NL-OMON52957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 Cancer - GCT1015-05
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Genmab
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and
- •progressed on or after standard of care treatments or are ineligible or
- •intolerant to standard of care for recurrent or stage IVB cervical cancer.
- •(Arms A, B and C only).
- •- 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 only).
- •- Must have squamous, adenosquamous, or adenocarcinoma of the cervix and
- •progressed on or after at least one but no more than two prior systemic
- •therapies for recurrent or stage IVB cervical cancer (Arm F and G only).
- •- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •- 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)
- •- 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)
- •- Has clinically significant bleeding issues or risks (All arms)
- •- Prior history (within 3 months) or current evidence of hemoptysis (1/2
- •teaspoon or more) (Arm A only)
- •- Recent (within 4 weeks of first dose of trial treatment) clinically
- •significant gastrointestinal or vaginal bleeding requiring PRBC transfusion
- •(Arm A only)
- •- Recent (within 4 weeks of first dose of trial treatment) evidence of wound
- •healing complications that require medical intervention (Arm A only)
- •- Has active ocular surface disease at baseline. Subjects with prior history of
- •cicatricial conjunctivitis are ineligible (All Arms).
研究者
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