JPRN-jRCT2031220738招募中1 期
A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation
Fujii Hisaki0 个研究点目标入组 356 人开始时间: 2023年3月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 356
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 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 or has refused standard approved therapies (no limit to the number of prior treatment regimens). For ASP3082 monotherapy escalation cohort, participants with solid tumor malignancies are allowed to be enrolled. For dose expansion cohorts, pancreatic cancer (PDAC) patients must have received no more than 2 prior lines of therapy. For ASP3082 +cetuximab cohorts, participants with colorectal cancer (CRC) are allowed to be enrolled.
- •2. 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 not more than 56 days prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the Schedule of Assessments. For dose expansion cohorts, if a participant cannot undergo a baseline biopsy procedure, an archival tumor tissue specimen (up to 5 - years prior) is required (Not applicable for the China safety cohort).
- •3. 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.
- •4. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
- •5. 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.
- •6. 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 had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<= 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- •7. Participant's adverse events (AEs) (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention.
- •8. Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained >= 14 days after any blood transfusion).
- •9. Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
- •o Not a woman of childbearing potential (WOCBP).
- •o WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.
- •10. Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after stud
排除标准
- •1. Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.
- •2. Participant has symptomatic or untreated CNS metastases. Participants with asymptomatic, treated CNS metastases are eligible.
- •3. Participant has leptomeningeal disease as a manifestation of the current malignancy.
- •4. Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
- •5. Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
- •6. Participant with active hepatitis B (including acute hepatitis B virus [HBV] or chronic HBV) or hepatitis C virus (HCV) (ribonucleic acid [RNA] detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.
- •7. Participant has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by a local health authority.
- •8. Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) < 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome.
- •9. Participant has a corrected QT interval (single electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 450 milliseconds (msec) (men) or >470 msec (women) during screening.
- •10. Participant has received prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor/degrader are eligible for the ASP3082 combination therapy cohort.
- •11. Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
- •12. Participant is expected to require another form of antineoplastic therapy while on study treatment.
- •13. Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness/social situations that would limit compliance with study requirements).
- •14. Participant has known history of COVID-19 positive polymerase chain reaction (PCR) test within 4 weeks prior to the start of study treatment.
- •15. Participant has had major surgery within 4 weeks prior to first dose of study intervention.
- •For ASP3082 Combination Therapy for colorectal cancer (CRC):
- •1. Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.
- •2. History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.
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