2024-517573-24-00尚未招募2 期
FUTURE platform trial – A phase II platform trial of futibatinib in combination with (chemo)immunotherapy in colorectal cancer and other solid tumor entities
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH10 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Objective response rate (ORR), defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response.
研究概览
简要总结
Specific for FUTURE-001: To evaluate the efficacy of futibatinib plus tislelizumab and chemotherapy in 1st-line-treatment of patients with colorectal cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient* provides signed informed consent.
- •Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Patient is ≥ 18 years at the time of given informed consent.
- •Patient has a histologically proven solid tumor: Specific for FUTURE-001: Histological or cytological confirmation of colorectal adenocarcinoma that is unresectable and/or metastatic with known RAS-, BRAF and MSI- status
- •Specific for FUTURE-001: Patient must agree to participation in the accompanying translational research program.
- •Specific for FUTURE-001: Patient did not receive previous therapy in palliative setting (1st line situation).
- •Patient has ECOG Performance status ≤
- •Patient has adequate blood count, liver-enzymes, and renal function: ANC > 1,500 cells/μL without the use of hematopoietic growth factors, Platelet count ≥ 100 x 109/L (>100,000 per mm3), Hemoglobin ≥ 9 g/dL, transfusion allowed, Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN) (or < 2 x ULN in case of liver involvement or Gilbert’s disease), AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN without existing liver metastases, or ≤ 5 x UNL in the presence of liver metastases; AP ≤ 5 x ULN, Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion, Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min
- •Patient has serum calcium and phosphate levels within normal range.
- •Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and in FUTURE-001 for at least 1 week after last dose of futibatinib, 6 months after the last dose of chemotherapy or 4 months after last dose of tislelizumab, whatever is later. Male patients should refrain from sperm donation/ cryopreservation throughout this period and male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.
排除标准
- •Specific for FUTURE-001: Patient has curative colorectal cancer.
- •Patient takes St. Johns Wort within 6 weeks prior to initiation of study treatment
- •Patient has evidence of or any ongoing ophthalmological disorders. including but not limited to, central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, and previous retinal detachment
- •Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the study.
- •Patient has a known presence of an active, uncontrollable infection.
- •Patient has active disseminated intravascular coagulation.
- •Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
- •Patient participated in another interventional clinical study within 28 days prior to study enrollment or participation in a clinical study at the same time as this study unless it is an observational/ non-interventional study or during the follow-up period of an interventional study.
- •Patient received treatment with any of the following within the specified time frame prior to the first dose of study treatment: a) Major surgery within 4 weeks (surgical incision should be fully healed) b) Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks c) Any investigational drug within 4 weeks
- •Female patients, who are pregnant or breast feeding or planning to become pregnant within up to 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment
- •Specific for FUTURE-001: Patient received prior treatment with PD (L)1 or CTLA-4 targeted treatment
- •Patient received previous FGFR-addressed therapy with an FGFR inhibitor.
- •Specific for FUTURE-001: Patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included)
- •Specific for FUTURE-001: Patient has immune deficiency or receives systemic steroid hormone therapy (> 10 mg/day prednisone or other equivalents), or other form of immunosuppressive therapy within 2 weeks prior treatment initiation
- •Specific for FUTURE-001: Patient has history of uncontrolled infection with human deficiency virus (HIV) or chronic infection with hepatitis B or C virus (HBV, HCV)
- •Specific for FUTURE-001: Patient has received a solid organ transplantation
- •Specific for FUTURE-001: Patient has history of interstitial lung disease
- •Patient has known presence of tumors other than the entity investigated in the respective cohort (FUTURE-001: colorectal cancer) or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years.
- •Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
- •Patients has history and/or current evidence of any of the following disorders: a) Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the investigator b) Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the investigator.
- •Patient receives simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone anti-cancer therapy or any other anti-cancer treatment not described in the trial protocol (excluding palliative radiotherapy only for symptom control).
- •Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.
- •Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
- •Patient shows a ≥ grade 2 neuropathy
结局指标
主要结局
Objective response rate (ORR), defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response.
Objective response rate (ORR), defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response.
次要结局
- Duration of response (DoR)
- Progression free survival (PFS) according to RECIST v1.1
- Overall survival (OS)
- Safety
- Quality of life using EORTC QLQ-C30
研究者
Prof. Dr. Thorsten Götze
Scientific
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
研究点 (10)
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