Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with<br>mesothelin expressing advanced or recurrent malignancies

Completed

• Conditions: neoplasmata maligne en niet-gespecificeerd van de borst, maagdarmstelsel, lever- en galwegen en endocriene organen; mesothelin expressing advanced or recurrent malignancies; multi-indication

• Registration Number: NL-OMON48947
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

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 according to either RECIST 1.1 or ITMIG modified RECIST 1.1 as applicable
- Adequate bone marrow, liver, renal and coagulation function
- LVEF * 50% of the lower limit of normal (LLN) according to local institutional ranges
- ECOG 0 or 1
- Availability of additional tumor tissue for further biomarker analysis

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Maximum tolerated dose (MTD) of anetumab ravtansine in combination with<br /><br>cisplatin and in combination with gemcitabine in patients with<br /><br>mesothelin-expressing cholangiocarcinoma and pancreatic adenocarcinoma.<br /><br>Timeframe of Measurement: At least 3 weeks after the last patient starts<br /><br>treatment.<br /><br><br /><br>2) Objective response rate (ORR) of anetumab ravtansine for monotherapy and<br /><br>combination therapy in mesothelin expressing advanced solid tumors. Timeframe<br /><br>of measurement: 18 weeks after last patient starts treatment.<br /><br>Durable Disease Control Rate (DDCR) as dual primary variables in pancreatic and<br /><br>gastric cancer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Number of serious and non-serious adverse events (AEs) of the respective<br /><br>anetumab ravtansine monotherapy or combination treatments in the respective<br /><br>indications of mesothelin expressing advanced solid tumors. Timeframe of<br /><br>Measurement: 18 weeks after last patient starts treatment.<br /><br><br /><br>2) Disease control rate (DCR). Timeframe of Measurement: 18 weeks after last<br /><br>patient starts treatment.<br /><br><br /><br>3) Duration of response (DOR). Timeframe of Measurement: Approximately 24<br /><br>months after last patient starts treatment.<br /><br><br /><br>4) Durable response rate (DRR). Timeframe of Measurement: Approximately 24<br /><br>months after last patient starts treatment.<br /><br><br /><br>5) Progression free survival (PFS). Timeframe of Measurement: Approximately 24<br /><br>months after last patient starts treatment.</p><br>