NL-OMON54714招募中不适用
An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors - CTNO155X2101
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 33
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 64（—）
入选标准
- •1. >=18 years of age.
- •2. Site of disease amenable to biopsy.
- •3. ECOG performance status 0, 1, 2.
- •4. Presence of at least one measurable lesion (RECIST v1.1).
- •5. Dose escalation part:
- •Advanced NSCLC (harbouring an activating EGFR mutation), advanced HNSCC,
- •advanced GIST,KRASG12C mutant NSCLC, advanced oesophagol SCC and NRAS/BRAF WT
- •melanoma who progressed after Standard of Care (SoC) or for whom no effective
- •therapy exists) See protocol page 49 for details.
- •6. Dose expansion part:
- •Group 1: advanced RAS/BRAF wild type NSCLC.
- •Group 2: advanced RAS/BRAF wild type HNSCC.
- •Group 3: advanced RAS/BRAF wild type other malignancies with
- •RTK-dependency. Patients with NSCLC or HNSCC must have progressed on or after
- •(or intolerant to), platinum-containing combination therapy.
- •Group 4: advanced RAS/BRAF WT other solid malignancy (excl CRC), after
- •progression on standard of care. Patients with NSCLC or HNSCC must have
- •progressed on or after (or intolerant to), platinum-containing combination
- •For the first 4 groups the requirement for HRAS mutation testing may be waived
- •documented discussion with Novartis when local testing for HRAS mutations is not
- •Group 5: Advanced KRAS G12C-mutant NSCLC, after progression on or after, or
- •intolerance to SOC,
- •Group 6: advanced NRAS/BRAF WT melanoma, after progression on or after or
- •intolerance to SOC immuno-oncologic therapy.
- •See protocol page 49-50 for more details.
排除标准
- •1. Tumors harbouring known activating KRAS, NRAS, HRAS, BRAF, or PTPN11 (SHP2)
- •mutations, with the exception of KRAS G12C-mutant CRC in dose escalation and
- •G12C-mutant NSCLC in dose expansion.
- •2. Prior and concomitant anti-cancer therapies as radiotherapy, surgery,
- •immunotherapy, cytotoxic agents, chemotherapy within half-live timelines as
- •described in protocol page 38.
- •2A. No resolution of all clinically significant toxicity on prior systemicanti-
- •cancer therapy (except where otherwise stated in the protocol and alopecia).
- •2B. Malignant disease, other than that being treated in this study. Exceptions
- •to this exclusion
- •include the following: malignancies that were treated curatively and have not
- •recurred within 2 years prior to study treatment; completely resected basal
- •cell and squamous cell skin cancers;
- •3. History or current evidence of retinal vein occlusion (RVO) or current risk
- •factors for RVO.
- •4. Ongoing active diarrhoea requiring medication.
- •5. All primary central nervous system (CNS) tumors or symptomatic CNS
- •metastases which are neurologically unstable or requiring increasing doses of
- •steroids within the 4 weeks prior to study entry. See protocol page 38-39 for
- •more details.
- •6. Clinically significant cardiac disease e.g. LVEF < 50% (or below
- •institutional standard lower limit), uncontrolled hypertension, presence of
- •significant arrhythmias, QTcF > 450 msec for males and >460 msec for females -
- •See protocol page 39 for details.
- •7. Treatment with prohibited medication. See protocol appendix 2 for details. .
- •8. Insufficient bone marrow function, liver and kidney function defined by lab
- •values. See protocol page 39 and 40 for details
- •9. The following labvalues must be within the lab normal ranges of the
- •institution (and cannot be corrected with supplements): Potassium - magnesium -
- •phosphorus - total calcium - fasting glucose
- •10. Pregnancy, lactation, insufficient contraception for females of
- •childbearing potential. Males not using a condom.
- •11. Use of any live or live attenuated vaccines against infectious diseases
- •within 4 weeks
- •prior to study treatment initiation.
研究者
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