HER2-positive Solid CancersPhase 1MT-5111NCT04029922
Study of MT-5111 in HER2-positive Solid Tumors
A Phase 1 study testing MT-5111 (experimental study drug) in people with HER2-positive Solid Cancers, run by Molecular Templates, Inc. at 30 sites in 3 countries.
Trial summary
This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Solid Cancers
- What is being tested?
- MT-5111 (experimental study drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 12 Nov 2019to 27 Apr 2023
- 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
- Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
- Part A (Dose-Escalation): All HER2-positive solid cancers are eligible
- Part B (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, and gastric or gastroesophageal adenocarcinomas (GEA).
- HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
- Relapsed or refractory to or intolerant of existing therapy(ies)
- At least 1 measurable or evaluable lesion according to RECIST 1.1 (Subjects with evaluable disease only may be included in the dose escalation phase)
Show all 19Show fewer
- ECOG performance score of ≤ 1
- Adequate Bone marrow function as determined by:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 75,000 mm³ and
- Hemoglobin ≥ 8.0 g/dL
- Red blood cell transfusion within 2 weeks of study treatment start is allowed if hemoglobin levels remain stable
- Kidney function:
- Creatinine clearance (CLcr) ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula
- Cardiac Function:
- Left ventricular ejection fraction (LVEF) ≥ 55% on the echocardiogram (ECHO) assessment (preferred), or multigated acquisition (MUGA) scan, and QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men [average from three QTcF values on the triplicate 12-lead electrocardiogram (ECG)] at baseline
- Hepatic function:
- Total bilirubin ≤ 1.5 x ULN, or ≤ 3 x ULN for subjects with Gilbert's Syndrome and
- AST ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis) and ALT ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis)
Who cannot join
- History or current evidence of another tumor that is histologically distinct from the tumor under study
- Current evidence of new or growing CNS metastases during screening
- Subjects with known CNS metastases will be eligible if they meet protocol specified criteria
- Evidence of CTCAE Grade >1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria
- History or evidence of significant cardiovascular disease
- Current evidence of active, uncontrolled hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) (evidenced by detectable viral load by PCR) or acquired immunodeficiency syndrome (AIDS) related illness
- Current evidence of ≥ grade 2 underlying pulmonary disease
- Certain exclusionary prior treatments
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
Novant Health Cancer Institute
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
Sylvester Comprehensive Cancer Center (University of Miami)
Coral Gables, Florida, 33146
Mary Crowley Cancer Research
Dallas, Texas, 75251
Sarah Cannon Research Institute
Denver, Colorado, 80218
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Prisma Health
Greenville, South Carolina, 29605
South Broward Hospital District d/b/a Memorial Healthcare System
Hollywood, Florida, 33021
Mayo Clinic (Florida)
Jacksonville, Florida, 32224
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Orlando Health
Orlando, Florida, 32806
South Broward Hospital District d/b/a Memorial Healthcare System
Pembroke Pines, Florida, 33024
Mayo Clinic (Arizona)
Phoenix, Arizona, 85054
BRCR Medical Center
Plantation, Florida, 33322
Mayo Clinic (Minnesota)
Rochester, Minnesota, 55905
The University of Texas Health Science Center
San Antonio, Texas, 78229
Cedars-Sinai Medical Center
Santa Monica, California, 90048
UCLA Hematology & Oncology
Santa Monica, California, 90404
Washington University
St Louis, Missouri, 63130
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Australia6 sites
Cancer Research South Australia
Adelaide, South Australia, 5000
Southern Highlands Cancer Centre
Bowral, New South Wales, 2576
St. Vincent's Hospital Melbourne
Fitzroy, Melbourne, VIC, 3065
Macquarie University Hospital (Clinical Trials Unit)
Macquarie, New South Wales, 2109
Sunshine Hospital - Western Health
Saint Albans, Victoria, 3021
Goulburn Valley Health
Shepparton, Victoria, 3630
New Zealand1 site
New Zealand Clinical Research (Christchurch)
Christchurch, 8011
About this study
Official title: A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors
This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors
Read the detailed description
This study will be conducted in two parts:
Part A (Dose Escalation): The purpose of Part A is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Part A will include any type of HER2-positive solid cancer.
