Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY 94-9343) in Patients with Mesothelin Expressing Advanced or Recurrent Malignancies

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

Detailed description of study

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mesothelin,Neoplasm,Neoplasms,Malignancy,Malignancies,Cancer,Oncology
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Availability of tumor tissue for mesothelin expression testing
Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
At least one measurable lesion
Adequate bone marrow, liver, renal and coagulation function
Exclusion Criteria
More than one prior anti-tubulin/microtubule agent
Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
Contraindication to both CT and MRI contrast agents
Active hepatitis B or C infection
Pregnant or breast-feeding patients
Tumor type specific exclusion criteria

Updated on 04 Aug 2024. Study ID: 1706851679

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