NCT07109726招募中1 期
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Terremoto Biosciences Inc.27 个研究点 分布在 4 个国家目标入组 205 人开始时间: 2025年9月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 205
- 试验地点
- 27
- 主要终点
- Objective Response Rate as assessed by RECIST v1.1
研究概览
简要总结
This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.
详细描述
This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Metastatic or locally advanced, unresectable disease
- •No available treatment with curative intent
- •Presence of lesions to be evaluated per RECIST v1.1:
- •a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
- •Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test
- •Key Inclusion Criteria for TER-2013 monotherapy arms:
- •Histologically confirmed diagnosis of:
- •a. [For TER-2013 dose escalation]: solid tumor malignancy b. [For TER-2013 cohort expansion]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma
- •Prior therapy:
- •[For TER-2013 dose escalation]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused
- •[For TER-2013 cohort expansion]: No more than 3 prior lines of treatment in the advanced setting
- •Key Inclusion Criteria for TER-2013 and fulvestrant combination arms
- •Histologically confirmed diagnosis of:
- •a. [For TER-2013 + fulvestrant dose escalation]: HR+/HER2- advanced unresectable or metastatic breast cancer b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
- •Prior Therapy:
- •a. [For TER-2013 + fulvestrant dose escalation]: Received treatment with an AI containing regimen (single agent or in combination) b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
排除标准
- •Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
- •Clinically significant abnormalities of glucose metabolism
- •Active brain metastases or carcinomatous meningitis.
- •History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
- •Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013
- •Prior therapy:
- •[For TER-2013 monotherapy escalation]: AKT inhibitor
- •[For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor
- •[For TER-2013 + fulvestrant combination expansion]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.
- •Other protocol-defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
Monotherapy Dose Escalation
Experimental
干预措施: TER-2013 (Drug)
Monotherapy Dose Expansion
Experimental
干预措施: TER-2013 (Drug)
Combination Therapy Dose Expansion
Experimental
Dose Expansion of TER-2013 with recommended dose of fulvestrant
干预措施: TER-2013 (Drug)
Combination Therapy Dose Expansion
Experimental
Dose Expansion of TER-2013 with recommended dose of fulvestrant
干预措施: Fulvestrant injection (Drug)
Combination Therapy Dose Escalation
Experimental
Dose Escalation of TER-2013 with recommended dose of fulvestrant
干预措施: Fulvestrant injection (Drug)
Combination Therapy Dose Escalation
Experimental
Dose Escalation of TER-2013 with recommended dose of fulvestrant
干预措施: TER-2013 (Drug)
结局指标
主要结局
Objective Response Rate as assessed by RECIST v1.1
时间窗: Up to 2 years
Number of Patients who Experience Dose-Limiting Toxicity
时间窗: 28 Days
Number of patients who experience a treatment-related adverse event
时间窗: Up to 2 years
Duration of Response as assessed by RECIST v1.1
时间窗: Up to 2 years
次要结局
- Maximum concentration (Cmax) of TER-2013(Up to 2 years)
- Time to maximum concentration (Tmax) of TER-2013(Up to 2 years)
- Terminal elimination half-life (T1/2) of TER-2013(Up to 2 years)
- Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013(Up to 2 years)
- Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40(Up to 2 years)
- Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT(Up to 2 years)
研究者
研究点 (27)
Loading locations...
相似试验
招募中
1 期
A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and PrednisoneProstate CancerNCT06689163Jiangsu HengRui Medicine Co., Ltd.66
进行中（未招募）
1 期
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene AlterationsLocally Advanced Urothelial CarcinomaMetastatic Urothelial CarcinomaSolid TumorUrothelial CarcinomaSolid Tumor, AdultNon-muscle-invasive Bladder CancerFGFR3 Gene MutationFGFR3 Gene AlterationAdvanced Solid TumorAdvanced Urothelial CarcinomaUrinary Tract CancerUrinary Tract TumorUrinary Tract CarcinomaBladder CancerNCT05544552Tyra Biosciences, Inc310
已完成
1 期
A Phase 1/2 Study to Evaluate MEDI4736Advanced Solid TumorsNCT01693562MedImmune LLC1,022
终止
1 期
Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal MetastasisPeritoneal MetastasesNCT05431907Enlivex Therapeutics RDO Ltd.9
撤回
1 期
Study of Selinexor (KPT- 330), Lenalidomide, & Dexamethasone in Relapsed/Refractory Multiple Myeloma PatientsMultiple MyelomaNCT02389543Karyopharm Therapeutics Inc