NBE-002 for Cancer

No longer recruiting at 2 trial locations

Overseen By Manager Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NBE-Therapeutics AG

Must not be taking: Systemic steroids

Disqualifiers: CNS metastasis, Cardiac disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

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

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?

Group I: Safety-expansion Cohort (SEC) Experimental Treatment 1 Intervention

Dose to be determined based on DEC.

Group II: Expansion Cohort 2 (EC2) Experimental Treatment 1 Intervention

Dose to be determined based on DEC and SEC.

Group III: Expansion Cohort 1 (EC1) Experimental Treatment 1 Intervention

Dose to be determined based on DEC and SEC.

Group IV: Dose-escalation Cohort (DEC) Experimental Treatment 1 Intervention

Escalating doses of NBE-002 depending on cohort at enrollment.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience. Chen, KA., Farrar, M., Cardamone, M., et al.[2020]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12034953/

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.

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.TPS1108

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.gov

pubmed.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, ...

4.

aacrjournals.org

aacrjournals.org/cancerres/article/79/13_Supplement/LB-197/638083/Abstract-LB-197-NBE-002-an-anthracycline-based

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 ...

5.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/17588359251332471

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 ...

6.

withpower.com

withpower.com/trial/phase-2-triple-negative-breast-neoplasms-5-2020-3efe7

NBE-002 in Patients With Advanced Solid Tumors

What safety data exists for the treatment NBE-002, also known as cannabidiol (CBD)?. CBD has been associated with some adverse effects, including liver ...

7.

biochempeg.com

biochempeg.com/article/364.html

ROR1 ADCs in Clinical Trials: MK-2140, NBE-002 & CS5001

Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells.

8.

mycancergenome.org

mycancergenome.org/content/clinical_trials/NCT04441099/

Clinical Trial: NCT04441099

This first-in-human study will evaluate the recommended dose for further clinical development, safety ... NBE-002. Safety-expansion Cohort (SEC) ...