A Single Ascending Dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetic Profile of MSP008-22 in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is the 'first-in-human' clinical trial of the Investigational Medicinal Product (IMP), Tablet formulation for Oral dosing of MSP008-22, a molecule (new chemical entity) with anticancer properties.
详细描述
This Single Ascending Dose (SAD) clinical trial is designed to evaluate the safety and tolerability of single oral ascending doses of the IMP in patients with Stage IV of advanced solid tumours including but not limited to Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).
The trial will also assess the pharmacokinetic (PK) profile of MSP008-22 in humans.
The safety, tolerability and PK data from this trial will determine the safety of MSP008-22 for dosing in humans in further clinical trials.
As MSP008-22 has shown efficacy in in vitro studies against various cancer cell lines and in prostate and breast cancer cell lines in xenograft studies, the first in human trial of MSP008-22 is planned in patients of 'Stage-IV of Advanced Solid Tumours (Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer and other advanced solid tumors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
It is an open-label clinical trial with a single treatment arm.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, willing to provide written informed consent and willing to comply to trial requirements, in age range of 18-60 years (both inclusive), with stage IV - metastatic or unresectable Solid tumours (Breast cancer including TNBC, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).
- •Adequate bone marrow function and hepatic & Renal function
- •Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) ≥ 70
- •Adequate laboratory parameters for Haemoglobin levels, Absolute Neutrophil Count (ANC), Platelets, AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), Total bilirubin ≤ 1.5 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN), and Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min
- •If male, must agree to use contraception and refrain from donating sperm during the treatment period and for ≥120 days after last dose of trial treatment.
- •If female, is not pregnant or breastfeeding, and agrees to use contraception during the treatment period and for ≥120 days after last dose of trial treatment.
排除标准
- •Patients who have been treated with most recent radiotherapy, immunotherapy, chemotherapy or investigational drugs within ≤10 days or 5 half-lives (whichever is shorter) from enrolment (screening), and/or who have any unresolved NCI Common Terminology Criteria of Adverse Events (CTCAE) v5.0 > Grade 1 treatment-related side effect, with the exceptions of alopecia
- •Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days.
- •Primary immunodeficiency affecting cellular immunity and active autoimmune disease with the exception of Type I Diabetes Mellitus, hypothyroidism requiring hormone replacement only, an autoimmune dermatologic condition that is managed without systemic therapy, or autoimmune arthritis that is managed without systemic therapy or documented history of autoimmune syndrome or disease.
- •Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication.
- •Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
研究组 & 干预措施
MSP008-22 treatment arm
Oral Escalating doses of MSP008-22- total five doses, each in form of a single dose oral formulation/tablet.
Each trial participant will receive only one single oral dose of 05 identified dose levels of MSP008-22. Intra-patient dose escalation will not be carried out
干预措施: MSP008-22 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 10 days post dose
to assess Tolerability of MSP008-22 in Human
Incidence of dose-limiting toxicities (DLTs)
时间窗: 10 days post-dose
to assess Safety of MSP008-22 in Human
Incidence of Treatment Emergent adverse events (TEAE); % of patients who experience at least 1 Treatment Emergent Adverse Event (TEAE); % of patients who discontinue due to TEAE(s).
时间窗: 30 days post-dose
to assess Safety of MSP008-22 in Human
次要结局
- CLr(72 hours post dose)
- Vz/F(72 hours post dose)
- Plasma Cmax(72 hours post dose)
- Plasma AUClast(72 hours post dose)
- Plasma AUCinfinity(72 hours post dose)
- plasma tmax(72 hours post dose)
- Plasma t1/2(72 hours post dose)
- CL/F(72 hours post dose)
- Ae(72 hours post dose)
- Ae %dose(72 hours post dose)