EUCTR2019-004046-16-GB进行中（未招募）1 期
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers - Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1. Participant must be = 18 years of age, inclusive, at the time of signing the ICF
- •2. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 at start of treatment
- •3. HLA-A*02:01-positive (testing by central laboratory)
- •4. PRAME-positive tumor, defined as one of the following:
- •a.Documentation of histologically confirmed diagnosis of a tumor type in which PRAME is expressed in >70% of tumors (eg, cutaneous melanoma, serous ovarian carcinoma, or endometrial carcinoma). Note: availability of an adequate tumor biopsy (as defined in the study Laboratory Manual) for retrospective PRAME testing must be confirmed during Screening
- •b.For tumor types where the frequency of PRAME expression is =70% (eg, NSCLC, SCLC, urothelial carcinoma, TNBC), and tumor types where the frequency of PRAME expression is unknown, tumor PRAME expression must be documented based on testing by the study central laboratory
- •5. Participants who are enrolling in biomarker cohorts must have disease that is amenable to biopsy and consent to undergo tumor biopsies during Screening and treatment
- •6. Participants who are enrolling in Phase 1 must have evaluable disease, and participants who are enrolling in Phase 2 must have measurable disease according to RECIST v1.1
- •7. Participants with metastatic or unresectable solid tumors are eligible for Arm A and Arm B. Participants must meet the indication-specific histology/tumor site requirements specified below:
- •- R/M melanoma: All primary sites allowed, including cutaneous, mucosal, and uveal
- •- R/M ovarian carcinoma: All histologies allowed; Includes fallopian tube and primary peritoneal cancers
- •- R/M uterine carcinoma: All histologies allowed
- •- R/M NSCLC: All histologies allowed
- •- R/M SCLC: All histologies allowed, including high-grade neuroendocrine large cell lung cancer
- •- R/M breast cancer: Triple-negative breast cancer
- •- R/M urothelial carcinoma: Tumors are allowed from renal pelvis, ureters, urinary bladder, and urethra
- •- Other R/M solid tumors: All histologies allowed (pending availability of a validated assay to assess tumor PRAME expression)
- •8. Participants must have relapsed from, are refractory to, or intolerant of all therapies listed in the protocol for their indication and study phase. These therapies must have been given for unresectable/metastatic disease or given in the adjuvant setting if disease progression occurred during or within 6 months of completing adjuvant therapy. There is no maximum limit on the number of prior therapies received. Biomarker testing requirements are shown in Table 13 in the protocol; additional biomarker test results may be requested if available but are not required for eligibility
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- 1. Presence of untreated or symptomatic CNS metastases, leptomeningeal disease, or cord compression: a. Treated CNS lesions must be radiographically stable for = 2 weeks after intervention (surgery and/or radiation); b. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to enrollment.
- •- 2. Bowel obstruction within 3 months prior to the planned first dose of study treatment.
- •- 3. Ongoing ascites requiring recurrent paracentesis (ie, at least twice within 28 days prior to the planned first dose of study treatment).
- •- 4. Presence of NCI CTCAE = Grade 2 toxicity due to prior cancer therapy.
- •- 5.Participants enrolling in Arm B with prior immunotherapy exposure must not have experienced immune-mediated AE (imAE) meeting any of the following criteria: a. Grade 4 imAE; b. imAE resulting in the discontinuation of any prior immunotherapy; c. imAE that failed initial immunosuppressive intervention; d. imAE that recurred upon rechallenge; e. Pneumonitis that required oral or IV steroids; f. Any neurological, ocular, or renal imAE.
- •- 6. Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of study intervention: a. Cellular therapies (eg, T-cell therapies): 90 days; b.Cytotoxic T-lymphocyte associated protein-4 (CTLA-4)-targeted immunotherapies (eg, ipilimumab): 28 days; c. All other immunotherapies, including PD-(L)1targeted immunotherapies (eg,atezolizumab, pembrolizumab): 21 days; d. All other systemic therapies: 14 days; e. Radiotherapy: 14 days(excepting palliative radiotherapy to a limited field, which may be administered within 14 days, eg, for a focally painful tumor mass).
- •- 7. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed = 7 days from any blood or blood product transfusion and = 14 days from any dose of hematologic growth factor: a. Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula, see Section 10.3) < 50 mL/min; b. Urine protein =2+, unless reflex testing confirms urine protein < 1 g/24h; c. Total bilirubin > 1.5 ×ULN, participants with Gilbert's syndrome are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN); d. Alanine aminotransferase > 3 × ULN; e. Aspartate aminotransferase > 3 × ULN; f. Albumin < 3.0 g/dL; g. Absolute neutrophil count < 1.0 × 109/L; h. Absolute lymphocyte count < 0.5 × 109/L; i. Platelet count < 75 × 109/L; j. Hemoglobin < 9 g/dL; k. Morning cortisol < lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses).
- •- 8. High risk of venous thromboembolism, defined as a score of = 3 points based on the criteria below (Khorana, 2008): a. Site of cancer is lung, gynecologic, or genitourinary (1 point); b. Platelet count > 350 × 109/L (1 point); c. Hemoglobin < 10 g/dL or use of erythropoiesis-stimulating agents (1 point); d. Leukocyte count > 11 × 109/L (1 point); e. Body mass index =35 kg/m2 (1 point).
- •- 9. Clinically significant pulmonary disease or impaired lung function, including any of the following: a. Pneumonitis (Grade 2 or higher) within 12 months of the first dose of study treatment; b. Ongoing requirement for intermittent or continuous supplemental oxygen; c. Resting oxygen saturation at Screening <94% on room air; d. Thromboembolic event (eg,
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