A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (anti-FRa antibody-drug conjugate) in Adult Patients with Recurrent Endometrial Cancer and Recurrent, High-Grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers - IMGN151-1001

Immunogen Inc.0 个研究点目标入组 259 人开始时间: 2024年4月19日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 259

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+（—）

入选标准

•Patients = 18 years of age, Completed any major surgery at least 4 weeks before the first dose of IMGN151 and have recovered or stabilized from the side effects of prior surgery before the first dose of IMGN151., Adequate hematologic, liver, and kidney functions defined as follows: a.Absolute neutrophil count (ANC) = 1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell growth factors in the prior 20 days b.Platelet count = 100 × 109/L (100,000/µL) without platelet transfusion in the prior 10 days c.Hemoglobin = 9.0 g/dL without packed red blood cell transfusion in the prior 10 days d.Estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73 m2 or an estimated creatinine clearance of = 60 mL/min e.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 × upper limit of normal (ULN) f.Bilirubin = 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN) g.Albumin = 2 g/dL, Willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements., Females of childbearing potential (FOCBP) must agree to use highly effective contraceptive method(s) while on IMGN151 and for at least 28 weeks after the last dose., For FOCBP, a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 72 hours before the first dose of IMGN151 is required., An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1., Dose-Escalation Phase: A confirmed diagnosis of recurrent endometrial cancer (endometrioid or serous histology only) or high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC). Patients will have exhausted appropriate standard-of-care therapy and be appropriate for participation in a single-agent Phase 1 study in the opinion of the investigator., Expansion Phase: a.A confirmed diagnosis of recurrent endometrial cancer (endometrioid or serous histology only) or platinum-resistant, high-grade serous EOC (PROC). Patients with PROC will have had 1-4 prior lines of therapy. Platinum-resistant disease is defined as radiographic progression within 6 months (182 days) after the last dose of the most recent platinum therapy. b.if performed previously, results of germline and/or somatic BRCA testing must be reported at study entry. Patients with tumors harboring a BRCA mutation are required to have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor if available locally and medically appropriate. Note that BRCA testing is not required for enrollment for patients who have not had it done previously. c.For patients with endometrial cancer, prior checkpoint inhibitor therapy, alone or in combination, is required if available locally and medically appropriate. Note: Progression is calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression., Prior anticancer therapy a.For Expansion Phase: Patients must have recurrent endometrial cancer or patients with PROC must have received 1-4 prior systemic lines of therapy. b.Neoadjuvant and adjuvant therapies are considered 1 line of therapy. c.Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently). d.Therapy changed due to toxicity in the absence of progression wil

排除标准

•Patients with ovarian cancer with histologies including endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, as well as low-grade/borderline ovarian tumor, Evidence of pneumonitis on baseline imaging or patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis, Prior hypersensitivity to monoclonal antibodies (mAb), Patients who are pregnant or breastfeeding, For Expansion Phase: Receipt of a prior FRa-targeting agent, with the exception of patients enrolled in the prior FRa-targeting agent, ovarian cancer cohort (Cohort C)., Untreated or symptomatic central nervous system metastases Note: Patients requiring ongoing steroids for central nervous system metastases are not eligible for enrollment., History of other malignancy within 3 years before enrollment Note: Patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible., Prior known hypersensitivity reactions to study drugs and/or any of their excipients, Radiation therapy of >20% of the potential bone marrow Note: For patients with endometrial cancer: Whole pelvic radiation (WPXRT) given in the adjuvant setting, ± vaginal cuff brachytherapy, is permitted., > Grade 1 peripheral neuropathy per CTCAE v5.0, Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as active or recurrent uveitis, uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision, Serious concurrent illness or clinically relevant active infection, including, but not limited to the following: - Active hepatitis B or C infection (whether or not on active antiviral therapy) - HIV infection in patients with CD4+ T-cell (CD4+) counts < 350 cells/µL - Active cytomegalovirus infection - Active COVID-19/SARS-CoV-2 infection. Although SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines and standards - Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before the first dose of IMGN151 Note: Testing at Screening is not required for the above infections unless clinically indicated., History of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome), Clinically significant cardiac disease including, but not limited to, any of the following: - Myocardial infarction = 6 months before the first dose - Unstable angina pectoris - Uncontrolled congestive heart failure (New York Heart Association > class II) - Uncontrolled = Grade 3 hypertension (per CTCAE v5.0) - Uncontrolled cardiac arrhythmias - QTc interval > 470 ms, History of hemorrhagic or ischemic stroke within 6 months before enrollment, History of cirrhotic liver disease (Child-Pugh Class B or C)

研究者

发起方

Immunogen Inc.

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