Anetumab ravtansine rollover study

An open-label, multicenter rollover study to provide continued treatment with anetumab ravtansine for participants with solid tumors who were enrolled in previous Bayer-sponsored studies.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000061-20-FR

Enrollment

Registered

2019-02-04

Start date

2019-05-23

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

MedDRA version: 20.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 100

Interventions

Product Name: Anetumab ravtansine Product Code: BAY 94-93-9343 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: ANETUMAB RAVTANSINE Current Sponsor code: BAY 94-9343 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study at the time of its planned study closure. For on-treatment participants: participant is eligible to receive the next dose of study intervention per the parent study protocol. For on-treatment participants: any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: For on-treatment participants: a positive serum pregnancy test. For on-treatment participants: use of one or more of the prohibited medications listed in the respective parent study protocol. Participants who are receiving SOC agent(s) but not anetumab ravtansine in the parent study, and are able to receive SOC agent outside of the clinical study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety;Secondary Objective: Survival;Primary end point(s): Incidence of TEAEs Incidence of TESAEs Incidence of Drug-related TEAEs and TESAEs;Timepoint(s) of evaluation of this end point: End of study	—

Secondary

Measure	Time frame
Secondary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: End of study	—

Countries

Belgium, France, Italy, Poland, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026