EUCTR2017-004758-40-NL进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
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
- •Criterion revised per Amendment 7
- •- 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.
- •- 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •- Has clinically relevant bilateral hydronephrosis which cannot be
- •alleviated by ureteral stents or percutaneous drainage. (All Arms)
- •- 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
- •- Criterion revised per Amendment 6
- •- Criterion revised per Amendment 7
- •- Has clinically significant bleeding issues or risks
- •- Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arms A and H)
- •- Recent (within 4 weeks of first dose of trial treatment) clinically
- •significant gastrointestinal or vaginal bleeding requiring PRBC
- •transfusion (Arm A and bevacizumab-eligible subjects in Arm H)
- •- Recent (within 4 weeks of first dose of trial treatment) evidence of
- •wound healing complications that require medical intervention (Arm A and bevacizumab-eligible subjects in Arm H)
- •Criterion revised per Amendment 6
- •- Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms)
研究者
相似试验
招募中
不适用
A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TFADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical CancerCervical Carconoma10038594Cervical CancerNL-OMON52957Genmab10
进行中（未招募）
1 期
Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) Monotherapy and in combination in recurrent or Stage IVB cervical cancerEUCTR2017-004758-40-ITGENMAB A/S140
进行中（未招募）
1 期
Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) monotherapy in combination in recurrent or Stage IVB cervical cancerrecurrent or stage IVB cervical cancerMedDRA version: 21.1 Level: PT Classification code 10008342 Term: Cervix carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004758-40-GBGenmab A/S140
招募中
1 期
Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) monotherapy and in combination in recurrent or Stage IVB cervical cancerRecurrent or stage IVB cervical cancerMedDRA version: 21.1Level: PTClassification code: 10008342Term: Cervix carcinoma Class: 100000004864CTIS2023-508832-68-00Genmab A/S143
进行中（未招募）
1 期
Efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) in combination in recurrent or Stage IVB cervical cancerrecurrent or stage IVB cervical cancerMedDRA version: 21.1Level: PTClassification code 10008342Term: Cervix carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004758-40-CZGenmab A/S140