ANTI-(INSULIN RECEPTOR) HUMAN MONOCLONAL ANTIBODY for Tumor-associated hyperinsulinism|Insulinoma

Inclusion criteria

• {"criterion_text":"- The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist to ensure the participant is appropriate for this clinical trial."}
• {"criterion_text":"- Male or female participants of ≥18 years of age who provide written informed consent as per regulations."}
• {"criterion_text":"- Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessments who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement."}
• {"criterion_text":"- Currently requiring IV glucose infusion and/or parenteral nutrition for a specified number of days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug)."}
• {"criterion_text":"- Female participants of childbearing potential must not be pregnant or breast feeding, and willing to use effective contraceptive measures to prevent pregnancy for the duration of the study AND including for up to 5 months after receiving the last dose of study drug."}
• {"criterion_text":"- Male participants with female partner of childbearing potential must be willing to use effective contraceptive measures to prevent pregnancy for the duration of the study AND including for up to 5 months after receiving the last dose of study drug."}

Exclusion criteria

• {"criterion_text":"- Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns)."}
• {"criterion_text":"- Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed."}
• {"criterion_text":"- Any out-of-range laboratory value at screening (other than blood glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed."}
• {"criterion_text":"- Known allergy or sensitivity to ersodetug or any component of the drug."}
• {"criterion_text":"- Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor’s Medical Monitor would pose an unacceptable risk to the participant in the study."}
• {"criterion_text":"- Estimated life expectancy (additional lifespan) due to underlying disease (tumor) as specified in the protocol."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants with clinically meaningful reduction in glucose infusion rate from baseline.","definition_or_measurement_approach":"Proportion measured by change in glucose infusion rate (GIR) from baseline; glycemic efficacy assessed using IV glucose infusion requirements and continuous glucose assessments (CGM/SMBG) as described in objectives and main endpoint definitions."}
• {"endpoint_text":"- OLE: Long-term glycemic efficacy (by SMBG) of ersodetug will be assessed similar to secondary endpoints of the Pivotal Treatment Period (PTP) including SOC antihypoglycemic therapies, HRQoL","definition_or_measurement_approach":"Assessed by SMBG (self-monitored blood glucose) similar to PTP secondary endpoints, including consideration of SOC antihypoglycemic therapies and health-related quality of life measures."}
• {"endpoint_text":"- OLE: Long-term safety and tolerability based on assessments of TEAEs, SAEs, Adverse Events of Special Interest (AESIs), clinical laboratory measurements, immunogenicity assessments, ECG, hepatic ultrasound, vital signs, and physical examination","definition_or_measurement_approach":"Safety/tolerability assessed by monitoring TEAEs, SAEs, AESIs, lab measurements, immunogenicity (ADA), ECG, hepatic ultrasound, vital signs, and physical examinations."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in average daily IV glucose/dextrose infusion rate (GIR)","definition_or_measurement_approach":"Change from baseline in average daily IV glucose/dextrose infusion rate (GIR), measured in IV infusion rate units over the PTP."}
• {"endpoint_text":"- Time to complete weaning off IV glucose administration after initiating ersodetug.","definition_or_measurement_approach":"Time-to-event measure: duration from initiation of ersodetug to complete cessation of IV glucose administration."}
• {"endpoint_text":"- Change from baseline in average daily total IV glucose delivery (g).","definition_or_measurement_approach":"Change from baseline in average daily total IV glucose delivered, measured in grams."}

Methods

• Cross-border recruitment materials (K2 Cross Border letter for potential participant and Cross Border Recruitment materials) aimed at potential participants across concerned Member States (France and Netherlands).
• Physician/Investigator letters and checklists to referring physicians (K2 'Letter and Checklist for Physician').
• GP letters (L2_GP Letter files) to general practitioners.
• Email communications to potential participants (L2_Email Comm_Scout files).
• Participant brochures, study brochures and mailers (L2_Study Brochure, Reloadable ScoutPass Brochure, Reloadable ScoutPass Mailer).
• Participant card distribution (L2_Participant Card).
• Participant concierge support services (Scout Clinical listed as 'Participant concierge' in third parties).
• Use of local-language materials (French and Dutch recruitment documents and ICFs) for country-specific recruitment.

Netherlands

Earliest CTIS Part Ii Submission Date

09-07-2025

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

231

Number Of Sites

1

Number Of Participants

6

France

Earliest CTIS Part Ii Submission Date

09-07-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

229

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Rezolute Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Ergomed Clinical Research Inc.

Responsibilities

codes 1, 10, 12, 15 (Site management), 5

Name

PPD Laboratories

Responsibilities

code 4

Name

PCI Pharma Services

Responsibilities

code 14

Third parties

• {"country":"United States","full_name":"PPD Laboratories","duties_or_roles":"code 4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant concierge","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO provider","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ergomed Clinical Research Inc.","duties_or_roles":"codes 1, 10, 12, 15 (Site management), 5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WEP Clinical","duties_or_roles":"code 8","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"PCI Pharma Services","duties_or_roles":"code 14","organisation_type":"Industry"}
• {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"codes 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}