NBE-002 in Patients With Advanced Solid Tumors

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

12 Participants Needed

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.

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.

What safety data exists for the treatment NBE-002, also known as cannabidiol (CBD)?

CBD has been associated with some adverse effects, including liver issues, decreased appetite, diarrhea, and sleepiness. It is generally well tolerated, but interactions with other medications should be monitored carefully, especially in children with epilepsy. ^{1 2 3 4 5}

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

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

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

Treatment Details

Interventions

• NBE-002

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treating Lennox-Gastaut Syndrome and Dravet Syndrome in Korea. [2021]