ACTRN12623001077651尚未招募1 期
A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination with Anticancer Treatments in Patients with Solid Malignancies - Module 2.
Grey Wolf Therapeutics Pty Ltd0 个研究点目标入组 36 人开始时间: 2023年10月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Module 2A specific
- •1. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy and has received at least one line of prior therapy or has no further (or has refused) standard of care options.
- •2. Participant has measurable disease per RECIST 1.1/iRECIST.
- •Module 2B specific
- •1. Participant has cytologically or histologically confirmed locally advanced or metastatic
- •solid malignancy.
- •2. Participant has confirmed progressive disease after treatment with an anti-PD-1 or anti-
- •PD-L1 mAb, following a minimum treatment duration of 12 weeks (or at least 2 response
- •evaluations).
- •3. Participant has at least one tumour lesion amenable to serial biopsies and is willing to
- •provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST,
- •excluding the lesion(s) identified for biopsy.
- •Module 2C specific
- •Additional selection criteria for Module 2 Part C will be described in a
- •future protocol amendment.
排除标准
- •All Module 2
- •1. Prior therapy with an ERAP1 inhibitor, within any timeframe prior to the first dose of
- •study drug at Cycle 0, Day 1.
- •2. Any other malignancy not meeting inclusion criterion 1 which has been active or treated
- •within the past 3 years, with the exception of cervical intraepithelial neoplasia and nonmelanoma skin cancer.
- •3. Any unresolved toxicity (except alopecia) from prior therapy of greater than or equal to CTCAE Grade 3, prior to the first dose of IMP at Cycle 0, Day 1.
- •4. Active or documented history of autoimmune disease (within 2 years) requiring systemic immunosuppressive therapy, or participant is immunocompromised for any other reason (as determined by the Investigator).
- •5. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not
- •requiring steroids for at least 4 weeks before the first dose of IMP (if stable and requiring
- •no intervention, the participant can be enrolled in the study).
- •6. Uncontrolled seizures
- •7. Active infection requiring intravenous antibiotic, antifungal, or antiviral medication or hospital admission within 14 days prior to first dose of study drug
- •8. Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary
- •disease, severe Parkinson’s disease, active inflammatory bowel disease) or psychiatric
- •9. Active bleeding diatheses
- •10. Participant has received an organ transplant
- •11. Known hepatitis B, hepatitis C, Epstein-Barr virus (EBV) or human immunodeficiency
- •virus infection (HIV).
- •12. Participant is breastfeeding or pregnant
- •13. Receipt of licensed or unlicensed cytotoxic, non-cytotoxic or small molecule therapy for the malignancy within 28 days or 5 half-lives,
- •whichever is shorter, prior to the first dose of IMP at Cycle 0, Day 1
- •14. Receipt of oral corticosteroids (at a dose greater than 10 mg prednisone/day or equivalent) within 14 days prior to the first dose of IMP (except for subjects receiving corticosteroids for adrenal insufficiency) at Cycle 0, Day 1
- •15. Receipt of St John’s Wort within 21 days prior to the first dose of IMP or of another
- •concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer
- •of CYP3A4 enzymes within 14 days prior to the first dose of IMP at Cycle
- •16. Receipt of a blood transfusion (blood or blood products) within 14 days prior to the first
- •dose of IMP at Cycle 0, Day 1
- •17. Impaired hepatic or renal function as demonstrated by any of the following laboratory
- •a. Albumin less than 30 g/L.
- •b. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 times the
- •upper limit of normal (ULN) (greater than 5.0 times ULN for participants with liver metastases).
- •c. Total bilirubin greater than 1.5 times ULN (for participants with gilbert's syndrome, ULN is considered to be 2.9 mg per ml)
- •d. Serum creatinine greater than 1.5 times ULN.
- •18. Liver function deteriorating in a manner that would likely make the participant meet the
- •AST, ALT, or bilirubin levels specified above prior to the first dose of IMP at Cycle 0,
- •19. Other evidence of impaired hepatic synthesis function.
- •20. Inadequate bone marrow reserve or organ function as demonstrated by any of the
- •following laboratory values:
- •a. Absolute neutrophil count (ANC) less than 1.5 times 109/L.
- •b. Platelet count less than 100 times 109/L.
- •c. Haemoglobin less than 90 g/L.
- •21. Any prior history of persistent (greater than 4 weeks) severe pancytopeni
研究者
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