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Closed (no longer recruiting)Last updated: 31 January 2024

ARCS Multi-Tumour: This phase I trial is trying to determine the safety and effectiveness of an immunotherapy drug, given alone and as a combination therapy for mesothelin-expressing advanced cancersPhase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

Clinical summary

Summary

This trial is open for recruitment for patients with Breast Cancer (Triple Negative Breast Cancer) and Pancreatic adenocarcinoma. Other cohorts, which are now closed include Non-Small Cell Lung Cancer, Cholangiocarcinoma, Gastric Adenocarcinoma, Thymic carcinoma. Eligible patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine will be administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression.

Conditions

This trial is treating patients with breast or pancreatic cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

ARCS Multi-Tumour

More information

Trial Identifiers

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Trial sponsor

Bayer Inc

Scientific Title

Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

Eligibility

Inclusion

  • Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis
  • Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria
  • Adequate bone marrow, liver, renal and coagulation function
  • Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion

  • Exposure to 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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