CTIS2023-504251-27-00招募中1 期
A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE). - PMV-586-101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 114
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 65+（—）
- 性别
- All
入选标准
- •1. Patient is at least 18 years of age., 10. Patients who are males must be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, or use a male condom when having sexual intercourse with a female partner of childbearing potential who is not currently pregnant in order to prevent delivery of the drug via seminal fluid. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. In addition to male condom use, a highly effective method of contraception as described in inclusion criterion 9 must be used by a female partner of childbearing potential starting with the first dose of study drug through 3 months after the last dose of study drug. Males must also refrain from donating sperm during the course of the study and for at least 3 months after the last dose of study drug., 11. Patients must be willing to undergo a tumor biopsy during screening for NGS if an archival tumor specimen is not available and if the procedure is in line with standard of care (i.e., of low risk to patient and the tumor is of sufficient size to be biopsied)., 12. Patient has a life expectancy of at least 3 months as assessed by the Investigator., 13. Measurable disease per RECIST v1.1 as assessed by the Investigator, with the last imaging performed within 28 days before C1D1., 2. Patient understands the study procedures and agrees to participate by giving written, signed, and dated informed consent prior to any mandatory study-specific procedures, sampling, or analysis., 3. Patient has an ECOG status of 0 or 1, 4. Patient has a histologically or cytologically confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation identified through Sponsor-approved NGS molecular test performed at a CLIA certified (or equivalent) laboratory., 5. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease and have documented progression during or after their most recent line of anticancer therapy, or in the opinion of the Investigator are ineligible for appropriate standard of care therapy. 5a. Patients with ovarian cancer must be platinum resistant defined as disease progressing within 6 months of platinum-based chemotherapy or platinum-refractory defined as disease progressing during therapy or within 4 weeks after last dose., 6. Patients with CRPC must have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analog or inhibitor, or orchiectomy (medical or surgical castration)., 7. Patient has adequate organ function as defined as: • Hepatic: total bilirubin = 1.5 x upper limit of normal (ULN) or direct bilirubin = 1.5 x ULN for patients with Gilbert’s syndrome, ALT and AST = 3.0 x ULN for patients without liver metastasis and = 5.0 x ULN for patients with liver metastasis; albumin > 3g/dl. • Renal: Estimated Glomerular Filtration Rate (eGFR) must be = 40 mL/min. • Bone marrow: ANC = 1.5 x 109/L, platelet count = 100 x 109/L, and hemoglobin = 9 g/dL. • Serum potassium, calcium, magnesium, and phosphorus within normal limits or = Grade 1. If values are low on the initial screening assessment, supplements may be given and values repeated to confirm within normal limits or = Grade 1., 8. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first dose of study drug or be of non-childb
排除标准
- •1. Patient has received prior chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 21 days or 5 half-lives (if half-life is known), whichever is shorter, before receiving their first dose of study drug., 10. Patient with dysphagia that could interfere with the ability to swallow tablets., 11. Patient has a history of prior organ transplant., 12. Patient has any medical condition that would, in the Investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures., 13. Patient has any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer., 14. Patient has a known, active uncontrolled Hepatitis B infection (i.e., viral load above the limit of quantification), Hepatitis C infection (i.e., viral load above the limit of quantification), or human immunodeficiency virus infection (viral load > 400 copies/mL). Patients whose viral load is controlled should be on established non-CYP3A4 mediated antiretroviral therapy for at least 4 weeks prior to receiving their first dose of PC14586., 15. Female patients that are breastfeeding or bottle feeding with their breast milk., 16. Patient has any unresolved toxicities from prior therapy greater than Grade 1 at the time of starting PC14586 treatment with the exception of alopecia and Grade 2 prior chemotherapy induced neuropathy., 17. Patient has had major surgery within 2 weeks prior to the planned start of PC14586 treatment., 18. Patient has a known KRAS mutation, defined as a single nucleotide variant (SNV)., 2. Patient has received radiotherapy within 14 days., 3. Patient has a primary CNS tumor., 4. Patient has history of leptomeningeal disease or spinal cord compression., 5. Patient has brain metastases. Exception: Patients with brain metastases are permitted if they are neurologically stable and do not require steroids to treat associated neurological symptoms., 6. Patient has had a stroke or transient ischemic attack within 6 months prior to screening., 7. Patient has had one or more of the following cardiac criteria: • Unstable angina • Myocardial infarction within 6 months prior to screening • New York Heart Association Class II or greater congestive heart failure • QT interval corrected (QTc) using Fridericia’s formula (QTcF) > 470 msec obtained as the mean from 3 consecutive resting ECGs. Exception: A QTcF value corrected for wide QRS > 120 msec (QTcFBBB) should be used in place of QTcF for patients with non-clinically significant wide QRS > 120 msec due to a pacemaker or bundle branch block • Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) • Congenital long QT syndrome • Uncontrolled hypertension, 8. Patient treated with any of the following medications prior to receiving PC14586 within the below time windows: • Strong CYP3A4 inhibitors or inducers within 14 days of first dose of PC14586 • Inhibitors of P-gp or BCRP within 7 days of first dose of PC14586 • Proton pump inhibitors (PPI) within 2 days of first dose of PC14586. It is recommended to transition patients from PPI to another class of acid reducing agents (e.g., histamine H2 receptor antagonists [H2RAs]) at least 7 days prior to first dose of PC14586., 9. Patient has a history of GI disease that may interfere with absorption of
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