A Phase 3 Study of Ersodetug in Patients With Tumor-Associated Hyperinsulinism

Double-Blind Arm: (Ambulatory ICT and Ambulatory NICT participants)

Inclusion Criteria:

• The eligibility criteria of all participants must be evaluated by amultidisciplinary team led by the PI which must include an oncologist

• Male or female participants of ≥18 years of age who provide written informed consent

• Participants with a clinical diagnosis and laboratory confirmation of ICT or NICT,with associated hypoglycemia that is considered refractory to surgery and to usualSOC anti-hypoglycemia therapies, per investigator judgement.

• Experiencing an average of ≥ 3 hypoglycemia events per week that meet Level 2criteria and/or Level 3 criteria during the two weeks before randomization

Exclusion Criteria:

• Participants who have not previously received tumor-directed therapy (including atleast one course/trial of systemic tumor-directed therapy, as appropriate) but areconsidered appropriate for tumor-directed therapies by the investigator and/or amulti-disciplinary oncology care team.

• Initiation of, or changes to tumor directed therapies within 8 weeks prior toinitiation of study drug, or expected initiation or significant changes to thesetherapies over the course of the pivotal treatment period

• Initiation of, or significant changes to, SOC medical (e.g. diazoxide, SSAs,continuous glucagon, mTOR-Inhibitors, etc.) or supplemental enteral treatments (e.g.continuous tube feeds) used for the chronic management of hypoglycemia within 4weeks of screening (per investigator's discretion), or expected changes to SOCmedical therapies over the course of the pivotal treatment period.

• Any out-of-range laboratory value at screening (other than glucose) that is assessedas clinically significant by the investigator.

Open-Label Arm: (Hospitalized ICT and NICT participants)

Inclusion Criteria:

• The eligibility criteria of all participants must be evaluated by amultidisciplinary team led by the PI which must include an oncologist

• Male or female participants of ≥18 years of age who provide written informedconsent.

• Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemicalevidence of tHI confirmed via laboratory assessment who have failed to achieveadequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, perinvestigator judgement.

• Requiring IV glucose infusion and/or parenteral nutrition for ≥3 days for managementof uncontrolled hypoglycemia

Exclusion Criteria:

• Evidence of active infection including human immunodeficiency virus, hepatitis B, orhepatitis C (excluding immunization patterns).

• Any out-of-range laboratory value at screening (other than glucose) that is assessedas clinically significant by the investigator.

• Any organ condition, concomitant disease (e.g., psychiatric illness, severealcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or otherabnormality that itself, or the treatment of which in the opinion of theinvestigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to theparticipant in the study.