OPEN, NON CONTROLLED, PARALLEL COHORTS, MULTICENTER, PHASE 2A STUDY FOR THE EVALUATION OF THE ANTITUMOR ACTIVITY OF GM102 SINGLE AGENT AND IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC COLORECTAL CANCER

GAMAMABS Pharma0 个研究点目标入组 30 人开始时间: 2018年4月5日最近更新: 2021年5月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GAMAMABS Pharma
入组人数: 30

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•Inclusion criteria
•All patients
•1. Histologically-confirmed metastatic or locally advanced colorectal adenocarcinoma.
•2. Having failed the previous line of treatment for locally advanced or metastatic disease and having received at least two systemic chemotherapy regimens for metastatic colorectal cancer; adjuvant regimen can be considered as one chemotherapy regimen for metastatic disease if the participant had disease recurrence within 6 months of completion.
•3. At least one of the tumor sites amenable to core needle biopsy (may not be the site of disease for measuring antitumor response). Patient must agree to this pre-treatment biopsy and on the principle of a second biopsy under treatment; however, if eventually the second biopsy cannot be performed, patients will continue on the study and will be considered evaluable for efficacy.
•4. At least one measurable lesion (= 1.0 cm longest diameter or = 1.5 cm in short axis for malignant lymph nodes) based on RECIST 1.1 on the screening CT-scan.
•5. Written Informed Consent forms signed.
•6. Willing and able to comply with the trial requirements.
•7. Covered by healthcare insurance in accordance with local requirements.
•Specific to each cohort:
•8. Cohort I (single agent GM102): refractory patients, having exhausted all therapeutic options.
•Cohort II (combination with trifluridine/tipiracil): patients eligible for trifluridine/tipiracil who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. Patients must have received at least 2 prior lines of standard chemotherapy for mCRC.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

排除标准

•1. Age < 18 years old.
•2. ECOG performance status = 2.
•3. Life expectancy < 12 weeks.
•4. Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or anticipation of needing such procedure while receiving study treatment.
•5. Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
•6. Concurrent treatment with any other anticancer therapy (or investigational agent) or received any anticancer therapy (or investigational agent) within 4 weeks prior to first treatment.
•7. Known severe anaphylactic or other hypersensitivity reactions to IMP and/or its excipients.
•8. Unresolved toxicity = grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum induced neurotoxicity).
•9. Serious concomitant illness, e.g. active infection requiring systemic antibiotic, antifungal or antiviral drug, or physical examination or laboratory abnormalities, that, in the opinion of the Investigator, would compromise protocol objectives.
•10. Poor bone marrow reserve as defined by WBC < 3.0 x 109/L, neutrophils < 1.5 x 109/L or haemoglobin < 9.0 g/dL or platelet count < 100 x 109/L.
•11. Poor organ function as defined by any one of the following:
•- Serum creatinine > 1.5 x ULN
•- Total bilirubin > 1.5 x ULN or > 2.5 x ULN if due to Gilbert’s syndrome
•- AST, ALT > 2.5 x ULN in the absence of liver metastasis or > 5 x ULN in case of documented liver metastasis.
•12. Pregnancy or breastfeeding.
•13. Patient with reproductive potential who does not agree to use an accepted highly effective method of contraception – per investigator’s judgment - during the study period and for at least 6 months following completion of study treatment.
•14. Patient deprived of liberty by a judicial or administrative decision, patient admitted to a hospital, social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency situation.

研究者

发起方

GAMAMABS Pharma

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