HER2 Expressing Solid Tumours
Conditions
Brief summary
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
Interventions
DRUGCD3/HER2 bispecific monoclonal antibody
Increasing doses, IV on day 1 and 15 of each 28 day cycle
Sponsors
Glenmark Pharmaceuticals S.A.
Ichnos Sciences SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Tolerated Dose (MTD) of GBR 1302 | 28 Days | Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort |
| The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03 | 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of disease control (measured from drug start date to the date of disease progression or death for subjects who had CR or PR or SD during treatment). | At least 56 days |
| Maximum Concentration (Cmax) of GBR 1302 | 28 Days |
| Objective Response Rate (ORR) for solid tumors. | 2 cycles, 56 days |
| Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 | 28 Days |
| Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline | 28 Days |
| Time to Maximum Concentration (Tmax) of GBR 1302 | 28 Days |
| Disease control rate (DCR) for solid tumors | 2 cycles, 56 days |
Countries
Germany, United States
Outcome results
None listed