EUCTR2018-001400-11-AT进行中（未招募）1 期
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
Amgen Inc.0 个研究点目标入组 791 人开始时间: 2019年7月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 791
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.Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •2.Men or women = 18 years old
- •3.For all parts except 2e: Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing. For phase 2 Part A only, the mutation will be confirmed by central testing prior to enrollment for NSCLC and CRC tumor types only..
- •a.For NSCLC:
- •Phase 1 subjects must have received platinum-based combination therapy and/or targeted therapies (ie, if molecular testing has identified mutations in EGFR, ALK, or proto-oncogene tyrosine-protein kinase ROS [ROS1] or expression of programmed death-ligand [PD-L1]), prior to receiving AMG 510.
- •Phase 2 Part A subjects must have progressed after receiving anti-PD1 or anti-PD-L1 immunotherapy (unless contraindicated) AND/OR platinum-based combination chemotherapy AND targeted therapy if actionable oncogenic driver mutations were identified [ie, EGFR,
- •ALK, and ROS1]). Subjects in phase 2 Part A must have received no more than 3 prior lines of therapy. For all NSCLC subjects, the following guidance should be used:
- •Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
- •In locally advanced and unresectable NSCLC, disease progression on or within six months of end of prior curatively intended multimodal therapy will count as a line of therapy. If chemoradiation is followed by planned systemic therapy without documented progression between chemoradiation & systemic therapy, the entire treatment course counts as 1 line of therapy.
- •Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate line of therapy.
- •Phase 1 subjects must have received at least 2 prior systemic regimens in the metastatic setting . For those CRC subjects with tumors that are MSI-H, at least 1 of the prior systemic regimens must be treatment with either nivolumab or pembrolizumab if they were clinically able to receive inhibitors and 1 of these agents is approved for that indication in the region or country.
- •Phase 2 subjects must have progressed after receiving
- •luoropyrimidine AND oxaliplatin AND irinotecan. For those CRC
- •subjects with tumors that are MSI-H, at least 1 of the prior systemic regimens must have included an anti-PD1 therapy if they were clinically able to receive inhibitors and 1 of these agents is approved for that indication in the region or country.
- •c.For advanced solid tumor other than NSCLC or CRC or pancreatic cancer: subjects must have received at least one prior systemic therapy or be intolerant or ineligible for available therapies known to provide clinical benefit. Subjects with advanced solid tumor types other than NSCLC or CRC may be enrolled and treated in phase 1 or phase 2 without central confirmation of the KRAS p.G12C mutation.
- •d.For pancreatic cancer:Subjects with locally advanced or metastatic disease may be enrolled with or without prior treatment. Subjects may be enrolled and treated in phase 2 without central confirmation of the KRAS p.G12C mutation.
- •4.Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample collected within 5 years) or willing to undergo pre- treatment tumor biopsy. Phase 1 subjects with all tumor types and phase 2 subjects with tumor types other than NSCLC or CRC with prior molecularly confirmed KRAS p.G12C m
排除标准
- •1. Active brain metastases from non-brain tumors.
- •2. History or presence of hematological malignancies unless curatively treated with no evidence of disease = 2 years
- •3. Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia requiring medication
- •4. Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, uncontrolled inflammatory GI disease (eg, Crohn’s disease, ulcerative colitis)
- •5. Active infection requiring IV antibiotics within 1 weeks of study enrolment (day 1)
- •6. Exclusion of hepatitis infection,
- •7. Known positive test for HIV
- •8. Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria.
- •9. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy [except for subjects with breast cancer], or investigational agent) within 28 days of study day 1
- •10. Therapeutic or palliative radiation therapy within 2 weeks of study day 1. Subjects must have recovered from all radiotherapy related toxicity.
- •11. Currently enrolled in another investigational device or drug study, or less than 28 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •12. Other investigational procedures are excluded
- •13. Previous treatment with a KRASG12C inhibitor
- •14. Major surgery within 28 days of study day 1
- •15. Monotherapy with AMG 510: Men and women of childbearing potential (WOCBP) who are unwilling to practice acceptable methods of birth control during treatment and for at least 7 days (women) or 7 days (men) after receiving the last dose of AMG 510. Acceptable methods of highly effective birth control for women include sexual abstinence (refraining from heterosexual intercourse); vasectomy (women with a single male sexual partner) with testing showing there is no sperm in the semen;
- •bilateral tubal ligation or occlusion; or intrauterine device. Acceptable methods of birth control for men include sexual abstinence (refraining from heterosexual intercourse); vasectomy with testing showing there is no sperm in the semen; bilateral tubal ligation or occlusion in the partner; or a condom (the female partner should also consider a form of birth control).
- •Combination Therapy (pembrolizumab plus AMG 510): WOBCP who are unwilling to practice the above-mentioned highly effective methods of birth control during treatment with pembrolizumab plus AMG 510 and for at least 4 months after receiving the last dose of any study drug.
- •16. Women who are lactating/breast feeding or who plan to breastfeed while on study through 7 days (or 4 months if receiving combination therapy with pembrolizumab) after receiving the last dose of study drug.
- •17. Women with a positive pregnancy test.
- •18. Women planning to become pregnant while on study through 7 days (or 4 months if receiving combination therapy with pembrolizumab) after receiving the last dose of study drug
- •19. Subject has known sensitivity to any of the products to be administered during dosing
- •20. Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator’s knowledge
- •21. Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of t
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