NL-OMON51895已完成不适用
A phase 1, first-in-human, multicenter, open-label, dose-escalation study to characterize the safety and tolerability of MP0317 in patients with relapsed/refractory advanced solid tumors - MP0317-CP101
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
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 99（—）
入选标准
- •1. Has an advanced, histologically-proven solid tumor of one of the following
- •types, and for which approved therapies have been exhausted or for which the
- •Investigator considers the patient ineligible or unable to tolerate other
- •treatments:
- •a. Colorectal cancer
- •b. Ovarian cancer
- •c. Endometrial cancer
- •d. Gastric cancer
- •e. Pancreatic cancer
- •f. Anal cancer
- •g. Cervical cancer
- •h. Head and neck squamous cell carcinoma (HNSCC)
- •i. Mesothelioma
- •j. Prostate cancer
- •k. Non-small cell lung cancer (NSCLC)
- •l. Melanoma
- •m.Urothelial/bladder cancer
- •n. Microsatellite instability high cancer of any type
- •o. Cutaneous squamous cell cancer
- •p. Breast cancer
- •2. >= 18 years of age on the day of signing informed consent
- •3. Has signed and dated written informed consent before performing any study
- •procedure, including screening
- •4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
- •5. Anticipated life expectancy >= 12 weeks by Investigator judgement
- •6. Measurable disease according to Response Evaluation Criteria in Solid Tumors
- •(RECIST) v1.1
- •7. Should agree to undergo mandatory paired (pre and on-treatment) tumor
- •biopsies and be considered to have biopsiable disease. The biopsies should be
- •performed as follows:
- •a. At least 1 tumor lesion >= 20 mm amenable to percutaneous biopsy other
- •than the target lesion(s) used to follow response as defined by RECIST v1.1.
- •b. For cutaneous or subcutaneous lesions, tumors should be >= 5 mm in
- •diameter amenable to biopsy by excisional or punch biopsies without
- •unacceptable risk of a major procedural complication.
- •c. For core needle biopsy specimens, at least 3 to 6 cores with an 18-gauge
- •needle should be collected.
- •d. The on-treatment tumor biopsy should be taken from the same lesion as
- •the pre-treatment biopsy. The biopsied lesion should be large enough to take
- •both biopsies >= 1 cm apart.
- •8. Should agree to undergo mandatory paired (pre and on-treatment) skin
- •9. At least 28 days must have elapsed between any prior major surgery and
- •screening. The following procedures are not considered major:
- •a. Obtaining the pre-treatment tumor and skin biopsies as per protocol
- •requirements
- •b. Placement of a port for central venous access
- •c. Needle, punch or excisional biopsy of a clinically or radiographically
- •detected lesion
- •10. Laboratory parameters at screening:
- •a. Hematology:
- 另有 17 项未显示
排除标准
- •1. Known hypersensitivity to excipients used in the MP0317 formulation
- •2. Autoimmune diseases, except autoimmune endocrinopathies that are stable with
- •hormone replacement therapy
- •3. Inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis,
- •interstitial fibrosis or chronic obstructive pulmonary disease (COPD) that may
- •have elevated tissue fibroblast activation protein (FAP) expression unless
- •approved after consultation with the Sponsor.
- •4. Serious illness or concomitant non-oncological disease considered by the
- •Investigator to be incompatible with participating in the protocol
- •5. Left ventricular ejection fraction of < 50% on echocardiographic exam or
- •multi-gated acquisition (MUGA) scan at screening
- •6. History or evidence of clinically significant cardiovascular disease defined
- •as at least one of the following criteria:
- •a. Evidence of poorly controlled arterial hypertension (systolic blood
- •pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
- •b. Myocardial infarction or instable angina pectoris within 6 months before
- •c. Heart failure (New York Heart Association Class III or IV)
- •d. Any cardiac arrhythmia that is not well controlled
- •e. QT corrected (QTc) prolongation >= Grade 2 (> 480 ms) at screening
- •measured on 2 separate electrocardiograms (ECG) at least 10 minutes apart
- •f. Clinically significant valvular heart disease
- •7. Severe dyspnea, pulmonary dysfunction or need for continuous supportive
- •oxygen inhalation
- •8. Arterial thromboembolic event, stroke or transient ischemia attack within 12
- •months before screening
- •9. Known central CNS metastases that are either untreated or are treated but
- •are associated with clinical symptoms (e.g. headache, convulsions); patients
- •with CNS metastasis that have been treated with radiotherapy and/or surgery are
- •eligible if they are clinically without symptoms for at least 6 weeks before
- •screening; if under treatment with corticosteroids (not exceeding 10 mg/day
- •prednisone or equivalent) and/or anticonvulsive agents, patients must be on a
- •stable dose for at least 14 days before first study drug administration.
- •10. Active uncontrolled bleeding or a bleeding diathesis
- •11. Therapy for active infection needs to be completed at least 7 days before
- •first study drug administration
- •12. Known positivity for human immunodeficiency virus (HIV) or history of HIV
- •(HIV testing is not mandatory)
- •13. Active hepatitis B (chronic or acute; HBV) defined as having a positive
- •hepatitis B surface antigen (HBsAg) test at screening. Patients with past or
- •resolved HBV infection (defined as having a negative HBsAg test and a positive
- •hepatitis B core antigen antibody test) are eligible.
- •14. Active hepatitis C (HCV) infection defined as having a positive HCV
- •antibody test followed by a positive HCV ribonucleic acid (RNA) test at
- •screening. The HCV RNA test will be performed only for patients who have a
- •positive HCV antibody test. Patients who are positive for HCV antibodies are
- •eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •15. Serious or non-healing wound, skin ulcer or non-healing bone fracture
- •16. Abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
- •within 6 months before screening
- •17. Any vaccines within 28 days before first study drug administration
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