NCT06462183招募中1 期
A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 10
- 主要终点
- Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
详细描述
This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an oral, small molecule MYB inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed ACC or CRC
- •Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- •Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry
- •Patients with CRC must have locally R/R advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.
- •Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- •Resolved acute effects of any prior therapy to baseline
排除标准
- •Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
- •Chemotherapy within 14 days prior to Cycle 1 Day 1
- •Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1
- •Radiation therapy within 21 days prior to Cycle 1 Day 1
- •Investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1
- •Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment
- •Active known second malignancy
- •Clinically significant cardiac disease
- •Infection with human immunodeficiency virus (HIV)-1 or HIV-2 unless it's well-controlled HIV (eg, cluster of differentiation 4 [CD4] > 350/mm3 and undetectable viral load)
- •Current active liver disease including hepatitis A (hepatitis A [HepA] virus immunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus [HBV] surface antigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV RNA)
- •Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
- •Uncontrolled diabetes
- •Treatment with a long-acting hematopoietic growth factor within 14 days before Cycle 1 Day 1 or a short-acting hematopoietic growth factor within 7 days before Cycle 1 Day 1
- •Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days before Cycle 1 Day 1
- •Patients with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroid throughout this indication for at least 4 weeks before starting treatment in this study
- •History of solid organ transplantation
- •Coronavirus disease 2019 (COVID-19) vaccination within 14 days prior to first dose of study drug
- •Prior treatment with a MYB inhibitor
研究组 & 干预措施
Dose escalation
Experimental
RGT-61159 in escalating doses
干预措施: RGT-61159 (Drug)
Dose expansion Cohort A
Experimental
Dose optimization; RGT-61159, 2 doses, randomized allocation
干预措施: RGT-61159 (Drug)
Dose expansion Cohort B
Experimental
Simon's 2 stage, RGT-61150 at optimized dose from Part A
干预措施: RGT-61159 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D)
时间窗: Assessed at the end of Cycle 1 for each subject (each cycle 21 days)
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration
时间窗: 21 days
Number and type of adverse events
时间窗: Through study completion, estimated as 30 days after last dose of study drug
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
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相关资讯
Rgenta Therapeutics to Present Phase 1 Clinical Data on RNA-Targeting Cancer Drug RGT-61159 at ASCO 2026- Rgenta Therapeutics will present clinical data from its ongoing Phase 1a/b study of RGT-61159, an oral MYB splicing modulator, at the 2026 ASCO Annual Meeting in Chicago.
- RGT-61159 is designed to specifically modulate splicing of the transcription factor MYB, resulting in inhibition of the oncogenic MYB protein in cancer cells that overexpress it.
- The multi-center, open-label Phase 1a/b clinical trial is evaluating RGT-61159 in patients with advanced relapsed or refractory adenoid cystic carcinoma or colorectal cancer.
- MYB acts as a master regulator of cell proliferation and has demonstrated aberrant expression in multiple cancer types including ACC, AML, T-ALL, CRC, SCLC and breast cancer.4 months agoRgenta Therapeutics Doses First Patients in Phase 1a/b Trial of MYB-Targeting RGT-61159 for Advanced Cancers• Rgenta Therapeutics has initiated a Phase 1a/b clinical trial of RGT-61159, an oral small molecule targeting MYB, in patients with advanced adenoid cystic carcinoma (ACC) and colorectal cancer (CRC).
• The trial is designed to evaluate the safety, tolerability, pharmacokinetics, target engagement, and preliminary efficacy of RGT-61159 in patients with relapsed or refractory ACC or CRC.
• RGT-61159 modulates MYB splicing, inhibiting oncogenic MYB protein production, which is overexpressed in ACC and CRC, offering a potential new treatment approach.
• The study addresses a significant unmet need, as current systemic treatment options for ACC are limited, and patients with relapsed or refractory CRC have poor prognoses.last year