C4391001 - A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS - C4391001

Pfizer Inc.0 个研究点目标入组 337 人开始时间: 2024年5月14日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 招募中
发起方: Pfizer Inc.
入组人数: 337

研究概览入排标准研究者记录与标识符相似试验

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. Disease requirements for Part 1 a. Part 1B and Part 1C: - Refractory HR-positive/HER2-negative (2L+ with prior CDK4/6) breast cancer. b. Part 1A, Part 1D and Part 1E will include the above and: ? Refractory HR-positive/HER2-positive breast cancer. ? Tumors other than BC: NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests c. Part 1F: - Histological or cytological diagnosis of prostate cancer that has progressed from last therapy as per PCWG3., Adequate liver function, as evidenced by: a. Total serum bilirubin =1.5 × ULN unless the participant has documented Gilbert syndrome (in which case, up to total serum bilirubin =3.0 × ULN will be allowed); b. AST and ALT =2.5 × ULN; =5.0 × ULN if there is liver involvement by the tumor; c. ALKP =2.5 × ULN (=5.0 × ULN in case of bone or liver metastasis)., Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1 except for AEs not constituting a safety risk as determined by the investigator., Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures, Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol., Women of any menopausal status are allowed; however, women who are not considered post-menopausal are allowed to enroll if amenable to be treated with the LHRH agonist goserelin. Patients must have commenced treatment with goserelin or an alternative LHRH agonist at least 4 weeks prior to enrollment. If patients have received an alternative LHRH agonist prior to study entry, it is preferable to switch to goserelin for the duration of the trial. However other LHRH antagonists, such as leuprolide is acceptable., 2. Disease requirements for Part 2 Part 2A, 2B and Part 2C: a. HR-positive/HER2-negative breast cancer Part 2D: ? Histological or cytological diagnosis of castration resistant prostate cancer that has progressed from last therapy as per PCWG3., 3. Lesion requirements a. For Part 1: participant must have evaluable lesion (including skin or bone lesion only). b. For Part 2A, 2B and Part 2C: participants must have measurable disease as defined per RECIST version 1.1. Tumor lesions previously irradiated or subjected to locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented. c. For Part 2D: Participants with evaluable disease by PCWG3. Participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded., 4. Prior Systemic Treatment: a. For Part 1: •?HR-positive/HER2-negative Breast Cancer (Part 1A/Part 1B/Part 1C/ Part 1D/Part 1E): •?Participants should have received: •?at least 1 line of SOC, including CDK4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are available but not considered appropriate in the opinion of the investigator, participants may be enrolled if a compelling clinical rationale is provided by the investigator and approved by the sponsor. or •?at least 1 line of anti-endocrine therapy in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease. •?Participants in Part 1C who received fulvestrant as part of the last prior therapy are eligible. See Section 6.1.1.3. Prior chemotherapies for advanced disease settin

排除标准

•For Part 1D only: Participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast (water permitted) or consumption of the high fat, high calorie meal., Participation in other studies involving investigational product(s) within 4 weeks (or 5 half-lives, whichever is shorter) prior to study entry., Previous high-dose chemotherapy requiring stem cell rescue., Active and clinically significant bacterial, fungal, or viral infection, including but not limited to HBV, HCV, known HIV or AIDS- related illness. In equivocal cases, with positive serology, those participants with a negative viral load are potentially eligible provided the other entry criteria are met (refer to Table 1)., Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >470 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of active myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >470 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant’s eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants. Cases must be discussed in detail with sponsor’s medical monitor to judge eligibility., Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), serious conduction system abnormalities (eg, bifascicular block (defined as right bundle branch and let anterior or posterior hemiblock), 3rd degree AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; deep venous thrombosis; arterial occlusive disease; ongoing cardiac dysrhythmias of NCI CTCAE Grade =2, atrial fibrillation of any grade that is uncontrolled, or QTcF interval >470 msec at screening., Blood pressure (=150/90 mmHg despite optimal medical therapy) that cannot be controlled., Therapeutic dose of anti-coagulant treatment is prohibited (prophylactic doses of anticoagulant are allowed)., Known abnormalities in coagulation such as bleeding diathesis., Known or suspected hypersensitivity to active ingredient/excipients of PF-07220060, letrozole, fulvestrant, enzalutamide and/or goserelin (or equivalent agent to induce chemical menopause/chemical castration)., Active inflammatory GI disease, known diverticular disease or previous gastric resection or lap band surgery. Impairment of GI function or GI disease that may significantly alter the absorption of PF-07220060, such as history of GI surgery which may result in intestinal blind loops and clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE Grade >1., For Part 2B, ? Prior neoadjuvant or adjuvant treatment with a non

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发起方

Pfizer Inc.

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