGX-110
Dose Escalation: Cohort 5ExperimentalParticipants will receive ARGX-110 as an IV infusion at intermediate dose level at the conclusion of Cohort 4 prior to opening the safety expansion cohorts to participants enrolment.
Receives: Drug: ARGX-110
Safety Expansion: Cohort 1ExperimentalParticipants with solid tumors will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
Receives: Drug: ARGX-110
Safety Expansion: Cohort 2ExperimentalParticipants with hematological malignancies (all etiologies) will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
Receives: Drug: ARGX-110
Safety Expansion: Cohort 3ExperimentalParticipants with cutaneous T-cell lymphoma (CTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
Receives: Drug: ARGX-110
Safety Expansion: Cohort 4ExperimentalParticipants with peripheral T-cell lymphoma (PTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
Receives: Drug: ARGX-110
Exploratory Efficacy: Cohort 5ExperimentalParticipants with relapsed/refractory CTCL will receive ARGX-110 as an IV infusion followed by a maintenance therapy at dose level 3.
Receives: Drug: ARGX-110

What is being measured

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

  1. Number of Participants with Dose Limiting Toxicity (DLT)

    DLT is defined as drug-related grade 3 or 4 clinical adverse event (AE) occurring during the 21 days (3 weeks) following the first dose of ARGX-110.

    Measured: 21 days

Secondary outcomes (3)

  1. Plasma Concentrations of ARGX-110

    Plasma concentration of ARGX-110 will be assessed.

    Measured: Up to 2 years

  2. Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity

    Biomarkers (CD70 quantitative polymerase chain reaction [CD70 qPCR] and soluble CD27 [sCD27]) will be measured in serum and on tumor samples to correlate systemic drug effects with AE and Tumor response.

    Measured: Up to 2 years

  3. Number of Participants who Achieve a Tumor Response

    Tumor response will be assessed according to RECIST.

    Measured: Up to 2 years

Timeline

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

  1. First posted19 Mar 2013 (estimated)
  2. Study start27 Feb 2013
  3. Primary completion10 Jul 2020
  4. Study completion10 Jul 2020

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01813539
Sponsor's protocol ID
CR108755
Other IDs
ARGX-110-1201, 2012-005046-38
Status last verified
Aug 2023
First submitted
7 Mar 2013
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Silence K, Dreier T, Moshir M, Ulrichts P, Gabriels SM, Saunders M, Wajant H, Brouckaert P, Huyghe L, Van Hauwermeiren T, Thibault A, De Haard HJ. ARGX-110, a highly potent antibody targeting CD70, eliminates tumors via both enhanced ADCC and immune checkpoint blockade. MAbs. 2014 Mar-Apr;6(2):523-32. doi: 10.4161/mabs.27398. Epub 2013 Dec 6.

    PubMed 24492296

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARGX-110 in people with Neoplasms, run by OncoVerity, Inc. at 8 sites in 2 countries.

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 5 inclusion and 5 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, 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 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?

Number of Participants with Dose Limiting Toxicity (DLT) (time frame: 21 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 NCT01813539, 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 9 Aug 2023.

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