CTIS2023-503731-18-00进行中（未招募）1 期
An Open Label, Phase 1/2 Study of HST-1011 Given as Monotherapy and in Combination with an Anti-PD1 Antibody in Patients with Advanced Solid Tumors - Clin-001
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
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Phase 1 Parts A1, A2, B1, B2:, 9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening and prior to dosing on C1D1., 10. Female patients: If of childbearing potential: • Must have a negative serum pregnancy test within 14 days prior to the first dose of study drug C1D1 AND • If heterosexually active, must commit to using 2 highly effective forms of birth control (Appendix 5) and must not donate oocytes for the duration of the study and for 4 months following the last dose of HST-1011. For Part B1 and Part B2, where patients will receive a combination of HST-1011 and cemiplimab, birth control and prohibition of oocyte. ...., 11. Male patients: • If heterosexually active with a partner of child-bearing potential as defined in inclusion criteria #10, must commit to the use of a highly effective method of birth control (Appendix 5) and not donate sperm for the duration of the study and for 4 months following the last dose of HST-1011 or for 6 months following the last dose of cemiplimab OR • Must be sterile (biologically or surgically), 12. Patient’s last dose of previous systemic anticancer therapy or major surgery must be = 21 days prior to the first dose of HST-1011 or the last dose of therapy with a small molecule therapy must be either = 5 times the half-life of the therapy OR = 21 days prior to the first dose of study treatment, whichever is shorter. Note that gonadal suppression or endocrine therapy for patients with prostate cancer, a prior breast or ovarian cancer, or an elevated genetic risk of specific cancers should be discussed with the Sponsor Medical Monitor as these medications may be permitted on a patient-by-patient basis., 13. Patient has stopped taking all strong and moderate CYP3A4 inhibitors and inducers and proton pump inhibitors (except pantoprazole which is allowed on study) (Appendix 8) within 14 days prior to onset of HST-1011 treatment, with prior discussion with the Sponsor Medical Monitor required for approval of any exceptions. If patient requires a proton pump inhibitor, they must be switched to pantoprazole prior to onset of HST-1011 treatment to be eligible., 14. Patient has had all prior anticancer therapy toxicities resolve to = Grade 1 at the time of Screening with the following exceptions: • Alopecia • Ongoing toxicities attributed to systemic prior anticancer therapy or palliative radiation which are not expected to resolve and which result in long lasting sequelae (eg neuropathy or ototoxicity after platinum-based therapy) • Endocrinopathies from prior immunotherapy as long as patient is stable on an adequate replacement therapy, 15. Patient has a life expectancy > 12 weeks in the opinion of the Investigator., 1. Patient is at least 18 years of age., 2. Patient is capable of understanding and complying with protocol requirements., 3. Patient has signed and dated an institutional review board/independent ethics committee (IRB/IEC) approved informed consent form (ICF) before any protocol-directed screening procedures are performed., 4. Patient has a histologically confirmed advanced solid tumor (metastatic, recurrent and/or unresectable) in 1 of the following categories: a. Patient with tumor types where anti-PD-(L)1 therapies are approved, meeting one of the below criteria: • Patient must be anti-PD-(L)1 relapsed / refractory defined as having clear evidence of radiologic or clinical progression while on or within 4 months of their last anti-PD-(L)1 dose OR
排除标准
- •1. Patient has active autoimmune disease or other medical conditions (eg, active interstitial lung disease/pneumonitis or eczema, psoriasis, or other clinically significant dermatologic disorders) requiring chronic systemic steroid (> 10 mg/day prednisone or equivalent) or immunosuppressive therapy within 6 months prior to first administration of study treatment (unless agreed otherwise between the Medical Monitor and the Investigator on a case-by-case basis). Non-systemic corticosteroids (eg, topical, inhaled) or short-term, symptom-focused use of systemic corticosteroids are allowed., 19. Patient has received live vaccines within 4 weeks of first HST-1011 dose (Note: Any vaccines that do not contain live viruses are permitted)., 20. Patient has a history of a seizure within 6 months of Screening. For patients with a seizure secondary to a discrete medical event (eg metastatic disease in the CNS within 6 months of screening or a traumatic brain injury) eligibility will be determined following a discussion with the Sponsor Medical Monitor., 2. Patient has had an unacceptable intolerance to prior anti-PD-(L)1 monoclonal antibody therapy (Part B1 and Part B2 only)., 21. Patient has known or suspected active infection with SARS-CoV-2 virus., 22. Patient has any other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and/or interpretation of the current study., 3. Patient has 1 or more of the following: a. Unstable angina b. Myocardial infarction within 6 months prior to screening c. New York Heart Associate Class II or greater congestive heart failure d. QT interval corrected using Fredericia’s formula (QTcF) =470 msec obtained from the mean of 3 consecutive resting ECGs unless a patient has underlying cardiac conduction abnormalities in which an alternative correction method should be used to accurately document QTc. In this case, the alternative approach must be discussed with Sponsor Medical Monitor for approval. e. Clinically important abnormalities in rhythm, conduction, or morphology of resting ECG f. Congenital long QT syndrome g. Uncontrolled hypertension, 4. Patient has previously participated in a clinical study evaluating a CBL-B inhibitor., 5. Patient is a pregnant or lactating female., 6. Patient has received prior systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 21 days or 5 half-lives (if known), whichever is shorter, before receiving their first dose of HST-1011. Note that gonadal suppression or endocrine therapy for patients with prostate cancer, a prior breast or ovarian cancer, or an elevated genetic risk of specific cancers should be discussed with the Sponsor Medical Monitor as these medications may be permitted on a patient-by-patient basis., 7. Patient has received radiotherapy within 14 days of their first dose of HST-1011, unless discussed with Sponsor’s Medical Monitor for approval., 10. Patient is currently taking any concomitant medications at Screening that have the potential to cause a clinically relevant drug-drug interaction with HST-1011, unless discussed with Sponsor’s Medical Monitor., 8. Patient has untreated and/or symptomatic metastatic CNS disease. Note: Patients with brain/CNS metastases who have undergone surgery or radiotherapy, whose disease is stable and who have been on a stable, low dose of corticosteroids (= 10 mg prednisone or equivalent) for at least 4 weeks p
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