BridgeMD
A study to test the safety and efficacy of the study drug in patients with low blood sugar caused by hormones made by their tumor
EU CTIS ID: 2024-515447-36-00
What this study is testing
To evaluate the glycemic efficacy of ersodetug as measured by the number of participants able to achieve a clinically meaningful reduction in continuous glucose requirements compared to baseline.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Male or female participants of ≥18 years of age who provide written informed consent as per regulations.
- 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.
- 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).
- 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.
- 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.
You likely can't join if
- Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
- 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.
- 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.
- Known allergy or sensitivity to ersodetug or any component of the drug.
- 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.
- Estimated life expectancy (additional lifespan) due to underlying disease (tumor) as specified in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.