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

Recruiting

• Conditions: Cervical Cancer; Cervical Carconoma; 10038594

• Registration Number: NL-OMON52957
• Lead Sponsor: Genmab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- 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
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).

Exclusion Criteria

- 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dose escalation: Incidences of DLTs, AEs, SAEs, infusion-related AEs, CTCAE<br /><br>grade >= 3 AEs, and AEs related to trial treatment during the trial Dose<br /><br>expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in<br /><br>Solid Tumors (RECIST) v 1.1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Adverse events (AEs) and evaluation of safety laboratory parameters.<br /><br>• Objective Response Rate (ORR) per RECIST v1.1 (only dose escalation)<br /><br>• Duration of Response (DOR) per RECIST v1.1.<br /><br>• Time to Response (TTR) per RECIST v1.1.<br /><br>• Progression free survival (PFS) per RECIST v1.1.<br /><br>• Overall Survival (OS)<br /><br>• PK-concentrations and anti-drug antibodies (ADA) associated with tisotumab<br /><br>vedotin in combination.</p><br>