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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508832-68-00

Acronym

GCT1015-05

Enrollment

143

Registered

2024-04-16

Start date

2019-03-28

Completion date

Unknown

Last updated

2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or stage IVB cervical cancer

Brief summary

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

Detailed description

AEs and evaluation of safety laboratory parameters, Objective Response Rate (ORR) per RECIST v1.1 (only dose escalation), DOR per RECIST v1.1, TTR per RECIST v1.1, PFS per RECIST v1.1, Overall Survival (OS), PK-concentrations and anti-drug antibodies (ADAs) associated with tisotumab vedotin

Interventions

DRUGCARBOPLATIN

DRUGPEMBROLIZUMAB

DRUGBEVACIZUMAB

DRUGHuMax-TF-ADC

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
AEs and evaluation of safety laboratory parameters, Objective Response Rate (ORR) per RECIST v1.1 (only dose escalation), DOR per RECIST v1.1, TTR per RECIST v1.1, PFS per RECIST v1.1, Overall Survival (OS), PK-concentrations and anti-drug antibodies (ADAs) associated with tisotumab vedotin	—

Countries

Belgium, Czechia, Ireland, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026