EUCTR2017-001842-82-ES进行中（未招募）1 期
Phase I/II open label dose escalation and dose expansion study of intravenous infusion of W0101, an antibody-drug conjugate, in patients with advanced or metastatic solid tumors.International, multicenter, open label study.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 316
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. Male or female subjects age = 18 years
- •2. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma), unresponsive to standard treatment or for whom no standard treatment is available or appropriate
- •Note: preferentially squamous non-small cell lung cancer, larynx carcinoma, ER positive breast cancer and soft tissue sarcomas
- •3. Formalin-fixed paraffin-embedded (FFPE) archived tumor tissue block available (cohorts A1 and A2) for retrospective assessment of IGF-1R status
- •4. ECOG performance status 0 or 1
- •5. Adequate bone marrow at screening and at baseline
- •i. Absolute neutrophil count (ANC) = 1,500/mm3
- •ii. Platelet count = 150,000/mm3
- •iii. Hemoglobin = 9g/dL(6.2 mmol/L)
- •Note: Any blood product transfusion is prohibited within 2 weeks before the first study treatment administration.
- •6. Adequate liver function at screening and at baseline
- •i. Total Bilirubin = 1.5 mg/dL (=26µmol/L, SI unit equivalent)
- •ii. AST and ALT = 3 upper limit of normal (ULN), ULN = 5 in case of liver metastasis
- •iii. For subjects with Gilbert’s syndrome: total bilirubin <2.5 ULN
- •7. Adequate renal function at screening and at baseline
- •Note: Serum creatinine = 1.5 normal institutional limits or calculated (Cockroft- Gault) creatinine clearance = 60 mL/min for subjects with creatinine levels above 1.5 normal institutional limits
- •8. Serum calcium potassium and magnesium within normal ranges as per local lab values at screening and at baseline.
- •Note: Subjects with electrolyte (calcium potassium and magnesium) grade 1 alterations considered as not clinically significant as per the investigator assessment may be eligible for the study.
- •9. Subject must have recovered from all toxicities from previous cancer therapies toxicity to at least grade 1 (except alopecia)
- •10. Subject must have measurable disease as per RECIST v1.1 criteria
- •11. Non pregnant and adequate method of contraception for female subject of child-bearing potential:
- •i. Negative serum beta human chorionic gonadotropin (ß-HCG) test or negative urine pregnancy test within 72h prior first study treatment administration.
- •ii. Use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the first study treatment administration, and agreement to go on using it during the whole duration of the study and up to 3 month after the last dose of the study treatment
- •Note: a female subject of child-bearing potential is a woman who is not permanently sterilized or not postmenopausal (post-menopausal is defined as 12 months with no menses without an alternative medical cause).
- •12. Adequate method of contraception for fertile male with a child-bearing potential partner.
- •Note: Use of double barrier contraception method (use of condom for male and effective contraception method for the partner) from the entire duration of the study to 3 months after the last dose of the study treatment.
- •13. Having signed his/her written informed consent, prior to any screening procedure
- •14. Affiliated or beneficiary of a social security system, (if applicable in the national regulation)
- •+ Expansion cohorts phase (II)
- •The same inclusion criteria listed above apply for expansion cohort phase, except for inclusion criteria 2 and 3, which are replaced by:
- •2. Subjects with histologically or cytologically confirmed advanced or metastatic specific solid tumor
排除标准
- •1. History of anti-cancer therapies within 4 weeks (or = 5 half lives for targeted agents) of initiating study treatment
- •Note: Anti-cancer therapies are defined as: major surgery, radiotherapy (palliative setting is allowed), hormone therapy (except treatment for prostatic and breast cancer), immunotherapy, any conventional cytotoxic chemotherapy or other anti-cancer treatments
- •2. Known active or uncontrolled infections (bacterial, fungal, viral including HBV and HCV infections)
- •3. Symptomatic brain metastases, CNS tumors
- •4. Symptomatic motor or sensory peripheral neuropathy (= grade 2)
- •5. Subjects having ophthalmologic abnormalities
- •Note: Ophthalmologic abnormalities are defined as subjects with monocular vision or having media opacities or any other condition that precludes monitoring of the retina or the fundus or having a history or current ophthalmology exam with retina or cornea abnormalities, especially central serous retinopathy, age related macular degeneration, retina degradation, corneal ulcers, cornea dystrophies or other pathology at the discretion of the ophthalmologist/investigator.
- •6. Active serious systemic disease (infection,organic or dysmetabolic desease)
- •7. Subjects with uncontrolled high blood pressure
- •Note: systolic blood pressure, SBP >150 mmHg and/or diastolic blood pressure, DBP > 95 mmHg despite treatment on 2 out of 3 determinations done in case that the first one meets the criterion for exclusion
- •8. Type 1 diabetes or type 2 diabetes that is poorly controlled according to the investigator’s judgment
- •i. Hb A1C = 7%
- •ii. Diabetes mellitus requiring insulin treatment
- •iii. Diabetes mellitus with clinical signs
- •iv. Fasting Plasma Glucose (FPG) = 140 mg/dL / 7.8 mmol/L
- •9. Serum albumin < 30 g/L
- •10. History of another malignancy
- •Note: except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin, or any other curatively treated malignancy that has not been treated or recurred in the prior 3 years.
- •11. Biologic therapy (eg, antibodies), including ADCs: = 4 weeks before first study treatment administration.
- •12. Participation into a clinical study of an investigational agent within 4 weeks before the first study treatment administration.
- •Note: Subjects participating in the follow up period of previous studies (with no drug administration) may be eligible for the study.
- •13. Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
- •14. QTc > 470 msec on screening ECG or congenital long QT syndrome
- •15. Subjects who have any medical condition that would, in the investigator’s judgment, prevent the subject’s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- •Note: Any severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for the study
- •16. Prior anti IGF-1R therapy
- •17. Subject liable not to comply with protocol instructions in the investigator’s opinion
- •18. Subject linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to subject himself/herself to its constraints
- •19. Subject family member or work associate (secretary, nurse, techni
研究者
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