Clinical trial · Interventional
Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
NCT02829372CI-TRIAL-00047591GBR 1302-101terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Expressing Solid Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD3/HER2 bispecific monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GBR 1302
- description
- Dose escalation
- interventionNames
- Drug: CD3/HER2 bispecific monoclonal antibody
Primary outcomes (2)
- measure
- Maximal Tolerated Dose (MTD) of GBR 1302
- timeFrame
- 28 Days
- description
- Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort
- measure
- The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03
- timeFrame
- 28 Days
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.