A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors - EDO-S101-1002

MUNDIPHARMA RESEARCH LIMITED0 个研究点目标入组 70 人开始时间: 2021年6月4日最近更新: 2022年3月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: MUNDIPHARMA RESEARCH LIMITED
入组人数: 70

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Patient willing and able to sign the informed consent; Age at least 18 years; Life expectancy >3 months; Histologically confirmed diagnosis of advanced or metastatic solid tumors, progressed during or following at least 1 previous line of therapy and no other standard therapy with benefit is available or recommended; Patients with 2° metastasis to CNS are eligible if they have had brain metastases resected or have received radiation therapy ending at least 4 weeks and they meet all the criteria: (1) Residual neurological symptoms =Grade 1 (2) No glucocorticoids requirement or patients may be receiving low doses of glucocorticoids providing the dose has been stable for at least 2 weeks prior to starting the trial (3) No progression of treated lesions and no new lesions; Disease measurable on imaging as assessed by RECIST version 1.1; Discontinuation of previous cancer therapies at least 3 weeks; ECOG performance status =2; ANC >1,000/ µL; Platelets =100,000 / µL; AST/ALT =3× ULN. If liver ALT/ AST =5× ULN; Bilirubin =1.5 mg/dL; Creatinine =1.5 ULN; Serum potassium and magnesium at least above the lowest limit of normal;
•Cohort 1: 1. Confirmed limited or extensive disease stage of SCLC; 2. At least 1 line of prior combination chemotherapy or biological therapy and no other standard therapy with benefit is available or recommended; 3. At least 3 weeks since prior treatment; 4. Prior radiotherapy acceptable if the patient has recovered from any radiotherapy related acute toxicities; 5. Disease progressing during or relapsing after the previous treatment; 6. Presence of measurable disease as defined by RECIST version 1.1.
•Cohort 2: 1. Confirmed advanced, unresectable, or metastatic STS; 2. At least 1 prior line chemotherapy or biological therapy regimen and no other standard therapy with benefit is available or recommended; 3. Disease progressing during or relapsing after the previous treatment; 4. Presence of measurable disease as defined by RECIST version 1.1
•Cohort 3: 1. Confirmed locally advanced or metastatic Triple Negative Breast Cancer; 2. At least 1 line of chemotherapy/biological therapy and no other standard therapy with benefit is available or recommended; 3. At least 3 weeks should have elapsed since prior chemotherapy; 4. Prior radiotherapy is acceptable provided it was administered at least 4 weeks before; 5. Disease progressing during or relapsing after the previous treatment; 6. Presence of measurable disease as defined by RECIST version 1.1
•Cohort 4: 1. Confirmed advanced ovarian cancer epithelial ovarian cancer; 2. At least 3 weeks should have elapsed since prior chemotherapy; 3. Disease progressing during or relapsing after the previous treatment; 4. Presence of measurable disease as defined by RECIST version 1.1
•Cohort 5: 1. Confirmed locally advanced or metastatic endometrial cancer; 2. At least one line of chemotherapy or biological therapy and no other standard therapy with benefit is available or recommended; 3. At least 3 weeks should have elapsed since prior chemotherapy; 4. Prior radiotherapy is acceptable provided it was administered at least 4 weeks prior to starting treatment; 5. Disease progressing during or relapsing after the previous treatment; 6. Presence of measurable disease as defined by RECIST version 1.1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Numb

排除标准

•Patients with primary central nervous system (CNS) cancer.
•Patients with QTc interval (Fridericia’s formula) >450 ms.
•Patients who are on treatment with drugs known to prolong the QT/QTc interval. Refer to CredibleMeds list of drugs with known risk of Torsade des pointes (TdP): http://crediblemeds.org/new-drug-list.
•Patients who are being treated with Valproic Acid for any indication (epilepsy, mood disorder).
•Any serious medical condition that interferes with adherence to trial procedures.
•Prior history of another solid tumor malignancy diagnosed within the last 3 years of trial enrollment excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment)
•Pregnant or breastfeeding women.
•New York Heart Association (NYHA) stage III/IV congestive heart failure. The following arrhythmias: atrial fibrillation/flutter with poor rate control, documented sustained ventricular tachycardia (defined as >30 seconds or requiring cardioversion before 30 seconds have elapsed) or TdP.
•Significant co-morbidities (e.g., active infection requiring systemic therapy, history of human immunodeficiency virus [HIV] infection, or active Hepatitis B or Hepatitis C).
•Use of other investigational agents within 30 days or 5 half-lives prior to the first dose of tinostamustine, provided the patient has recovered from any related toxicities =Grade 1.
•Steroid treatment within 7 days prior to trial treatment. Patients that require intermittent use of bronchodilators, topical steroids, or local steroid injections will not be excluded from the trial. Patients who have been stabilized to 10 mg prednisolone orally (PO) once daily (QD) (or equivalent), daily (or less) at least 7 days prior to Investigational Medicinal Product administration are allowed.
•Phase 2 patients must meet the cohort-specific inclusion/exclusion criteria in addition to the general inclusion/exclusion criteria previously noted.

研究者

发起方

MUNDIPHARMA RESEARCH LIMITED

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