NL-OMON52968尚未招募不适用
Phase I/Ib, open-label, multiple ascending dose, first-in-human study, to investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors - INT-1B3
InteRNA Technologies B.V.0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient provided a signed written informed consent before any screening
- •2. Patient with (a) lesion(s) assessable for sequential biopsies (baseline and
- •on treatment)
- •3. Patient is male or female, >=18 years of age (adult patients)
- •4. Patient with histologically or cytologically confirmed advanced and/or
- •metastatic solid tumor, with progressive disease at baseline, for whom no
- •standard treatment is available or who have declined standard therapy
- •5. Patient with evaluable disease per RECIST v1.1, iRECIST or mRECIST (for HCC
- •6. Patient with a predicted life expectancy of * 12 weeks
- •7. Patient with Eastern Cooperative Oncology Group (ECOG) performance status of
- •Grade 0 - 1
- •8. Patient with hemoglobin >= 9.0 g/dL, platelet count >= 75×109/L, and absolute
- •neutrophil count >= 1.0×109/L
- •9. Patient with adequate renal function (creatinine level within normal
- •institutional limit defined as CrCl (corrected for body surface area (BSA)) or
- •calculated creatinine clearance >= 50 mL/min/1.73 m2 (CKD-EPI calculation, see
- •Appendix 11.1)
- •10. Patient with adequate liver function (aspartate transaminase and/or alanine
- •transaminase <3 times institutional upper limit of normal (ULN) (or <= 5 times
- •ULN for patients with liver metastases), total bilirubin <= 1.5 times ULN (or <=
- •3 x ULN for patients with Gilbert*s disease)
- •11. Patient with adequate coagulation tests: international normalized ratio or
- •prothrombin time (PT) and activated partial thromboplastin time (aPTT) within
- •1.5 times ULN
- •12. Female patient of childbearing potential (defined as < 12 continuous months
- •of amenorrhea with no identified cause other than menopause or not surgically
- •sterile), must have a negative pregnancy test within 7 days before first
- •administration of study medication and agree to use highly effective methods of
- •contraception during the treatment until 60 days after the last administration
- •of the study medication.
- •Examples of highly effective contraceptive methods with a failure rate of < 1%
- •per year include bilateral tubal ligation, male sterilization, hormonal
- •contraceptives that inhibit ovulation, hormone-releasing intrauterine devices,
- •and copper intrauterine devices. Hormonal contraceptive methods must be
- •supplemented by a barrier method
- •The reliability of sexual abstinence should be evaluated in relation to the
- •duration of the clinical study and the preferred and usual lifestyle of the
- •patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or
- •post ovulation methods) and withdrawal are not acceptable methods of
- •contraception
- •13. Male patients with a female partner of childbearing potential must agree to
- •remain sexually abstinent or use adequate contraception (agreement to use a
- •barrier method of contraception) during the treatment phase and 60 days after
- •the last dose of the study medication. In addition, male patients must be
- •willing to stop sperm donation during this time
- •14. Patient is able and willing to comply with the protocol and the
- •restrictions and assessments therein.
- •Additional inclusion criteria for dose-expansion phase (Phase Ib):
- •15. Patient with measurable disease per RECIST v1.1, iRECIST or mRECIST (for
- •HCC) and at least 1 (additional) lesion accessible for sequential biopsies
- 另有 2 项未显示
排除标准
- •1. Patient on any other anti-cancer therapy (cytotoxic, biologic or
- •investigational agents), unless at least 4 weeks (or 5 half-lives, whichever is
- •shorter, 6 weeks for mitomycin-C or nitrosoureas), have elapsed since the last
- •dose before the first administration of INT-1B3 At least 2 weeks should have
- •elapsed since receiving non-palliative radiotherapy. Chronic treatment with
- •non-investigational gonadotropin-releasing hormone analogs or other hormonal or
- •supportive care is permitted
- •2. Patient with known central nervous system (CNS) metastases, unless
- •previously treated and well-controlled for at least 1 month (defined as
- •clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks
- •3. Patient with concomitant second malignancies unless curatively treated at
- •least 2 years before study entry with no additional therapy required or
- •anticipated to be required during the study period
- •4. Patient with major surgery within 5 weeks before initiating treatment or
- •with minor surgical procedure within 7 days before initiating treatment (except
- •for port-a-cath placement or biopsy)
- •5. Patient with active autoimmune disease or persistent immunemediated
- •toxicity caused by immune checkpoint inhibitor therapy of grade >= 2 (patients
- •with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism in
- •remission, or with a stable dose of hormone-replacement, vitiligo, or psoriasis
- •not requiring systemic therapy (>10mg prednisone equivalent) or controlled Type
- •1 diabetes mellitus, may be included)
- •6. Patient with toxicity (except for alopecia) related to prior anti-cancer
- •therapy and/or surgery, unless the toxicity is either resolved, returned to
- •baseline or Grade 1 (or are allowed according to other in/exclusion criteria)
- •7. Patient with any active neuropathy > Grade 2 (National Cancer Institute
- •Common Terminology Criteria for Adverse Events [CTCAE] v5.0)
- •8. Patient with a history of life-threatening (Grade 4) toxicity related to
- •prior immune therapy or severe (Grade 3) toxicity that resulted in permanent
- •discontinuation after rechallenge with immune therapy
- •9. Patient with any condition requiring concurrent use of systemic
- •immunosuppressants or corticosteroids at a daily dose > 10 mg prednisone
- •equivalent or other immunosuppressive medications within 14 days of study
- •medication administration (permitted: premedication for i.v. contrast,
- •treatment with a short course of steroids (< 5 days) up to 7 days before
- •initiating study medication, and topical glucocorticoids, or steroid
- •replacement doses for adrenal or pituitary insufficiency)
- •10. Patient with evidence of active infection that requires systemic
- •antibacterial, antiviral, or antifungal therapy <= 7 days before the first dose
- •of study medication
- •11. Patient with uncontrolled or significant cardiovascular disease including,
- •but not limited to, any of the following:
- •a) Left ventricular ejection fraction (LVEF) <= 50 % determined by
- •echocardiogram or multi-gated acquisition (MUGA) scan
- •b) High risk or uncontrolled clinically significant arrhythmias (such as atrial
- •fibrillation and conduction disorders, ventricular tachycardia, ventricular
- •fibrillation, or torsade de pointes)
- •c) Treatment with drugs that are generally considered to have a high risk of
- •causing torsade de pointes (it will b
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