2023-508832-68-00招募中2 期
A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 143
- 试验地点
- 19
- 主要终点
- Dose escalation: Incidences of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), infusion-related AEs, Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 AEs, and AEs related to trial treatment during the trial
研究概览
简要总结
Dose escalation: to establish the maximum tolerated Dose(MTD) and RP2D of tisotumab vedotin in combination in subjects with advanced cervical cancer Dose expansion: Evaluate the antitumor activity of tisotumab vedotin monotherapy and in combination in subjects with cervical cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after SOC treatments or are ineligible or intolerant to SOC for recurrent or stage IVB cervical cancer. (Arms A, B, and C only).
- •Criterion revised per Amendment 6&
- •Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E and H).
- •Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than 2 prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and Arm G only).
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
- •Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration. A WOCBP must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration (all arms).
- •Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).
排除标准
- •Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
- •2- Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
- •3- Has Clinically significant bleeding issues or risks. Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) ( Arm A and bevacizumab-eligible participants in Arm H)
- •4- Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arm A and Bev eligible Arm H only)
- •5- Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arm A and Bev eligible Arm H only)
- •6- Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
- •7-Clinically significant cardiac disease
- •8-Requires anti-coagulation therapy (Arms A and H only
结局指标
主要结局
Dose escalation: Incidences of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), infusion-related AEs, Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 AEs, and AEs related to trial treatment during the trial
Dose escalation: Incidences of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), infusion-related AEs, Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 AEs, and AEs related to trial treatment during the trial
Dose Expansion: ORR per RECIST v1.1
Dose Expansion: ORR per RECIST v1.1
次要结局
- Overall Survival (OS)
- TTR per RECIST v1.1
- PFS per RECIST v1.1
- Objective Response Rate (ORR) per RECIST v1.1 (only dose escalation)
- DOR per RECIST v1.1
- AEs and evaluation of safety laboratory parameters
- PK-concentrations and anti-drug antibodies (ADAs) associated with tisotumab vedotin
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (19)
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