EUCTR2021-001488-25-ES进行中（未招募）1 期
A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects with Advanced Synovial Sarcoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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. Subject must be = 18 or = 16 years of age with a minimum body weight of 50 kg.
- •2. Subject must have a diagnosis of SS, defined by the presence of the SS18-SSX rearrangement, as confirmed by the Investigator (evidence from the diagnostic pathology of prior biopsy must be available). Subject must have advanced SS, which for the purposes of this study, is defined as any of the following:
- •Metastatic
- •Local (primary or recurrent), unresectable (with Investigator and Medical Monitor approval)
- •Subject must have been treated with = 4 regimens of systemic chemotherapies. Subjects who have undergone > 4 regimens of systemic chemotherapy may be permitted with Medical Monitor approval. Subjects must have:
- •Demonstrated progression of disease on their most recent therapy or
- •Discontinued their most recent therapy due to the potential for cumulative toxicity, intolerability or lack of continued clinical benefit, in the opinion of the Investigator.
- •Eligible subjects with progression of disease on their most recent therapy may enroll in the Dose Escalation Phase and in Arm 1 of the Dose Expansion Phase. Eligible subjects with responsive and/or stable disease on their most recent therapy may enroll in the Dose Escalation Phase and in Arm 2 of the Dose Expansion Phase.
- •3. Subject must have measurable disease by RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 10 mm with calipers and/or CT scan. Measurable lesions cannot have undergone any local treatment or radiation nor can any local treatment or radiation involving measurable lesions be anticipated.
- •4. Subject or his/her parent or legal guardian (when applicable) must be able to understand and be willing to sign an informed consent and, when applicable, subject must sign assent form.
- •5. Subject must be willing and able to comply with scheduled study visits and treatment plans.
- •6. Subject must be willing to undergo all study procedures (biopsies at baseline, at least 1 on-treatment and at EOT [unless contraindicated due to medical risk; other exceptions to this are at the discretion of the Sponsor’s Medical Monitor]), laboratory testing, and imaging approximately every 8 (or 12) weeks independent of dose delays, interruptions, and/or reductions.
- •7. Subject must have an ECOG PS of = 2.
- •Arm 2 (Dose Expansion Phase): Subject must have an ECOG PS of = 3
- •8. Subject must have a life expectancy of = 3 months.
- •Arm 2 (Dose Expansion Phase): Subject must have a life expectancy of = 2 months
- •9. Subject must have adequate venous access for IV drug administration and blood collection.
- •10. Subject must have adequate cardiac, hepatic, renal, hematologic, coagulation function as explained in the protocol.
- •11. Timing requirements with respect to prior therapy and surgery are as follows:
- •At least 2 weeks or at least 5 half-lives, whichever is shorter, must have elapsed since administration of the last dose of any prior anticancer therapy (including investigational agents).
- •4 weeks must have elapsed since the last major surgery, laparoscopic procedure, or significant traumatic injury.
- •2 weeks must have elapsed since the last radiotherapy. Palliative radiation therapy is allowed so long as it does not involve the target lesion(s).
- •12. Toxicity related to prior therapy must have returned to = Grade 1 by CTCAE at least 14 days prior to study start. Exceptions include Grade 2 alopecia and other Grade 2 toxicities de
排除标准
- •1. Subject (or his/her parent or legal guardian, when applicable) is unable to provide informed consent (or assent, when applicable) and/or to follow protocol requirements.
- •2. Subject has other malignancy which may interfere with the diagnosis and/or treatment of SS and/or interpretation of outcome results.
- •3. Subject has an active severe infection requiring systemic therapy. Subject is permitted to enroll once any required antibiotic and/or antifungal therapy has been completed and/or infection is determined to be controlled.
- •4. Subject has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections; subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Subject has known positive human immunodeficiency virus (HIV) antibody results or acquired immunodeficiency syndrome (AIDS)-related illness; subjects with CD4+ T-cell counts = 350 cells/µL will be permitted, as will subjects who have not had an AIDS-related illness within the past 12 months.
- •5. Subject has an uncontrolled concurrent medical disease and/or psychiatric illness/social situation that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol.
- •6. Subject is receiving systemic steroid therapy for acute illness (stable doses for controlled chronic disease are permitted) or any other systemic immunosuppressive medication. Local steroid therapies (inhaled or topical steroids) are acceptable. See Exclusion criterion 7 for details on steroids in the setting of central nervous system (CNS) disease.
- •7. Subjects with known CNS metastases are only permitted under the following conditions: Brain metastases must have been stable for the at least 2 months since completion of most recent CNS-directed intervention. Subject may be on corticosteroids so long as the dose is stable or decreasing at the time of study entry. Anti-epileptic therapy is allowed so long as medications are not otherwise excluded and seizures have been controlled for at least 4 weeks since the last anti-epileptic medication adjustment. Subjects with active brain metastases and/or leptomeningeal disease are excluded.
- •Dose Escalation Phase: Subjects with known CNS metastases that meet the above conditions are permitted to enroll in dose escalation.
- •Arm 1 (Dose Expansion Phase): Subjects with known or suspected CNS metastases are excluded from Arm 1.
- •Arm 2 (Dose Expansion Phase): Subjects with CNS metastases that meet the above conditions are permitted to enroll in Arm 2.
- •8. Subject has known hypersensitivities to components of FHD-609.
- •9. Subject has prior exposure to a BRD9 degrader.
- •10. Subject is participating in any other clinical trials. Exceptions include participation in any observational or nontherapeutic clinical trials.
研究者
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