2024-516722-59-00招募中2 期
A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants with Select Epithelial Solid Tumours Under Multiple Sub-protocols (ATTEST)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments
研究概览
简要总结
• To evaluate the safety and tolerability of ATTR-01 in participants with select solid epithelial tumours (this is a secondary objective in SP B) • Where applicable for sub-protocols incorporating dose escalation: To determine the optimal dose of ATTR-01 for further development of ATTR-01 in participants with select epithelial solid tumours • To evaluate the anti-tumour activity of ATTR-01 in participants with select solid epithelial tumours (does not apply to SP A)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Consenting male and female adults (≥ 18 years of age) with select solid epithelial tumour indications known to have high frequency (≥75%) of αvβ6 integrin receptor expression as detailed in the applicable SP.
- •Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies.
- •Applicable to SP-A only: Histologically proven cancer, stage IV, epithelial cancer of an indication as listed in Table 4 in Sub-protocol A.
- •Applicable to SP-A only: Only participants with tumours accessible for biopsy will be considered eligible to enrol.
- •Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible.
- •Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).
- •Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.
- •Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 (V1.1).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Minimum life expectancy anticipated to be greater than three months.
- •Willing to undertake appropriate measures of hygiene and protection, including regular hand washing, not sharing personal items (e.g. sharing of towels and cutlery), and avoiding close physical contact with the following groups for ten days after the last administration: a. Women who are pregnant or lactating b. Children under one year old c. Nursing home residents d. Those who have significant immunodeficiency because of underlying illness (e.g. human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication (e.g. systemic corticosteroids).
- •Adequate organ function.
排除标准
- •Participants with clinically significant fibrotic disease will be excluded. This includes participants with autoimmune diseases such as systemic lupus, rheumatoid arthritis. Participants with idiopathic and occupation-related pulmonary fibrosis will also be excluded.
- •Any active autoimmune disease or chronic inflammatory conditions (apart from: Type 1 diabetes, hypothyroidism requiring thyroxine replacement, chronic skin conditions that do not require treatment or only topical steroids, coeliac disease on dietary control only and diverticulosis).
- •Known prior history of intolerance to anti-PD-1 and/or anti-PD-L1 immunotherapy due to toxicity.
- •Tumour location/extent considered by the investigator to present a significant risk if tumour flare were to occur (e.g. an initial increase in tumour size that may lead to intestinal, airway or ureter obstruction, or penetrating tumour infiltration of major blood vessels, or other hollow organs potentially at risk of perforation).
- •Participants with radiological lymphangitis carcinomatosa.
- •Open/major surgical procedure within eight weeks or minor (day case) surgery within four weeks, prior to administration of the IMP, or any prior surgery without evidence of adequate wound healing.
- •Pre-existing known acute or chronic viral disease (e.g. HIV/Hepatitis B/Hepatitis C).
- •Participants with known prior primary or acquired immune deficiency. Prior splenectomy cases are eligible provided that participants have received post-splenectomy vaccines (pneumococcal, meningococcal and haemophilus influenzae) in keeping with their hospital practice and are either on prophylactic antibiotics or have completed a two-year course.
- •Diagnosed and active bacterial, fungal or viral infections within four weeks of D1 of the IMP administration.
- •Any pre-existing condition requiring use of systemic immunosuppressants.
结局指标
主要结局
Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments
Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments
Objective Response Rate (ORR) from first scan onwards, per RECIST V1.1
Objective Response Rate (ORR) from first scan onwards, per RECIST V1.1
Duration of Response (DoR)
Duration of Response (DoR)
次要结局
- ATTR-01 viral persistence/blood concentrations
- Per RECIST V1.1 from first scan onwards: • Disease Control Rate (DCR)
- Per RECIST V1.1 from first scan onwards: • Time To Response (TTR)
- Per RECIST V1.1 from first scan onwards: • Progression Free Survival (PFS)
- Per RECIST V1.1 from first scan onwards: • Overall Survival (OS)
- Per RECIST V1.1 from first scan onwards: • Maximum reduction in tumour size
- SP A only: • ORR from first scan onwards, per RECIST V1.1
- SP A only: • Duration of Response (DoR)
- ATTR-01 immunogenicity/anti-ATTR-01 antibodies
研究者
Hardev Pandha
Scientific
Accession Therapeutics Limited
研究点 (3)
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