A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

TORL Biotherapeutics, LLC23 个研究点分布在 3 个国家目标入组 90 人2021年11月17日

适应症Advanced Solid Tumor Ovarian Cancer Endometrial Cancer NSCLC

干预措施TORL-1-23

概览

阶段: 1 期
干预措施: TORL-1-23
疾病 / 适应症: Advanced Solid Tumor
发起方: TORL Biotherapeutics, LLC
入组人数: 90
试验地点: 23
主要终点: Recommended Phase 2 Dose (RP2D)
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

注册库

clinicaltrials.gov

开始日期

2021年11月17日

结束日期

2026年11月15日

最后更新

2个月前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

TORL Biotherapeutics, LLC

责任方

Sponsor

入排标准

入选标准

•Advanced solid tumor
•Measurable disease, per RECIST v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•Adequate organ function

排除标准

•Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
•Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23
•Progressive or symptomatic brain metastases
•Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
•History of significant cardiac disease
•History of myelodysplastic syndrome (MDS) or AML
•History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
•If female, is pregnant or breastfeeding

研究组 & 干预措施

Monotherapy Dose Finding - Part 1

TORL-1-23

干预措施: TORL-1-23

Expansion as Monotherapy - Part 2

TORL-1-23

干预措施: TORL-1-23

结局指标

主要结局

Recommended Phase 2 Dose (RP2D)

时间窗: up to 2 years

Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Maximum Tolerated Dose (MTD)

时间窗: 28 Days

Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

Incidence and severity of adverse events and serious adverse events

时间窗: up to 2 years

Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

次要结局

Duration of Response (DOR)(up to 2 years)
Objective Response Rate (ORR)(up to 2 years)
1 Year Overall Survival (1YOS)(1 year)
2 Year Overall Survival (2YOS)(2 years)
Maximum Serum Concentration of TORL-1-23 (Cmax)(21 days)
Time to Response (TTR)(up to 2 years)
Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
Minimum Serum Concentration of TORL-1-23 (Cmin)(21 days)
Apparent volume of distribution during the terminal phase (Vz) of TORL-1-23(63 days)
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23(21 days)
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23(63 days)
Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss)(63 days)
Progression Free Survival (PFS)(up to 2 years)
Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss)(63 days)
Terminal Half-life (t1/2) of Serum TORL-1-23(63 days)
Time of Maximum Serum Concentration of TORL-1-23 (Tmax)(21 days)
Time of Minimum Serum Concentration of TORL-1-23 (Tmin)(21 days)
Time of Minimum Serum Concentration of TORL-1-23 at Steady State (Tmin,ss)(63 days)
Clearance (CL) of TORL-1-23(63 days)
Accumulation ratio (Rac) of TORL-1-23(63 days)