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

Stopped early · Phase 1

Conditions studied: HER2 Expressing Solid Tumours

In brief

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

Key facts

Study ID

NCT02829372

Run by

Ichnos Sciences SA

People needed

36

Starts

2016-05-01

Expected to finish

2019-05-01

Last updated by the study team

2020-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Active infectious disease considered by the Investigator to be incompatible with the protocol.
• 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.
• Brain metastases that are symptomatic or untreated or that require current therapy.
• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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