A Phase 1 Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Advanced or Recurrent Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of dose limiting Toxicities
研究概览
简要总结
Activity of COTI-2 has been demonstrated in various cancer tumor models. With its p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of patients with gynecologic malignancies or head and neck squamous cell carcinoma (HNSCC) as well as a variety of other tumor types.
This study is designed primarily to assess the safety and tolerability of COTI-2 monotherapy or combination therapy in patients with advanced and recurrent malignancies to establish a recommended Phase 2 dose (RP2D) for future studies.
Patients are currently being recruited for Part 3 of the study.
Critical Outcome Technologies Inc. has been renamed to Cotinga Pharmaceuticals.
详细描述
This is a three-part, multi-center, open-label, Phase 1, first-in-patient study of COTI-2 in patients with recurrent ovarian, fallopian tube, primary peritoneal, endometrial, or cervical cancer (collectively gynecological malignancies), and in patients with head and neck squamous cell carcinoma (HNSCC), colorectal, lung, or pancreatic cancer. Other tumor types may be allowed with Sponsor approval.
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week.
Part 1 of the study will be dose finding in patients with gynecological malignancies using a 3 + 3 design to establish the MTD (maximum tolerated dose) over 6 planned cohorts.
Part 2 of the study will be dose finding in patients with HNSCC using a 3 + 3 design to establish the MTD over 6 planned cohorts.
Part 3 of the study will be dose finding for COTI-2 in combination with cisplatin in patients with gynecological malignancies, HNSCC, colorectal, lung, pancreatic cancer, or other tumor types with Sponsor approval.
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
- 未提供
排除标准
- •Pregnant or lactating.
- •History of other invasive malignancies, with the exception of non-melanoma skin cancer or successfully treated in situ carcinoma, if there is evidence of the malignancy being present within the last 3 years.
- •Inability to tolerate oral medications.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- •History of clinically significant or uncontrolled cardiac disease including but not limited to:
- •Myocardial infarction,
- •Angina pectoris,
- •Congestive heart failure of New York Heart Association (NYHA) Grade >2,
- •Ventricular arrhythmias requiring continuous therapy, or
- •Supraventricular arrhythmias including atrial fibrillation, which are uncontrolled.
- •Major surgery, excluding skin biopsies and procedures for insertion of central venous access devices, within 28 days prior to the start of COTI-
- •Active, uncontrolled bacterial, viral, fungal, or other opportunistic infection requiring systemic therapy.
- •The presence of or imminent occurrence of airway obstruction, unless tracheostomy in place.
- •HPV-positive status ( In HNSCC patients only)
研究组 & 干预措施
COTI2
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week; 1 cycle will be defined as 4 weeks of treatment as described (5 days on, 2 days off per week). Participants will remain on treatment until they experience a lack of benefit.
干预措施: COTI2 (Drug)
COTI2 + cisplatin
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week; 1 cycle will be defined as 3 weeks of treatment as described (5 days on, 2 days off per week). Cisplatin 60 mg/m2 IV will be administered on Day 1 of each 3 week cycle. Participants will remain on treatment until they experience a lack of benefit.
干预措施: COTI2 (Drug)
COTI2 + cisplatin
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week; 1 cycle will be defined as 3 weeks of treatment as described (5 days on, 2 days off per week). Cisplatin 60 mg/m2 IV will be administered on Day 1 of each 3 week cycle. Participants will remain on treatment until they experience a lack of benefit.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of dose limiting Toxicities
时间窗: 12 months
Used to measure safety and tolerability of COTI2
Tmax
时间窗: 6 months
To determine maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
次要结局
- Progression Free survival(12 months)
- Clinical response(6 Months)