HER2 Expressing Solid TumoursPhase 1GBR 1302-101NCT02829372
Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
A Phase 1 study testing CD3/HER2 bispecific monoclonal antibody in people with HER2 Expressing Solid Tumours, run by Ichnos Sciences SA at 8 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Expressing Solid Tumours
- What is being tested?
- CD3/HER2 bispecific monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2016to May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Who cannot join
- Active infectious disease considered by the Investigator to be incompatible with the protocol.
- 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.
- Brain metastases that are symptomatic or untreated or that require current therapy.
- 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.
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Glenmark Investigational Site 201
Dallas, Texas, 75230
Glenmark Investigational Site 209
Detroit, Michigan, 48201
Glenmark Investigational Site 204
Fairway, Kansas, 66205
Glenmark Investigational Site 203
Salt Lake City, Utah, 84112
Germany4 sites
Glenmark Investigational Site 103
Berlin, 10117
Glenmark Investigational Site 102
Cologne, 50670
Glenmark Investigational Site 101
Dresden, 01307
Glenmark Investigational Site 104
Mainz, 55131
About this study
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
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
- HER2 Expressing Solid Tumours
- Being tested
- CD3/HER2 bispecific monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD3/HER2 bispecific monoclonal antibodyDrug
Increasing doses, IV on day 1 and 15 of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| GBR 1302 | Experimental | Dose escalation Receives: Drug: CD3/HER2 bispecific monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 Days
The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03
Measured: 28 Days
Secondary outcomes (7)
Objective Response Rate (ORR) for solid tumors.
Measured: 2 cycles, 56 days
Disease control rate (DCR) for solid tumors
Measured: 2 cycles, 56 days
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).
Measured: At least 56 days
Maximum Concentration (Cmax) of GBR 1302
Measured: 28 Days
Time to Maximum Concentration (Tmax) of GBR 1302
Measured: 28 Days
Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302
Measured: 28 Days
Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Expressing Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichnos Sciences SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Mikhail Khazan, MD, Study director, Ichnos Sciences SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829372
- Sponsor's protocol ID
- GBR 1302-101
- Other IDs
- 2015-002926-38, 2015
- Acronym
- GBR 1302-101
- Status last verified
- Oct 2020
- First submitted
- 1 Jul 2016
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02829372
- Acronym / sponsor ID
- GBR 1302-101 / GBR 1302-101
- Conditions
- HER2 Expressing Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ichnos Sciences SAIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- May 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBR 1302 | Experimental | Drug: CD3/HER2 bispecific monoclonal antibodyDose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Key exclusion criteria (5 listed)
- Active infectious disease considered by the Investigator to be incompatible with the protocol.
- 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.
- Brain metastases that are symptomatic or untreated or that require current therapy.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD3/HER2 bispecific monoclonal antibodyIncreasing doses, IV on day 1 and 15 of each 28 day cycle | Drug | GBR 1302 |
Primary outcome
Maximal Tolerated Dose (MTD) of GBR 1302
Time frame: 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
Time frame: 28 Days
7 secondary outcomes
Objective Response Rate (ORR) for solid tumors.
Time frame: 2 cycles, 56 days
Disease control rate (DCR) for solid tumors
Time frame: 2 cycles, 56 days
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).
Time frame: At least 56 days
Maximum Concentration (Cmax) of GBR 1302
Time frame: 28 Days
Time to Maximum Concentration (Tmax) of GBR 1302
Time frame: 28 Days
Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302
Time frame: 28 Days
Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline
Time frame: 28 Days
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Related trials for HER2 Expressing Solid Tumours
RecruitingPhase 2
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Breast Cancer, Gastric Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Active, not recruitingPhase 1/2
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms
RecruitingPhase 1
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Khazan, MD study director
Ichnos Sciences SA
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD3/HER2 bispecific monoclonal antibody in people with HER2 Expressing Solid Tumours, run by Ichnos Sciences SA at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose (MTD) of GBR 1302 (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.