A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

Iksuda Therapeutics Ltd.14 个研究点分布在 4 个国家目标入组 165 人2023年9月14日

适应症Breast Cancer Gastric Cancer Gastroesophageal-junction Cancer

干预措施IKS014

概览

阶段: 1 期
干预措施: IKS014
疾病 / 适应症: Breast Cancer
发起方: Iksuda Therapeutics Ltd.
入组人数: 165
试验地点: 14
主要终点: Recommended Phase 2 Dose (Part 1)
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

详细描述

The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended phase 2 dose (RP2D); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the RP2D.

注册库

clinicaltrials.gov

开始日期

2023年9月14日

结束日期

2027年9月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

Iksuda Therapeutics Ltd.

责任方

Sponsor

入排标准

入选标准

•HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).
•Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
•Platelets ≥ 75,000 /mcL
•Hemoglobin ≥ 9.0 g/dL
•Absolute neutrophil count ≥ 1000/mcL
•No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration
•Creatinine clearance \> 45/mL/min (using the Cockcroft-Gault equation)
•Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present
•Total bilirubin ≤ 1.5 x ULN if no liver metastases or \< 3 x ULN with Gilbert's Syndrome or liver metastases at baseline
•Albumin \> 2.5 g/dL

排除标准

•History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
•Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.
•Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.
•Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.
•Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.
•Participant must not use contact lenses while participating in this study.
•Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed.
•Active second malignancy or history of another malignancy within the last 2 years with the exception of:
•Treated, non-melanoma skin cancers
•Treated carcinoma in situ (CIS) (e.g., breast, cervix)

研究组 & 干预措施

Dose Expansion: HER2 Solid Tumor Cancer Participants

Each patient will receive IKS014 at the recommended dose defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

干预措施: IKS014

Dose Escalation Cohort (Part 1)

Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

干预措施: IKS014