HER2 Expressing Solid Tumours Clinical Trial
— GBR 1302-101Official title:
A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
| Verified date | October 2020 |
| Source | Ichnos Sciences SA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 36 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Glenmark Investigational Site 103 | Berlin | |
| Germany | Glenmark Investigational Site 102 | Cologne | |
| Germany | Glenmark Investigational Site 101 | Dresden | |
| Germany | Glenmark Investigational Site 104 | Mainz | |
| United States | Glenmark Investigational Site 201 | Dallas | Texas |
| United States | Glenmark Investigational Site 209 | Detroit | Michigan |
| United States | Glenmark Investigational Site 204 | Fairway | Kansas |
| United States | Glenmark Investigational Site 203 | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Ichnos Sciences SA | Glenmark Pharmaceuticals S.A. |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximal Tolerated Dose (MTD) of GBR 1302 | Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort | 28 Days | |
| Primary | The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03 | 28 Days | ||
| Secondary | Objective Response Rate (ORR) for solid tumors. | 2 cycles, 56 days | ||
| Secondary | Disease control rate (DCR) for solid tumors | 2 cycles, 56 days | ||
| Secondary | 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 | ||
| Secondary | Maximum Concentration (Cmax) of GBR 1302 | 28 Days | ||
| Secondary | Time to Maximum Concentration (Tmax) of GBR 1302 | 28 Days | ||
| Secondary | Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 | 28 Days | ||
| Secondary | Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline | 28 Days |