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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:May 2016
End Date:November 2019
Contact:Phumla Adesanya
Email:clinicaltrialsdisclosuredesk@glenmarkpharma.com
Phone:(201) 684-8000

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

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


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.
We found this trial at
5
sites
Dallas, Texas 75230
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Dallas, TX
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Berlin, 10117
Phone: +49 30 450 564 621
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Berlin,
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Detroit, Michigan 48201
Phone: 313-576-8624
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Detroit, MI
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Fairway, Kansas 66205
Phone: 913-558-6029
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Fairway, KS
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Salt Lake City, Utah 84112
Phone: 801-587-4700
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Salt Lake City, UT
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