Part B (Dose Expansion): The purpose of Part B is to confirm the safety and tolerability of MT-5111 doses selected from those explored in Part A including the MTD or RP2D. Part B will include 3 types of HER2-positive solid cancers in the following 3 expansion groups: Group B1: Breast cancer; Group B2: gastric or gastroesophageal adenocarcinomas (GEA); and Group B3: Other HER2-positive solid cancers.
The Breast Cancer cohort will start enrolling in parallel to Part A.
Up to 178 eligible subjects will be identified and treated through competitive enrollment at multiple study centers globally
In Parts A and B of the study, a subject may participate for the following four periods:
Screening (up to 28 days before first dose of MT-5111)
Treatment period (active period where a subject will receive three weekly doses of MT-5111 over a 21-day treatment cycle)
Short-term Follow-up (30 days after last dose of MT-5111)
Long-term follow-up (up to 24 months after the last dose of MT-5111)
MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle, a cycle being defined as 21 days). A subject can continue receiving MT-5111 as long as it is well-tolerated, their disease has not worsened, or until the subject decides they no longer want to participate in the study.
- Conditions
- HER2-positive Solid Cancers
- Being tested
- MT-5111 (experimental study drug)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-5111 (experimental study drug)Drug
Experimental treatment with MT-5111
| Study group | Role | What they receive |
|---|---|---|
| Part A- Dose Escalation | Experimental | Part A- Dose Escalation in patients with previously treated advanced HER2-positive solid tumors.
The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle). Receives: Drug: MT-5111 (experimental study drug) |
| Part B- Dose Expansion | Experimental | Part B - Dose Expansion in previously treated HER2-positive breast, GEA and other HER2-positive solid cancers
Part B will include 3 expansion groups: Group B1 (Breast Cancer) will begin enrolling while Part A is being conducted following the completion of Cohort 7 and Subsequent cohort of subjects in group B1 may enroll into higher doses that are tolerated in Part A. Group B2 (GEA) and Group B3 (Other HER-2 positive solid cancer groups) will begin enrollment after the MTD or RP2D is determined in Part A.
The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle). Receives: Drug: MT-5111 (experimental study drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Evaluation of safety of MT-5111 as measured by number of subjects with adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Measured: 21 day cycle
To evaluate tolerability and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Evaluation of tolerability of MT-5111 as measured by number of subjects with dose limiting toxicities (DLTs)
Measured: 21 day cycle
Secondary outcomes (6)
PK as measured by concentrations of free MT-5111 (Maximum Plasma Concentration [Cmax])
Evaluation of the pharmacokinetic profile of MT-5111
Measured: Day 1, Day 8, and Day 15 in Each 21-Day cycle
PK as measured by concentrations of free MT-5111 (Time to reach maximum concentration after drug administration [Tmax])
Evaluation of the pharmacokinetic profile of MT-5111
Measured: Day 1, Day 8, and Day 15 in Each 21-Day cycle
PK as measured by concentrations of free MT-5111 (Area Under the Curve [AUC])
Evaluation of the pharmacokinetic profile of MT-5111
Measured: Day 1, Day 8, and Day 15 in Each 21-Day cycle
To evaluate the tumor response to MT-5111
Objective response rate (ORR) defined as the proportion of subjects with either a complete response or a partial response as determined by investigator assessment
Measured: Screening, approximately every 6 weeks, at End of Treatment and 30 days after the last dose
To evaluate the immunogenicity of MT-5111
Immunogenicity as measured by MT-5111 (anti-drug antibody [ADA] titer)
Measured: Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
To evaluate the immunogenicity of MT-5111
Immunogenicity as measured by MT-5111 (neutralizing antibody [NAb])
Measured: Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start12 Nov 2019
- Primary completion1 Feb 2023
- Study completion27 Apr 2023
Why it stopped: Study Reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Solid CancersStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- MT-5111 (active drug)
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Templates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029922
- Sponsor's protocol ID
- MT-5111_001
- Acronym
- MT-5111
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2019
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors
- ClinicalTrials.gov ID
- NCT04029922
- Acronym / sponsor ID
- MT-5111 / MT-5111_001
- Conditions
- HER2-positive Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Reprioritization
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Molecular Templates, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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.
This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors
Detailed description
This study will be conducted in two parts:
Part A (Dose Escalation): The purpose of Part A is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Part A will include any type of HER2-positive solid cancer.
