Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04441099
Previous Study | Return to List | Next Study

NBE-002 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441099
Recruitment Status : Active, not recruiting
First Posted : June 22, 2020
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
Cmed Clinical Services
Information provided by (Responsible Party):
NBE-Therapeutics AG

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Advanced Cancer Triple Negative Breast Cancer Drug: NBE-002 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose-escalation Cohort (DEC)
Escalating doses of NBE-002 depending on cohort at enrollment.
Drug: NBE-002
NBE-002 will be given intravenously on Day 1 of repeated 21-day cycles.

Experimental: Safety-expansion Cohort (SEC)
Dose to be determined based on DEC.
Drug: NBE-002
NBE-002 will be given intravenously on Day 1 of repeated 21-day cycles.

Experimental: Expansion Cohort 1 (EC1)
Dose to be determined based on DEC and SEC.
Drug: NBE-002
NBE-002 will be given intravenously on Day 1 of repeated 21-day cycles.

Experimental: Expansion Cohort 2 (EC2)
Dose to be determined based on DEC and SEC.
Drug: NBE-002
NBE-002 will be given intravenously on Day 1 of repeated 21-day cycles.




Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) (Phase 1) [ Time Frame: Up to 15 months ]
    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

  2. Anti-tumor Activity (Phase 2) [ Time Frame: Up to 18 months ]
    Anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1


Secondary Outcome Measures :
  1. Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: Up to 36 months ]
    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

  2. Preliminary Anti-tumor Activity (Phase 1) [ Time Frame: Up to 15 months ]
    Preliminary anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  3. Concentrations of NBE-002 [ Time Frame: Up to 36 months ]
    Pharmacokinetic profile will be characterized by concentrations of NBE-002

  4. Concentrations of NBE-002-reactive antibodies [ Time Frame: Up to 36 months ]
    Immunogenicity profile will be characterized by concentrations of NBE-002-reactive antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441099


Locations
Layout table for location information
United States, Tennessee
Sarah Cannon Research Institute - TN Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
NBE-Therapeutics AG
Cmed Clinical Services
Layout table for additonal information
Responsible Party: NBE-Therapeutics AG
ClinicalTrials.gov Identifier: NCT04441099    
Other Study ID Numbers: NBE-002-01
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NBE-Therapeutics AG:
ROR1
Antibody-drug Conjugate
Carcinoma
Cancer
Solid Tumor
Sarcoma
Triple Negative Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases