Clinical trial NCT02829372: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
Official title: A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HER2 Expressing Solid Tumours
Lead sponsor: Ichnos Sciences SA
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2016-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximal Tolerated Dose (MTD) of GBR 1302
timeFrame: 28 Days
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:
measure: Objective Response Rate (ORR) for solid tumors.
timeFrame: 2 cycles, 56 days
measure: Disease control rate (DCR) for solid tumors
timeFrame: 2 cycles, 56 days
measure: 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).
timeFrame: At least 56 days
measure: Maximum Concentration (Cmax) of GBR 1302
timeFrame: 28 Days
measure: Time to Maximum Concentration (Tmax) of GBR 1302
timeFrame: 28 Days
measure: Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302
timeFrame: 28 Days
measure: Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline
timeFrame: 28 Days
Other outcomes:
Locations:
city: Fairway
country: United States
facility: Glenmark Investigational Site 204
state: Kansas
city: Detroit
country: United States
facility: Glenmark Investigational Site 209
state: Michigan
city: Dallas
country: United States
facility: Glenmark Investigational Site 201
state: Texas
city: Salt Lake City
country: United States
facility: Glenmark Investigational Site 203
state: Utah
city: Berlin
country: Germany
facility: Glenmark Investigational Site 103
city: Cologne
country: Germany
facility: Glenmark Investigational Site 102
city: Dresden
country: Germany
facility: Glenmark Investigational Site 101
city: Mainz
country: Germany
facility: Glenmark Investigational Site 104
Study officials:
affiliation: Ichnos Sciences SA
name: Mikhail Khazan, MD
role: STUDY_DIRECTOR
References: