研究项目库 / NCT05382559

Setidegrasib用于实体瘤的I 期研究

这是一项关于实体瘤的I 期研究,登记的药物或干预包括Setidegrasib;Cetuximab;Leucovorin;Oxaliplatin;Fluorouracil;Irinotecan;Nanoparticle albumin-bound-paclitaxel;Gemcitabine;Docetaxel;Pembrolizu,当前状态为招募中。登记地点显示中国北京、Xuhui District、上海有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

一分钟看懂

这是一项关于实体瘤的I 期研究,登记的药物或干预包括Setidegrasib;Cetuximab;Leucovorin;Oxaliplatin;Fluorouracil;Irinotecan;Nanoparticle albumin-bound-paclitaxel;Gemcitabine;Docetaxel;Pembrolizu,当前状态为招募中。登记地点显示中国北京、Xuhui District、上海有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

药物或干预

Setidegrasib;Cetuximab;Leucovorin;Oxaliplatin;Fluorouracil;Irinotecan;Nanoparticle albumin-bound-paclitaxel;Gemcitabine;Docetaxel;Pembrolizumab;Cisplatin;Carboplatin;Pemetrexed;Liposomal Irinotecan · I 期

登记条件中文摘要

年龄范围:18岁及以上

登记的基本范围为不限性别,年龄18岁及以上;以下仅摘录8项专业入选条件,需结合英文原文并由研究团队确认。

登记记录列出8项主要排除条件,具体医学含义需结合英文原文并由研究团队确认。

中国哪些地方有记录

以下地点来自登记信息,不代表此刻仍有名额;请向研究中心确认最新情况。

  • Beijing Cancer Hospital · 北京
  • Fudan University Shanghai Cancer Center · Xuhui District
  • Shanghai Pulmonary Hospital · 上海

入选条件原文摘录

以下为摘录,请打开原始登记查看完整入排标准。

  • * Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog \[KRAS\] G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive standard approved therapies (no limit to the number of prior treatment regimens).
  • * For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study
  • * For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy.
  • * Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor/study medical monitor.
  • * Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • * Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
  • * Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.
  • * Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent \[defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone\] is permitted), and not have active radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<= 2 weeks of radiotherapy) to non-central nervous system disease.

联系前需要确认

请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。

查看登记信息

登记号:NCT05382559;登记信息更新于 2026-09-30;本站同步于 2026-10-08,中国中心当前名额未经人工确认。

查看原始登记记录