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NCT03926143

A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies

Terminated Phase 2 Results posted Last updated 4 August 2023
What this trial tests

Phase 2 trial testing BAY94-9343 (Anetumab ravtansine) in Solid Tumors in 9 participants. Terminated before completion.

Timeline
3 June 2019
Primary endpoint
18 May 2022
18 May 2022

Quick facts

Lead sponsorBayer
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date3 June 2019
Primary completion18 May 2022
Estimated completion18 May 2022
Sites7 locations across France, Poland, United States, Italy

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs Primary · Approximately 3 years (from first study treatment until safety follow-up)

Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.

Any TEAE
GroupValue95% CI
Anetumab Ravtansine9
Serious TEAE
GroupValue95% CI
Anetumab Ravtansine2
Any study drug-related TEAE
GroupValue95% CI
Anetumab Ravtansine8
Any study drug-related Serious TEAE
GroupValue95% CI
Anetumab Ravtansine0
Overall Survival Secondary · Approximately 3 years (from first study treatment until safety follow-up)

Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%).

25th percentile
GroupValue95% CI
Anetumab Ravtansine17.66.9 – 34.1
Median
GroupValue95% CI
Anetumab Ravtansine34.16.9 – NA
75th percentile
GroupValue95% CI
Anetumab RavtansineNA28.5 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anetumab Ravtansine
Serious: 2/9 (22%)
Deaths: 5/9

Serious adverse events (4 terms)

ReactionSystemAnetumab Ravtansine
Restrictive cardiomyopathyCardiac disorders
Oedema peripheralGeneral disorders
UrosepsisInfections and infestations
DyspnoeaRespiratory, thoracic and mediastinal disorders
Other adverse events (59 terms — click to expand)

ReactionSystemAnetumab Ravtansine
AnaemiaBlood and lymphatic system disorders
Corneal epithelial microcystsEye disorders
AstheniaGeneral disorders
Oedema peripheralGeneral disorders
Amylase increasedInvestigations
Lipase increasedInvestigations
Blood alkaline phosphatase increasedInvestigations
HyperglycaemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Peripheral motor neuropathyNervous system disorders
GynaecomastiaReproductive system and breast disorders
LeukopeniaBlood and lymphatic system disorders
LymphopeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
Pericardial effusionCardiac disorders
Restrictive cardiomyopathyCardiac disorders
Sinus tachycardiaCardiac disorders
HyperthyroidismEndocrine disorders
CataractEye disorders
KeratitisEye disorders
Vision blurredEye disorders
Corneal disorderEye disorders
Abdominal discomfortGastrointestinal disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
NauseaGastrointestinal disorders
ToothacheGastrointestinal disorders
Chest painGeneral disorders
FatigueGeneral disorders
ConjunctivitisInfections and infestations
SinusitisInfections and infestations
Skin infectionInfections and infestations
Corneal abrasionInjury, poisoning and procedural complications
Foot fractureInjury, poisoning and procedural complications
Activated partial thromboplastin time prolongedInvestigations
Aspartate aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
Blood creatinine increasedInvestigations

Most-reported serious reactions: Restrictive cardiomyopathy, Oedema peripheral, Urosepsis, Dyspnoea.

Data from ClinicalTrials.gov NCT03926143 adverse events section.

Sponsor's own description

The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting cancer with antibody-drug conjugates: Promises and challenges.
    Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
  2. Recent advances of antibody drug conjugates for clinical applications.
    Zhao P, Zhang Y, Li W, Jeanty C, et al · · 2020 · cited 122× · PMID 33088681 · DOI 10.1016/j.apsb.2020.04.012
  3. Bispecific Antibodies and Antibody-Drug Conjugates for Cancer Therapy: Technological Considerations.
    Shim H. · · 2020 · cited 95× · PMID 32111076 · DOI 10.3390/biom10030360
  4. Emerging Treatments for Malignant Pleural Mesothelioma: Where Are We Heading?
    Cantini L, Hassan R, Sterman DH, Sterman DH, et al · · 2020 · cited 47× · PMID 32226777 · DOI 10.3389/fonc.2020.00343
  5. Hitting the Bull's-Eye: Mesothelin's Role as a Biomarker and Therapeutic Target for Malignant Pleural Mesothelioma.
    Yeo D, Castelletti L, van Zandwijk N, Rasko JEJ. · · 2021 · cited 26× · PMID 34439085 · DOI 10.3390/cancers13163932
  6. Targeted Therapy in Mesotheliomas: Uphill All the Way.
    Bertoli E, De Carlo E, Bortolot M, Stanzione B, et al · · 2024 · cited 2× · PMID 38893092 · DOI 10.3390/cancers16111971
  7. Mesothelin biology and the evolving landscape of targeted immunotherapy.
    Boisgard R, Chames P, Kerfelec B. · · 2026 · PMID 41994562 · DOI 10.1016/j.omton.2026.201148
  8. Extracellular payload release from non-internalizing antibody-drug conjugates: mechanisms and linker technologies.
    Feng C, Lou R, Chen S, Lin F, et al · · 2026 · PMID 41866709 · DOI 10.1080/10717544.2026.2645769

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