NCT07262970Available不适用
Intermediate-Size Cohort EAP for Ersodetug in Patients With Refractory Hypoglycemia Due to Tumor-Associated Hyperinsulinism (Tumor HI) Who Are Unable to Participate in a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- Rezolute
研究概览
简要总结
This expanded access program is intended to provide ersodetug, an investigational drug, to eligible participants who suffer from inadequately controlled hypoglycemia due to tumor-associated hyperinsulinism and are unable to participate in ersodetug clinical trial. Participation is open to participants who meet the eligibility criteria and for whom access to the investigational drug is deemed appropriate by the treating physician.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncontrolled hypoglycemia due to documented tumor HI (including but not limited to: insulin/pro-insulin producing pancreatic/non-pancreatic neuroendocrine tumors, insulin-like growth factor-producing NICTH) that is not adequately managed with available SoC anti-hypoglycemic therapies (per Treating Physician's judgement).
- •Inability to participate in any ersodetug clinical trial.
- •Women of childbearing potential (WOCBP) must not be pregnant or breast feeding, and must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
- •Male participants with female partner of childbearing potential must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
排除标准
- •Any unexplained out-of-range laboratory value (other than glucose) that is assessed as clinically significant impacting patient safety if enrolled by the Treating Physician. Laboratory or other abnormalities that are considered related to the underlying disease or associated therapies that do not pose additional safety risk for participation per Treating Physician may be allowed upon Medical Monitor approval.
- •Evidence of active infection including (but not limited to) human immunodeficiency virus, hepatitis B, or hepatitis C.
- •Known allergy or sensitivity to ersodetug or any component of the drug.
- •Treatment with an investigational drug or device within 30 days or 5 t½ of the investigational drug before the planned 1st dose of ersodetug, whichever is longer. However, if the Treating Physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit to outweigh the risk, then the participant may be allowed to participate. Participation in registries and/or purely diagnostic studies are allowed.
- •Any organ condition, concomitant disease (including but not limited to any psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the program (e.g., may affect absorption, distribution, metabolism, or elimination of the program drug) or that, in the opinion of the Treating Physician and/or Medical Monitor would pose an unacceptable risk to the participant in the program.
研究者
相似试验
进行中（未招募）
3 期
一项在活动性特发性炎性肌病成人受试者中探究 efgartigimod PH20 SC 有效性和安全性的研究CTR2025471130
招募中
3 期
Open-Label Extension of EryDex in A-T (OLE NEAT)2024-513618-37-00Quince Therapeutics S.p.A.49
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
招募中
3 期
Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate CancerProstate CancerNCT07260435Nick Beije400
招募中
1 期
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor PatientsNCT07260305Kangabio AUSTRALIA LTD PTY57