NBE-002 for Cancer

No longer recruiting at 2 trial locations
MC
Overseen ByManager Clinical Operations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new treatment called NBE-002 to determine its safety and effectiveness for people with advanced solid tumors, including certain types of breast cancer. The study aims to identify the optimal dose for future treatments. Participants will receive varying doses of the drug to assess its impact on their condition. It suits those with advanced solid tumors who have not responded to other treatments and have a tumor that doctors can measure. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use systemic steroids above a certain dose or have had recent systemic anti-cancer treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that NBE-002 is likely to be safe for humans?

Research has shown that NBE-002 is a new treatment being tested for safety and patient tolerance in those with advanced solid tumors. Early studies have examined how NBE-002 targets and kills cancer cells while sparing healthy ones.

Information on safety is still being gathered. As this trial is in its early stages (Phase 1/2), the primary goal is to assess patient tolerance. Researchers are carefully monitoring for any side effects or adverse reactions. So far, previous patients have tolerated NBE-002, but more data is needed to fully understand its safety.

The trial includes different groups receiving various doses to identify the optimal dose with the fewest side effects. If the treatment proves safe in these early stages, it could lead to more extensive testing later. Findings at this stage are crucial to ensuring the treatment's safety before proceeding further.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about NBE-002 because it offers a novel approach to treating advanced solid tumors. Unlike traditional therapies such as chemotherapy and radiation, which affect both cancerous and healthy cells, NBE-002 is designed to specifically target cancer cells. This targeted approach potentially reduces side effects and increases effectiveness. Additionally, NBE-002 employs an innovative mechanism that could work against tumors that are resistant to current treatments, providing new hope for patients with advanced stages of cancer.

What evidence suggests that NBE-002 could be an effective treatment for advanced solid tumors?

Research has shown that NBE-002, a treatment combining an antibody with a drug, holds promise for treating advanced solid tumors. Studies have found that it can slow tumor growth across various cancer types. In this trial, participants will receive NBE-002, which may be effective alone or in combination with common cancer treatments like carboplatin and paclitaxel. This treatment targets a protein called ROR1, often found in high levels in many cancers, suggesting it could be highly effective for tumors with this protein. Early results support its potential as a promising option for patients with advanced solid tumors.12678

Are You a Good Fit for This Trial?

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
See 10 more

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
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of NBE-002 to determine the recommended Phase 2 dose

48 months

Safety-expansion

Participants receive NBE-002 at doses determined from the dose-escalation phase to assess safety and tolerability

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • NBE-002
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Safety-expansion Cohort (SEC)Experimental Treatment1 Intervention
Group II: Expansion Cohort 2 (EC2)Experimental Treatment1 Intervention
Group III: Expansion Cohort 1 (EC1)Experimental Treatment1 Intervention
Group IV: Dose-escalation Cohort (DEC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NBE-Therapeutics AG

Lead Sponsor

Trials
1
Recruited
10+

Cmed Clinical Services

Collaborator

Trials
3
Recruited
180+

Published Research Related to This Trial

Cannabidiol (CBD) has been associated with significant adverse events, particularly 'weight decreased', 'hypophagia', and 'insomnia', based on a disproportionality analysis of reports from the VigiBase® database involving various patients.
The interaction of CBD with the serotonin 5-HT1A receptor may explain the occurrence of insomnia, highlighting the need for careful monitoring of these side effects in patients using CBD for conditions like Lennox-Gastaut syndrome and Dravet syndrome.
Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase.Calapai, F., Mannucci, C., McQuain, L., et al.[2023]
Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.
The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.
Pharmacovigilance of unlicensed cannabidiol in European countries.Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]
In a study involving 40 children with drug-resistant epilepsy, cannabidiol was found to have a manageable safety profile, with the most common side effect being somnolence, which resolved in most cases.
Caregivers reported subjective improvements in their children's overall health, although the study's open-label design means that it's unclear if these benefits were directly due to cannabidiol treatment.
Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience.Chen, KA., Farrar, M., Cardamone, M., et al.[2020]

Citations

The antibody–drug conjugate targeting ROR1, NBE-002, is ...This study explored the anti-cancer effects of NBE-002 alone and in combination with standard HGSOC therapies, carboplatin, paclitaxel and olaparib.
NBE-002: A novel anthracycline-based antibody-drug ...Direct anti-tumor activity of NBE-002 was evaluated in immunodeficient, ROR1 expression-low/-intermediate/-high PDX models of several carcinoma ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40297621/
The antibody-drug conjugate targeting ROR1, NBE-002, is ...Objectives: This study explored the anti-cancer effects of NBE-002 alone and in combination with standard HGSOC therapies, carboplatin, ...
Abstract LB-197: NBE-002, an anthracycline-based immune ...Conclusion: Our results demonstrate that NBE-002 is a highly effective and promising targeted therapeutic for the treatment of ROR1 positive ...
The antibody–drug conjugate targeting ROR1, NBE-002, is ...NBE-002, an antibody-drug conjugate targeting ROR1, shows therapeutic potential in HGSOC, with single agent activity and broader activity when combined with ...
NBE-002 in Patients With Advanced Solid TumorsWhat safety data exists for the treatment NBE-002, also known as cannabidiol (CBD)?. CBD has been associated with some adverse effects, including liver ...
ROR1 ADCs in Clinical Trials: MK-2140, NBE-002 & CS5001Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells.
Clinical Trial: NCT04441099This first-in-human study will evaluate the recommended dose for further clinical development, safety ... NBE-002. Safety-expansion Cohort (SEC) ...
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