EUCTR2021-002264-41-ES进行中（未招募）1 期
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors - First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •1. Ability to provide informed consent and documentation of informed consent prior to any study-related tests or procedures that are not part of standard of care for the participant’s disease. Participants must be willing and able to comply with study procedures.
- •2. Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous NSCLC, TNBC, CRC, gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available.
- •Note: Neoadjuvant/adjuvant systemic treatment are included in prior lines of therapy, except for TNBC where they are excluded.
- •Note: Maintenance therapies are considered part of the prior line of therapy and will not be counted as a separate line of therapy.
- •a. NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines.
- •b. TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies.
- •c. CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
- •d. Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
- •e. Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
- •3. Either non-measurable or measurable disease per RECIST v1.1 and documented by CT and/or MRI obtained within 28 days of C1D1.
- •a. Dose Escalation Phase: Participants may have non-measurable or measurable disease per RECIST v1.1.
- •b. Dose Expansion Phase: Participants must have measurable disease per RECIST v1.1.
- •4. Age > or = 18 years old.
- •5. Archival FFPE tissue must be available. Participants may undergo a fresh tumor biopsy using a low-risk, medically routine procedure to obtain a specimen for testing if a archival tumor sample is not available.
- •a. Tumor specimens for retrospective determination of ADAM9 expression via IHC staining will be collected from all participants and will be assayed at a central laboratory designated by the sponsor.
- •6. ECOG performance status of 0 or 1.
- •a. If ECOG performance status is an inappropriate performance measurement for participant enrollment (eg, chronically non-ambulatory), then Karnofsky performance status must be > or = 70.
- •7. Life expectancy > or = 12 weeks.
- •8. Acceptable laboratory parameters as follows:
- •Platelet count > or = 75 × 1^3/microL without platelet transfusion within 28 days prior to initiation of study drug.
- •Absolute neutrophil count > or = 1.5 × 1^3/microL in the absence of any growth factor support within 21days prior to initiation of study drug.
- •ALT/AST < or = 3.0 × ULN; for participants with hepatic metastases, ALT and AST < or = 5 × ULN.
- •Total bilirubin = 1.5 × ULN, except participants with Gilbert’s syndrome, who may enroll if the conjugated bilirubin is within normal limits.
- •eGFR > 30 mL/min/1.73 m^2 or an estimated creatinine clearance of > 30 mL/min.
- •Urinalysis protein and white occult blood cells within normal limits.
- •Negative serum pregnancy test for FOCBP.
- •9. FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and
- •bilateral oophorectomy) and between menarche and 1-year post menopause, must have a
- •negative serum pregnancy test performed within 72 hours prior to initiation of study drug
- •administration. Female participants must abstain f
排除标准
- •1. Participants with active central nervous system (CNS) disease within the last 6 months.
- •2. Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as 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.
- •3. Participants who had prior therapies within the specified times below:
- •Systemic antineoplastic therapy within at least 5 half-lives or 4 weeks (whichever is shorter) prior to initiation of study drug.
- •Mediastinal or pelvic radiation therapy within 6 weeks prior to initiation of study drug administration. Palliative, limited field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to initiation of study drug.
- •- Note: Previously irradiated lesions are not considered measurable disease unless they have demonstrated progression per RECIST v1.1.
- •4. Participants must have stabilized or recovered (Grade 1 or baseline) from all priortherapy-related toxicities (except alopecia).
- •5. Clinically significant cardiovascular disease including but not limited to:
- •Myocardial infarction or unstable angina within 6 months prior to initiation of study drug.
- •Stroke or transient ischemic attack within 6 months prior to initiation of study drug.
- •Current clinically significant cardiac arrhythmias, eg, atrial fibrillation that are not well controlled with optimal medical intervention.
- •Current uncontrolled hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg.
- •Current congestive heart failure (New York Heart Association class III-IV).
- •Current pericarditis or clinically significant pericardial effusion.
- •Current myocarditis.
- •LVEF of < 50% by scan.
- •QTc interval > 480 msec.
- •6. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen (excluding for sleep apnea) or history of = Grade 3 drug-induced or radiation pneumonitis.
- •7. Participants with 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).
- •Human immunodeficiency virus infection.
- •Cytomegalovirus infection.
- •Active COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards.
- •Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to initiation of study drug.
- •Note: Testing at screening is not required for the above infections unless clinically indicated.
- •8. History of prior bone marrow, stem cell, or solid organ transplantation.
- •9. Second primary invasive malignancy that has not been in remission for greater than 2 years, except nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ or similar.
- •10. Major trauma or major surgery within 4 weeks prior to initiation of study drug.
- •11. Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site.
- •12. Prior life-threatening hypersensitivity reactions to antibodies
研究者
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