Part B (Dose Expansion): The purpose of Part B is to confirm the safety and tolerability of MT-5111 doses selected from those explored in Part A including the MTD or RP2D. Part B will include 3 types of HER2-positive solid cancers in the following 3 expansion groups: Group B1: Breast cancer; Group B2: gastric or gastroesophageal adenocarcinomas (GEA); and Group B3: Other HER2-positive solid cancers.
The Breast Cancer cohort will start enrolling in parallel to Part A.
Up to 178 eligible subjects will be identified and treated through competitive enrollment at multiple study centers globally
In Parts A and B of the study, a subject may participate for the following four periods:
Screening (up to 28 days before first dose of MT-5111)
Treatment period (active period where a subject will receive three weekly doses of MT-5111 over a 21-day treatment cycle)
Short-term Follow-up (30 days after last dose of MT-5111)
Long-term follow-up (up to 24 months after the last dose of MT-5111)
MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle, a cycle being defined as 21 days). A subject can continue receiving MT-5111 as long as it is well-tolerated, their disease has not worsened, or until the subject decides they no longer want to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MT-5111 (active drug)
| Arm | Type | Receives |
|---|---|---|
| Part A- Dose Escalation | Experimental | Drug: MT-5111 (experimental study drug)Part A- Dose Escalation in patients with previously treated advanced HER2-positive solid tumors. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle). |
| Part B- Dose Expansion | Experimental | Drug: MT-5111 (experimental study drug)Part B - Dose Expansion in previously treated HER2-positive breast, GEA and other HER2-positive solid cancers Part B will include 3 expansion groups: Group B1 (Breast Cancer) will begin enrolling while Part A is being conducted following the completion of Cohort 7 and Subsequent cohort of subjects in group B1 may enroll into higher doses that are tolerated in Part A. Group B2 (GEA) and Group B3 (Other HER-2 positive solid cancer groups) will begin enrollment after the MTD or RP2D is determined in Part A. The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
- HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
- Relapsed or refractory to or intolerant of existing therapy(ies)
- At least 1 measurable or evaluable lesion according to RECIST 1.1 (Subjects with evaluable disease only may be included in the dose escalation phase)
- ECOG performance score of ≤ 1
Key exclusion criteria (8 listed)
- History or current evidence of another tumor that is histologically distinct from the tumor under study
- Current evidence of new or growing CNS metastases during screening
- Evidence of CTCAE Grade >1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria
- History or evidence of significant cardiovascular disease
- Current evidence of active, uncontrolled hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) (evidenced by detectable viral load by PCR) or acquired immunodeficiency syndrome (AIDS) related illness
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 |
|---|---|---|
| MT-5111 (experimental study drug)Experimental treatment with MT-5111 | Drug | Part A- Dose Escalation, Part B- Dose Expansion |
Primary outcome
To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Time frame: 21 day cycle
Evaluation of safety of MT-5111 as measured by number of subjects with adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
To evaluate tolerability and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Time frame: 21 day cycle
Evaluation of tolerability of MT-5111 as measured by number of subjects with dose limiting toxicities (DLTs)
6 secondary outcomes
PK as measured by concentrations of free MT-5111 (Maximum Plasma Concentration [Cmax])
Time frame: Day 1, Day 8, and Day 15 in Each 21-Day cycle
PK as measured by concentrations of free MT-5111 (Time to reach maximum concentration after drug administration [Tmax])
Time frame: Day 1, Day 8, and Day 15 in Each 21-Day cycle
PK as measured by concentrations of free MT-5111 (Area Under the Curve [AUC])
Time frame: Day 1, Day 8, and Day 15 in Each 21-Day cycle
To evaluate the tumor response to MT-5111
Time frame: Screening, approximately every 6 weeks, at End of Treatment and 30 days after the last dose
To evaluate the immunogenicity of MT-5111
Time frame: Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
To evaluate the immunogenicity of MT-5111
Time frame: Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
Results and safety
The study was stopped early (reason given: Study Reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-5111 (experimental study drug) in people with HER2-positive Solid Cancers, run by Molecular Templates, Inc. at 30 sites in 3 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 19 inclusion and 8 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, New Zealand. 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 Reprioritization). 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?
To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) (time frame: 21 day cycle). 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 18 Jun 2023.