NL-OMON52492招募中3 期
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - GLOW
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
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
- •Waivers to the inclusion criteria will NOT be allowed.
- •General Criteria:
- •1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
- •written informed consent and privacy language as per national regulations
- •(e.g., Health Insurance Portability and Accountability Act [HIPAA]
- •Authorization for US sites) must be obtained from the subject or legally
- •authorized representative (if applicable) prior to any study-related procedures.
- •2. Subject is considered an adult (e.g., >= 18 years of age in the US) according
- •to local regulation at the time of signing the informed consent.
- •3. A female subject is eligible to participate if she is not pregnant
- •(negative serum pregnancy test at screening; female subjects with elevated
- •serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant
- •status through additional testing are eligible) and at least 1 of the following
- •conditions applies:
- •Not a woman of childbearing potential (WOCBP) as defined in [protocol
- •appendix 12.3 Contraception Requirements]
- •WOCBP who agrees to follow the contraceptive guidance as defined in [protocol
- •appendix 12.3 Contraception Requirements] throughout the treatment period and
- •9 months after the final administration of oxaliplatin and 6 months after the
- •administration of all other study drugs.
- •4. Female subject must agree not to breastfeed starting at screening and
- •throughout the study period, and for 6 months after the final study treatment
- •administration.
- •5. Female subject must not donate ova starting at screening and throughout the
- •study period, and for 9 months after the final administration of oxaliplatin
- •and 6 months after the final administration of all other study drugs.
- •6. A male subject with female partner(s) of childbearing potential:
- •must agree to use contraception as detailed in [Appendix 12.3 Contraception
- •Requirements] during the treatment period and for 6 months after the final
- •study treatment administration.
- •7. A male subject must not donate sperm during the treatment period and for 6
- •months after the final study treatment administration.
- •8. Male subject with a pregnant or breastfeeding partner(s) must agree to
- •remain abstinent or use a condom for the duration of the pregnancy or time
- •partner is breastfeeding throughout the study period and for 6 months after the
- •final study treatment administration.
- •9. Subject agrees not to participate in another interventional study while
- •receiving study drug in present study.
- •Disease Specific Criteria:
- •10. Subject has histologically confirmed diagnosis of Gastric or GEJ
- •adenocarcinoma.
- •11. Subject has radiologically confirmed locally advanced unresectable or
- •metastatic disease within 28 days prior to randomization.
- •12. Subject has radiologically evaluable disease (measurable and/or
- •non-measurable) according to RECIST 1.1, per local assessment, <= 28 days prior
- •to randomization. For subjects with only 1 evaluable lesion and prior
- •radiotherapy <= 3 months before randomization, the lesion must either be outside
- •the field of prior radiotherapy or have documented progression following
- •radiation therapy.
- •13. Subject*s tumor expresses CLDN18.2 in >= 75% of tumor cells demonstrating
- 另有 2 项未显示
排除标准
- •Waivers to the exclusion criteria will NOT be allowed.
- •Subject who meets any of the following exclusion criteria prior to enrollment
- •is not eligible for enrollment:
- •Prohibited Treatment or Therapies:
- •1. Subject has received prior systemic chemotherapy for locally advanced
- •unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may
- •have received either neo-adjuvant or adjuvant chemotherapy , immunotherapy or
- •other systemic anticancer therapies as long as it was completed at least 6
- •months prior randomization.
- •2. Subject has received radiotherapy for locally advanced unresectable or
- •metastatic gastric or GEJ adenocarcinoma <= 14 days prior to randomization and
- •has not recovered from any related toxicity.
- •3. Subject has received treatment with herbal medications or other treatments
- •that have known antitumor activity within 28 days prior to randomization.
- •4. Subject has received systemic immunosuppressive therapy, including systemic
- •corticosteroids within 14 days prior to randomization. Subject using a
- •physiologic replacement dose of hydrocortisone or its equivalent (defined as up
- •to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone)
- •receiving a single dose of systemic corticosteroids, or receiving systemic
- •corticosteroids as premedication for radiologic imaging contrast use is
- •5. Subject has received other investigational agents or devices within 28 days
- •prior to randomization.
- •Medical History or Concurrent Disease:
- •6. Subject has prior severe allergic reaction or intolerance to known
- •ingredients of zolbetuximab or other monoclonal antibodies, including humanized
- •or chimeric antibodies.
- •7. Subject has known immediate or delayed hypersensitivity, intolerance or
- •contraindication to any component of study treatment.
- •8. Subject has prior severe allergic reaction or intolerance to any component
- •9. Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE:
- •Screening for DPD deficiency should be conducted per local requirements.)
- •10. Subject has a complete gastric outlet syndrome or partial gastric outlet
- •syndrome with persistent/recurrent vomiting.
- •11. Per investigator judgement, subject has significant gastric bleeding and/or
- •untreated gastric ulcers that exclude the subject from participation.
- •12. Subject has a known history of a positive test for human immunodeficiency
- •virus (HIV) infection or known active hepatitis B (positive HBs Ag) or C
- •infection. NOTE: Screening for these infections should be conducted per local
- •requirements.
- •a. For subjects who are negative for HBs Ag, but HBc Ab positive, an HB DNA
- •test will be performed and if positive, the subject will be excluded.
- •b. Subjects with positive hepatitis C virus (HCV) serology but negative HCV RNA
- •test results are eligible.
- •c. Subjects treated for HCV with undetectable viral load results are eligible.
- •13. Subject has an active autoimmune disease that has required systemic
- •treatment within the past 3 months prior to randomization.
- •14. Subject has active infection requiring systemic therapy that has not
- •completely resolved within 7 days prior to randomization.
- •15. Subject has significant cardiovascular disease, including any of the
- •a. Congestive heart failure (defined as New York Heart Association [NYHA] Class <br
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