KCT0004139招募中未知
A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Lung Cancer
ovotech Asia Korea0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male or female participants; age = 18 years
- •2. Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression.
- •3. Arm 1 and Arm 2 participants must have a sensitizing epidermal growth factor receptor (EGFR) mutation with disease progression or treatment intolerance after one or more approved TKIs. Previous treatment with chemotherapy or PD-1/L1 therapy is not allowed.
- •4. No TKI therapy within 5 days of Cycle 1 Day 1
- •5. The last dose of previous investigational therapy is at least 4 weeks or 5 half-lives prior to Cycle 1 Day 1
- •6. Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- •8. Confirm that an archival tissue sample is available and = 24 months old; if not, a new biopsy of a tumor lesion must be obtained at screening.
- •9. Adequate organ and marrow function
排除标准
- •1. Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
- •2. Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product(s) hazardous
- •3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •4. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of etrumadenant or zimberelimab, or 6 months after the last dose of pemetrexed or carboplatin, whichever is longer.
- •5. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
- •6. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
- •7. Prior use of an adenosine pathway targeting agent.
- •8. Due to potential for drug-drug interactions with etrumadenant, participants must not have had:
- •- Treatment with breast cancer resistance protein substrates (BCRP) or P-glycoprotein (P-gp) with a narrow therapeutic window, administered orally within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
- •- Treatment with known strong cytochrome P450 3A4 (CYP3A4) inducers and strong CYP3A4 inhibitors within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
研究者
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