NCT06462183进行中（未招募）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
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 19
- 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
- •Patients with ACC must have documented evidence of intact MYB pseudoexon positive criteria or be MYB wild type and patients with CRC must have amplification of MYB as determined by designated assay
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 expansion RGT-61159 monotherapy intermittant dosing
Experimental
干预措施: RGT-61159 (Drug)
Dose escalation RGT-61159 continuous dosing + lenvatanib
Experimental
RGT-61159 in escalating doses + lenvatanib
干预措施: RGT-61159 (Drug)
Dose escalation RGT-61159 continuous dosing + lenvatanib
Experimental
RGT-61159 in escalating doses + lenvatanib
干预措施: lenvatinib (Drug)
Dose expansion RGT-61159 continuous dosing + lenvatinib
Experimental
干预措施: RGT-61159 (Drug)
Dose escalation RGT-61159 intermittent dosing + lenvatinib
Experimental
干预措施: lenvatinib (Drug)
Dose escalation RGT-61159 intermittent dosing + lenvatinib
Experimental
干预措施: RGT-61159 (Drug)
Dose expansion Cohort A monotherapy continuous dosing
Experimental
Dose optimization; RGT-61159 monotherapy, 2 doses, randomized allocation
干预措施: RGT-61159 (Drug)
Dose escalation monotherapy continuous dosing
Experimental
RGT-61159 monotherapy in escalating doses
干预措施: RGT-61159 (Drug)
Dose expansion RGT-61159 continuous dosing + lenvatinib
Experimental
干预措施: lenvatinib (Drug)
Dose expansion Cohort B monotherapy continuous dosing
Experimental
Simon's 2 stage, RGT-61150 monotherapy at optimized dose from Part A
干预措施: RGT-61159 (Drug)
Dose expansion RGT-61159 intermittent dosing + lenvatinib
Experimental
干预措施: lenvatinib (Drug)
Dose expansion RGT-61159 intermittent dosing + lenvatinib
Experimental
干预措施: RGT-61159 (Drug)
Dose escalation RGT-61159 monotherapy intermittent dosing
Experimental
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 (19)
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