Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (GBR 1302-101)

Ichnos Sciences

Status and phase: Terminated; Phase 1

Conditions: HER2 Expressing Solid Tumours

Treatments: Drug: CD3/HER2 bispecific monoclonal antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT02829372

2015-002926-38 (EudraCT Number)

GBR 1302-101

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

GBR 1302

Experimental group

Description:

Dose escalation

Treatment:

Drug: CD3/HER2 bispecific monoclonal antibody