NCT05755113招募中2 期
A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tumour Response
研究概览
简要总结
A Phase IIa open label study evaluating the preliminary efficacy of intratumoural tigilanol tiglate in advanced and/or metastatic soft tissue sarcoma of the extremities and body wall.
详细描述
Primary Objective
- To evaluate tumour ablation in tumours and/or tumour segments following one or more treatments with tigilanol tiglate; and
- To evaluate the effect of tigilanol tiglate on overall disease control (not limited to injected tumours) (Stage 2 only).
Secondary Objective
- To assess the safety and tolerability of intratumoural injections with tigilanol tiglate; and
- To evaluate systemic exposure through pharmacokinetic (PK) assessment after a single intratumoural injection of tigilanol tiglate.
Exploratory Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are willing and able to provide written informed consent for the study prior to any protocol-specific procedures and to comply with all local and study requirements.
- •Are ≥ 18 years of age on the day of providing informed consent.
- •Have advanced and/or metastatic disease of the body wall or extremities that is amenable to intratumoural injection either by palpation or under ultrasound guided injection, that has been histologically or pathologically confirmed as an STS. STS located on the scalp may also be considered for treatment.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Have life expectancy of more than 12 weeks.
- •Have adequate renal and hepatic function as assessed by the Investigator.
- •Female participants who are Women Of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test at Screening (within 14 days of the first study drug administration), must be willing to use a highly effective contraception from date of consent, throughout the study period and up to 30 days after the last study drug administration, and must not be breastfeeding.
- •Male participants with a potentially fertile female partner are eligible if they have had a vasectomy or are willing to use adequate contraception from prior to commencement of study drug administration, throughout the study period and up to 30 days after the last study drug administration, and must not donate sperm throughout the study period and up to 30 days after the last study drug administration.
排除标准
- •Are planning to receive intratumoural treatment or radiotherapy to any of the tumours intended for injection within 28 days prior to Screening, or during treatment with tigilanol tiglate.
- •Have a tumour intended for injection that is immediately adjacent to, or with infiltration into, any major artery or vein (e.g., if the tumour for injection is located adjacent to the jugular vein).
- •Are receiving or have received other investigational agents or have used an investigational device without undergoing a 28-day (or 5 half-lives, whichever is shorter) wash-out period prior to their first treatment with tigilanol tiglate. These patients must have recovered from all AEs due to previous investigational therapies to ≤ Grade 1 at baseline.
- •Are receiving or have received systemic anticancer therapy, without undergoing a 28-day (or 5 half-lives, whichever is shorter) wash-out period prior to their first treatment with tigilanol tiglate. These patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 at baseline. Patients with ≤ Grade 2 neuropathy may be eligible following discussion with Sponsor Medical Monitor.
- •Have had major surgery within 28 days of their first treatment with tigilanol tiglate or anticipate the need for major surgery during the study period. Minor surgical procedures are permitted, but with sufficient time for wound healing.
- •Have known, active brain metastases and/or carcinomatous meningitis. Participants who have previously treated brain metastases and are neurologically stable can be included.
- •Have any bleeding diathesis or coagulopathy that would make intratumoural injection or biopsy unsafe, or if they are on therapeutic warfarin therapy.
- •Have a history of allergic reactions or severe hypersensitivity (Grade ≥ 3) attributed to tigilanol tiglate or compounds of similar chemical or biologic composition to tigilanol tiglate, any of its excipients or other agents used in the study.
- •In the opinion of the treating Investigator, they are not an appropriate candidate for the study for any reason (e.g., they have known psychiatric or substance abuse disorder that would interfere with their ability to cooperate with the requirements of the study.
研究组 & 干预措施
Single Arm, Open Label
Experimental
Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area [BSA]) per treatment.
干预措施: Tigilanol Tiglate (Drug)
结局指标
主要结局
Tumour Response
时间窗: 6 months
Proportion of participants who have achieved partial or complete ablation of treated tumour(s) and/or tumour segment(s) following injection(s) with tigilanol tiglate.
ORR as determined by RECIST
时间窗: 3 and 6 months post initial treatment (Stage 2 only)
Objective Response Rate (ORR) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST) V1.1
次要结局
- Systemic Exposure(Up to 24 hours after the first dose)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck CancerHead and Neck CancerNCT05608876QBiotics Group Limited15
招募中
1 期
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid TumorsSolid TumorHNSCCMelanomaNSCLCSarcomaSquamous Cell CarcinomaNCT04370587ImmVira Pharma Co. Ltd30
已完成
2 期
A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid TumorsPD-L1-selected Solid TumorsNCT05661578Hoffmann-La Roche64
招募中
2 期
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and FirmonertinibNon-Small Cell Lung Cancer With EGFR MutationNCT06668103Abbisko Therapeutics Co, Ltd54
进行中（未招募）
1 期
Study of BO-112 with pembrolizumab for colorectal or gastric /gastro-oesophageal junction cancer with liver metastasisColorectal cancer or gastric/gastro-oesophageal junction cancer with liver metastasisMedDRA version: 21.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004624-38-ESBioncotech Therapeutics, S.69
相关资讯
QBiotics' Tigilanol Tiglate Achieves 80% Response Rate in Soft Tissue Sarcoma Phase IIa Trial- QBiotics reported an 80% objective response rate in Stage 1 of its Phase IIa trial evaluating tigilanol tiglate in 10 patients with advanced soft tissue sarcoma.
- Of 27 injected tumors, 81% showed complete or partial ablation, with 14 tumors achieving complete destruction and none recurring at 6-month follow-up.
- The small molecule drug was well tolerated with mostly localized adverse events, supporting progression to Stage 2 expansion at Memorial Sloan Kettering Cancer Center.
- Three patients demonstrated enhanced responses to subsequent systemic therapies, suggesting potential synergistic effects with standard treatments.last yearFDA Grants Orphan Drug Designation to Tigilanol Tiglate for Soft Tissue Sarcoma Treatment- The FDA has awarded orphan drug designation to tigilanol tiglate (Stelfonta), an intratumoral injection, for treating soft tissue sarcoma, a rare cancer affecting both adults and children.
- The designation provides QBiotics with important regulatory incentives including tax credits, user fee exemptions, and potential seven years of market exclusivity following approval.
- Tigilanol tiglate is currently being evaluated in a phase 2 trial at Memorial Sloan Kettering Cancer Center, with preliminary phase 1 data showing responses in 6 of 22 patients.
- Soft tissue sarcomas comprise more than 80 subtypes with unfavorable prognosis in advanced stages, highlighting the urgent need for new treatment options in this rare disease area.2 years ago