EUCTR2016-004633-24-GB进行中（未招募）1 期
A Cancer Research UK Phase I/IIa trial of BT1718 (a Bicycle drug conjugate) given intravenously in patients with advanced solid tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- •2. Phase I, dose escalation phase (Stages 1 and 2):
- •Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient.
- •Phase IIa, expansion phase:
- •Histologically or cytologically proven advanced solid tumour of particular interest based on pre-clinical and clinical data, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase IIa expansion cohorts will be:
- •a. Squamous NSCLC cohort
- •b. Basket cohort (advanced solid tumours, excluding patients eligible for one of the other recruiting expansion cohorts)
- •c. Additional expansion cohort(s) may include squamous oesophageal cancer (if confirmed as recruiting by the Sponsor).
- •At least one measurable lesion according to RECIST criteria Version 1.1, that has had objective radiological progression on or after the last therapy
- •High MT1-MMP expression by IHC assay using archival tumour sample (mandatory fresh tumour samples for those patients without available archival tumour samples or additional analysis is deemed necessary)
- •Consent for pre-treatment and post-treatment fresh tumour biopsy sample in a minimum of eight patients in the squamous NSCLC cohort, squamous oesophageal cohort (if confirmed as recruiting by the Sponsor) and all patients in the basket cohort
- •Consent for pre-treatment and post-treatment non-tumour sample (optional) for patients having a pre and post-treatment tumour biopsy
- •Consent for pre and post treatment skin punch biopsy (optional)
- •3. Life expectancy of at least 12 weeks.
- •4. World Health Organisation (WHO) performance status of 0 - 1.
- •5. Haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.
- •Laboratory Test:Value required
- •Haemoglobin (Hb):=90.0 g/L, or =100.0 g/L if transfusion within last four weeks
- •Absolute neutrophil count (ANC):=1.5 x 10^9/L
- •Platelet count:=100 x 10^9/L
- •Bilirubin: =1.5 x upper limit of normal (ULN) (NB: >1.5 ULN acceptable if conjugated bilirubin is = 1.5 x ULN)
- •Alanine amino-transferase (ALT) , aspartate amino-transferase (AST) alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT): =2.5 x ULN (or =5 x ULN if has liver metastases)
- •Renal function:
- •Serum creatinine or calculated creatine clearance (using the Wright or Cockcroft & Gault [C&G] formula or isotope clearance measurement*: serum creatinine =1.5 x ULN or GFR =50 mL/min (uncorrected value) or GFR =50 mL/min (corrected value).
- •* Isotope clearance result to be used to confirm eligibility if calculated C&G/Wright method results in a glomerular filtration rate (GFR) of =50 mL/min.
- •6. 16 years or over at the time consent is given.
- •7. Consent to access and analyse any available archival tissue.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Radiotherapy (except for palliative reasons), systemic anti-cancer therapy (with the exception of life-long hormone suppression such as LHRH agents in prostate cancer) or investigational medicinal products during the previous four weeks (six weeks for nitrosoureas, mitomycin-C) before treatment (or first dose of an immunotherapy during the previous 12 weeks).
- •2. Prior bone marrow transplant, myeloablative conditioning, or extensive radiotherapy to greater than 25% of bone marrow, within previous eight weeks of first BT1718 dose.
- •3. Ongoing toxic manifestations of previous treatments greater than NCI CTCAE Grade 1. Exceptions to this are alopecia, amenorrhea/oligospermia and any other ongoing toxic manifestation which in the opinion of the Investigator and the Medical Advisor should not exclude the patient.
- •4. Any CNS metastases (unless had local therapy and are asymptomatic and radiologically-stable off steroids for the last four weeks).
- •5. Current or prior malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively-treated non-melanoma skin cancer, non-muscle-invasive bladder cancer, or carcinomas-in-situ are generally eligible.
- •6. Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence*, effective from the first administration of BT1718, throughout the trial and for six months afterwards are considered eligible.
- •7. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence* effective from the first administration of BT1718, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- •8. Surgery from which the patient has not yet recovered.
- •9. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- •10. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- •11. Patients with significant cardiovascular disease are excluded as defined by:
- •a. Congestive heart failure requiring therapy (NYHA III or IV) or known LVEF <40% (moderate to severe)
- •b. History of unstable angina pectoris or myocardial infarction up to six months prior to trial entry, or of current poorly controlled angina (symptoms weekly or more)
- •c. Presence of symptomatic or severe valvular heart disease (severe by local echographic criteria or AHA/ACC Stage C or D)
- •d. History of a clinically significant cardiac arrhythmia up to six months prior to trial entry (asymptomatic atrial fibrillation or first-degree heart block are permitted)
- •12. Previous known allerg
研究者
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