A Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard of care (SoC) versus standard of care alone in subjects with advanced solid tumors (BOLSTER) - LSTA1-P02

isata Therapeutics Inc.0 个研究点目标入组 80 人开始时间: 2023年5月12日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 80

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

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•1. Subjects must be = 18 years of age at time of consent and provide informed consent, 8. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have primary tumor sites of the skin, paranasal sinuses, or the nasopharynx (any histology)., 11. Inclusion Criteria First-line Cholangiocarcinoma - Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible a) Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not ampulla of Vater cancers b) For liver dominant IHC, disease must comprise < 60% of the liver parenchyma, as defined by computed tomography (CT) liver segmental volumetrics, 12. If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to randomization); both the first and second measurement must be = 1.5 x ULN; stability is defined as the second measurement being no more than one point higher than the first, 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, 3. Life expectancy = 3 months, as determined by the investigator, 4. At least one bidimensional measurable metastatic lesion assessed by RECIST 1.1. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion, or the lesion persists three months after radiotherapy. Additionally, a biopsy site should not be considered a target lesion., 5. Adequate organ and marrow function: • Platelets = 100 x 109/L (>100,000 per mm3) • WBC = 3000/µL • Absolute neutrophil count = 1.5 x 109/L • Serum albumin = 2.5 g/L • ALT and AST = 2.5 x ULN in the absence of liver metastases or < 5 x ULN in the presence of liver metastases • Bilirubin = 1.5 x ULN • Hemoglobin = 9.0 g/dL. Labs may be drawn 24 hours after a transfusion to meet this criterion. • INR < 1.5 (for patients not receiving therapeutic anticoagulation) • Adequate respiratory and cardiac function (PaO2 = 60 mm Hg or oxygen saturation = 92% on room air, and 12-lead ECG with normal tracing or non clinically significant changes that do not require medical intervention) • QT interval corrected using the Fridericia method (QTcF) < 470 ms, 6. Adequate contraception: • All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods (a primary and a secondary method – see next bullet) during the study and for a period of 6 months following the last administration of the study drug, unless subject received cisplatin whereby aforementioned contra

排除标准

•1. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: • Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment • Active infection (viral, fungal, or bacterial) requiring systemic therapy • Known active HBV, HCV, or HIV infection • Active tuberculosis as defined per local guidance • History of allogeneic tissue/solid organ transplant • Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast • Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization; Pregnant or breastfeeding, 26.Clinically significant ascites (palpable on exam, paracentesis in last 3 months preceding randomization, and/or symptomatic), 27.History of malignant bowel obstruction, 10. Creatinine clearance < 45 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL, 28.Subjects with creatinine clearance < 60 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL, 3. Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent, 4. Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, and other anti-tumor therapy within 28 days prior to randomization, 5. History or clinical evidence of CNS metastases; exceptions include: • Subjects who have completed local therapy and who meet both of the following criteria: - Subjects must be asymptomatic AND - Subjects must have no requirement for steroids 6 weeks prior to start of study treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS Metastases, UPD 6. Exclusion Criteria Second-line Head and Neck Squamous Cell Carcinoma (HNSCC) - Patients who received prior taxanes unless it was given as part of neoadjuvant, concurrent therapy in the curative intent setting and it has been more than 6 months since last dose, 7. Known allergies to taxanes or their standard pretreatments, 8. Any surgery involving the HNSCC for which the patient is being treated (except biopsies) that occurred within 28 days prior to randomization, 19. Concurrent use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication), UPD 9. Subjects who cannot discontinue any concomitant medications that are inducers or inhibitors of CYP2C8 (e.g., rifampicin, phenobarbital, s

研究者

发起方

isata Therapeutics Inc.

相似试验

进行中（未招募）

1 期

A phase II, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HP184 at 100, 200 and 400 mg doses administered orally once daily for twenty-four weeks in adult subjects with chronic spinal cord injury (CSCI)Chronic spinal cord injury

EUCTR2004-000763-98-GBAventis Pharmaceuticals Inc.240

进行中（未招募）

不适用

EUCTR2004-000763-98-DEAventis Pharmaceuticals Inc.240

进行中（未招募）

不适用

EUCTR2008-006068-12-ITASTRAZENECA122

进行中（未招募）

不适用

A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 plus Carboplatin and Paclitaxel or Placebo plus Carboplatin and Paclitaxel in Patients with Advanced Ovarian Cancer Sensitive to Platinum-based ChemotherapyPatients with advanced ovarian cancer who have relapsed following first-line platinum containing therapy (Patients may have received any other chemotherapy agent with the platinum agent). Relapse must have occurred at least 6 months after cessation of first-line treatment.MedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

EUCTR2008-006068-12-DEAstraZeneca AB122

进行中（未招募）

1 期

A randomized double-blind placebo controlled study combining EYP001a with polymerase inhibitors to improve hepatitis B cure ratesChronic Hepatitis BMedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

EUCTR2019-001629-28-PLENYO Pharma SA49