CTRI/2023/04/051609尚未招募2 期
A Phase 2 Open-Label Basket Study of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Subjects with Advanced and Early-Stage Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •1. The subject (or legally acceptable representative if applicable) provides written
- •informed consent for the trial.
- •2. >=18 years of age on the day of signing the informed consent.
- •3. A male subject must agree to use contraception and refrain from sperm donation
- •during the treatment period and for at least 60 days after the last dose of study
- •4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and
- •at least one of the following conditions applies:
- •a) Not a WOCBP
- •b) A WOCBP who agrees to follow contraceptive guidance during the treatment
- •period and for at least 60 days after the last dose of study treatment
- •5. Have an ECOG performance status of 0 to 1.
- •6. Have a life expectancy of at least 3 months.
- •7. HIV-infected subjects are eligible but must be on ART and have well-controlled HIV
- •infection/disease defined as:
- •a) Subjects on ART must have a CD4+ T cell count >350 cells/mm3 at time of
- •b) Subjects on ART must have achieved and maintained virologic suppression
- •defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of
- •qualification (below the limit of detection) using the locally available assay at the
- •time of screening and for at least 12 weeks prior to screening.
- •c) Subjects on ART must have been on a stable regimen, without changes in drugs
- •or dose modification, for at least 4 weeks prior to study entry (Day 1).
- •8. Subjects who are HBsAg positive are eligible if they have received HBV antiviral
- •therapy for at least 4 weeks and have undetectable HBV viral load prior to
- •randomization.
- •NOTE: Subjects should remain on anti-viral therapy throughout study intervention
- •and follow local guidelines for HBV anti-viral therapy post completion of study
- •intervention.
- •NOTE: Hepatitis B screening tests are not required unless:
- •Known history of HBV infection,
- •As mandated by local health authority.
- •9. Subjects with history of HCV infection are eligible if HCV viral load is undetectable
- •at screening.
- •NOTE: Subjects must have completed curative anti-viral therapy at least 4 weeks
- •prior to randomization.
- •NOTE: Hepatitis C screening tests are not required unless:
- •Known history of HCV infection,
- •As mandated by local health authority
排除标准
- •Core Exclusion Criteria
- •Subjects are excluded from the study if any of the following criteria apply:
- •Pregnancy Exclusion:
- •1. A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to
- •treatment. If the urine test is positive or cannot be confirmed as negative, a serum
- •pregnancy test will be required.
- •Prior/Concomitant Therapy:
- •2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or
- •with an agent directed to another stimulatory or co-inhibitory TCR (e.g., LAG-3,
- •CTLA-4, OX40, CD137)
- •3. Has received prior systemic anti-cancer therapy including investigational agents
- •within 28 days prior to treatment.
- •4. Recovery from all AEs due to previous therapies to <=Grade 1 or baseline, with the
- •exception of alopecia.
- •NOTE: Subjects with Grade <=2 neuropathy and subjects with endocrine-related
- •AEs Grade <=2 requiring treatment or hormone replacement may be eligible after
- •discussion with the Sponsorâ??s Medical Monitor.
- •NOTE: If the subject had major surgery, the subject must have recovered
- •adequately from the procedure and/or any complications from the surgery prior to
- •starting study intervention.
- •5. Has received prior radiotherapy within 2 weeks of start of study treatment.
- •Subjects must have recovered from all radiation-related toxicities, not require
- •corticosteroids, and not have had radiation pneumonitis. A 1-week washout is
- •permitted for palliative radiation (<=2 weeks of radiotherapy) to non-CNS disease.
- •6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose
- •of study intervention.
- •NOTE: Administration of killed vaccines are allowed.
- •Prior/Concurrent Clinical Study Experience:
- •7. Is currently participating in or has participated in a study of an investigational
- •agent or has used an investigational device within 4 weeks prior to the first dose
- •of study treatment.
- •NOTE: Subjects who have entered the follow-up phase of an investigational
- •study may participate as long as it has been >28 days after the last dose of the
- •previous investigational agent.
- •8. Has undergone prior allogeneic hematopoietic stem cell transplantation within the
- •last 5 years (Subjects who have had a transplant greater than 5 years ago are
- •eligible as long as there are no symptoms of GVHD).
- •9. Has had an allogeneic tissue/solid organ transplant.
- •Diagnostic Assessments:
- •10. Subject is, in the opinion of the treating physician, deemed at high risk of fatal
- •outcome in case of COVID-19.
- •11. Subjects with a history of COVID-19 and have not provided a negative test for
- •SARS-CoV-2 infection within 28 days of the planned first dose date with FS118.
- •12. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
- •therapy (dosing exceeding 10 mg daily of prednisone or equivalent) or any other
- •form of immunosuppressive therapy within 7 days prior the first dose of study
- •13. Has a known additional malignancy that is progressing or has required active
- •treatment within the past 3 years.
- •NOTE: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma
- •of the skin, transitional cell carcinoma of u
研究者
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