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 |
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
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
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