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Advanced Solid TumorPhase 1/2NCT04441099

NBE-002 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing NBE-002 in people with Advanced Solid Tumor and Advanced Cancer, run by NBE-Therapeutics AG at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NBE-002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesUnited States
Study dates
19 Jun 2020to 14 Aug 2023
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

  • Written informed consent
  • Age ≥18 years
  • Phase 1, DEC and SEC: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma), who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available
  • Phase 2, EC1: patients with histologically or cytologically confirmed advanced triple-negative breast cancer, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
  • Phase 2, EC2: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma) other than TNBC, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
  • Availability of pretreatment tumor tissue
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  • Phase 1, DEC and SEC: at least one measurable or non-measurable lesion as per RECIST v1.1
  • Phase 2, EC1 and EC2: at least one measurable lesion as per RECIST v1.1
  • Phase 1, DEC and SEC: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Phase 2, EC1 and EC2: ECOG performance status of 0 or 1
  • Adequate function of bone marrow, liver, kidneys, heart; adequate coagulation profile
  • Both male and female patients must agree to use effective contraceptive methods
  • Women of child-bearing potential (WCBP) must have a negative serum pregnancy test
  • Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements

Who cannot join

  • Prior treatment with any agent targeting ROR1
  • Presence of active central nervous system (CNS) metastasis
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade > 1 (or Grade > 2 for neurotoxicity)
  • Systemic anti-neoplastic therapy within five half-lives or four weeks (six weeks for nitrosourea and mitomycin-C), whichever is shorter, prior to first dose of the study drug
  • Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
  • Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
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  • Prior allogeneic bone marrow transplantation
  • Significant cardiac disease
  • History of thromboembolic or cerebrovascular events within six months prior to first dose of the study drug
  • Acute and/or clinically significant bacterial, fungal or viral infection
  • Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day
  • Concurrent participation in another investigational clinical trial
  • Pregnant or breast-feeding females
  • Other conditions that prevent the patient from giving informed consent or participating in the trial, or that may increase the risk associated with the study participation, or that may interfere with the interpretation of the study results
  • Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study drug
  • Prior treatment with cumulative lifetime dose of anthracycline

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute - TN Oncology

    Nashville, Tennessee, 37203

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors.

Being tested
NBE-002
Keywords
ROR1, Antibody-drug Conjugate, Carcinoma, Cancer, Solid Tumor, Sarcoma, Triple Negative Breast Cancer
Medical subject headings
Triple Negative Breast Neoplasms, Carcinoma, Neoplasms, Sarcoma

What participants receive

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

  • NBE-002Drug

    NBE-002 will be given intravenously on Day 1 of repeated 28-day cycles.

Study groups in NCT04441099
Study groupRoleWhat they receive
Dose-escalation Cohort (DEC)ExperimentalEscalating doses of NBE-002 depending on cohort at enrollment.
Receives: Drug: NBE-002
Safety-expansion Cohort (SEC)ExperimentalDose to be determined based on DEC.
Receives: Drug: NBE-002
Expansion Cohort 1 (EC1)ExperimentalDose to be determined based on DEC and SEC.
Receives: Drug: NBE-002
Expansion Cohort 2 (EC2)ExperimentalDose to be determined based on DEC and SEC.
Receives: Drug: NBE-002

What is being measured

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

  1. Recommended Phase 2 Dose (RP2D) (Phase 1)

    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    Measured: Up to 48 months

  2. Anti-tumor Activity (Phase 2)

    Anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

    Measured: Up to 60 months

Secondary outcomes (4)

  1. Incidence of Adverse Events (Safety and Tolerability)

    Safety and tolerability profile will be assessed by Common Terminology Criteria for Adverse Events v5.0 and summarized by type, frequency, and severity of adverse events

    Measured: Up to 60 months

  2. Preliminary Anti-tumor Activity (Phase 1)

    Preliminary anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

    Measured: Up to 48 months

  3. Concentrations of NBE-002

    Pharmacokinetic profile will be characterized by concentrations of NBE-002

    Measured: Up to 60 months

  4. Concentrations of NBE-002-reactive antibodies

    Immunogenicity profile will be characterized by concentrations of NBE-002-reactive antibodies

    Measured: Up to 60 months

Timeline

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

  1. First posted22 Jun 2020
  2. Study start19 Jun 2020
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: End of Program

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04441099
Sponsor's protocol ID
NBE-002-01
Status last verified
Jul 2023
First submitted
18 Jun 2020
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NBE-002 in people with Advanced Solid Tumor and Advanced Cancer, run by NBE-Therapeutics AG at 3 sites in United States.

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 16 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: stopped early, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 was stopped early (reason given: End of Program). 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?

Recommended Phase 2 Dose (RP2D) (Phase 1) (time frame: Up to 48 months). The study lists 2 primary outcomes in all. 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 NCT04441099.

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 7 Sep 2023.

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