NBE-002 in Patients With Advanced Solid Tumors
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: NBE-Therapeutics AG
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing NBE-002, a new treatment that combines an antibody with a drug, in patients with advanced solid tumors. It works by targeting a specific protein on cancer cells to deliver the drug directly and kill the cancer cells.
Eligibility Criteria
Inclusion Criteria
Availability of pretreatment tumor tissue
Phase 2, EC1 and EC2: ECOG performance status of 0 or 1
Phase 1, DEC and SEC: at least one measurable or non-measurable lesion as per RECIST v1.1
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Exclusion Criteria
Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day
Concurrent participation in another investigational clinical trial
Acute and/or clinically significant bacterial, fungal or viral infection
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Treatment Details
Interventions
- NBE-002 (Monoclonal Antibodies)
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Safety-expansion Cohort (SEC)Experimental Treatment1 Intervention
Dose to be determined based on DEC.
Group II: Expansion Cohort 2 (EC2)Experimental Treatment1 Intervention
Dose to be determined based on DEC and SEC.
Group III: Expansion Cohort 1 (EC1)Experimental Treatment1 Intervention
Dose to be determined based on DEC and SEC.
Group IV: Dose-escalation Cohort (DEC)Experimental Treatment1 Intervention
Escalating doses of NBE-002 depending on cohort at enrollment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sarah Cannon Research Institute - TN OncologyNashville, TN
NEXT OncologySan Antonio, TX
The University of Texas MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
NBE-Therapeutics AGLead Sponsor
Cmed Clinical ServicesCollaborator