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Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers

A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers

NCT02829372•Ichnos Sciences SA

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Progressive HER2 positive solid tumours (immunohistochemistry \[IHC\] positive or equivocal) with no available standard or curative treatment.
•2. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

Exclusion Criteria

•1. Active infectious disease considered by the Investigator to be incompatible with the protocol.
•2. Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ≤ Grade 1 except in case of liver metastases or Gilbert's Syndrome or alopecia.
•3. Brain metastases that are symptomatic or untreated or that require current therapy.
•4. Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.
•5. Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.

Locations (8)

Glenmark Investigational Site 204

Fairway, Kansas, United States

Glenmark Investigational Site 209

Detroit, Michigan, United States

Glenmark Investigational Site 201

Dallas, Texas, United States

Glenmark Investigational Site 203

Salt Lake City, Utah, United States

Glenmark Investigational Site 103

Berlin, Germany

Glenmark Investigational Site 102

Cologne, Germany

Glenmark Investigational Site 101

Dresden, Germany

Glenmark Investigational Site 104

Mainz, Germany

Key Dates

Start Date

May 1, 2016

Primary Completion Date

May 1, 2019

Completion Date

May 1, 2019

Last Updated

October 9, 2020

Enrollment

ACTUAL participants

Conditions

HER2 Expressing Solid Tumours

Interventions

CD3/HER2 bispecific monoclonal antibody

DRUG