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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Jacksonville, Fla.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available
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CLS-20379674

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