First-in-human Study to Investigate Safety, Blood Levels and Activity of MP0274 in Cancer Patients With HER2-positive Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: MP0274

• Registration Number: NCT03084926
• Lead Sponsor: Molecular Partners AG

Brief Summary

This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for the treatment of HER2-positive cancers. This is the first study of MP0274 in humans and its main purpose is to test its safety and tolerability in patients with HER2-positive cancer. This study will also examine the blood levels of MP0274 at several escalating dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-08-08
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MP0274	MP0274	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	from first infusion to end-of-study visit, up to 12 months	Number and grading according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of MP0274	from first infusion to end-of-study visit, up to 12 months	Serum concentration-time profile of MP0274
Preliminary assessment of anti-tumor activity of MP0274	from first infusion to end-of-study visit, up to 12 months	Efficacy evaluation based on Response Evaluation Criteria in Solid Tumors (RECIST)
Incidence of anti-drug-antibodies	from first infusion to end-of-study visit, up to 12 months	Serum concentration-time profile of anti-drug antibodies

Trial Locations

Locations (4)

Study Site Heidelberg; 🇩🇪 Heidelberg, Germany

Study Site Frankfurt; 🇩🇪 Frankfurt, Germany

Study Site Cambridge; 🇬🇧 Cambridge, United Kingdom

Study Site St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland