Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT03859752
TR1801-ADC in Patients With Tumors That Express c-Met
A Phase 1 study testing TR1801-ADC in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Open Innovation Partners, Inc. at 4 sites in United States.
Trial summary
First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- TR1801-ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Aug 2019to 31 Dec 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
- Compliance with all study procedures and visits to the clinical research site
- Locally advanced or metastatic disease that is not amenable to definitive therapy
- Histologically confirmed diagnosis of a solid tumor which expresses c-Met
- Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type
- Measurable baseline disease as defined by RECIST Version 1.1
- ECOG Performance Status 0-1
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- Body weight within 40 and 150 kg
- Clinical laboratory values with the limits as defined by the protocol
- Not pregnant or breast feeding
- Males and women of child-bearing potential must agree to use an effective method of contraception
Who cannot join
- Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures
- Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment
- Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for <2 weeks
- Unresolved adverse events >= Grade 2 from prior anticancer therapies
- Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study.
- Uncontrolled hypertension, unstable angina, or NYHA Class III/IV heart failure
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- History of capillary leak syndrome
- Corticosteroid intolerance
- History of anasarca
- Untreated or uncontrolled bacterial, viral or fungal infection
- HIV infection or active infection with hepatitis B or C
- Significant liver disease
- History of alcoholism or current alcoholism
- Signs of significant portal hypertension
- Significant kidney disease within 2 years
- Active or unstable gallstone disease
- Prior treatment with a c-Met targeted agent
- Prior hypersensitivity reaction to treatment with another monoclonal antibody
- QTcF >=470 ms
- Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment
- Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado
Aurora, Colorado, 80045
John Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Washington / Seattle Cancer Care
Seattle, Washington, 98109
About this study
Official title: A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met
First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.
Read the detailed description
First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.
- Being tested
- TR1801-ADC
- Keywords
- antibody-drug conjugate, c-Met, solid tumors, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR1801-ADCBiological
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
| Study group | Role | What they receive |
|---|---|---|
| TR1801-ADC | Experimental | Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin Receives: Biological: TR1801-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
Number of participants with treatment-related adverse events
Measured: 4 years
Establish maximum tolerated dose
Number of participants with protocol-defined dose-limiting toxicity
Measured: 3.5 years
Secondary outcomes (3)
Evaluate pharmacokinetics of TR1801-ADC
Analyze blood plasma concentrations
Measured: 4 years
Immunogenicity
Assess anti-drug antibodies of TR1801-ADC
Measured: 4 years
Evaluate clinical activity of TR1801-ADC
Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start14 Aug 2019
- Primary completion4 Jul 2023
- Study completion31 Dec 2023 (estimated)
Why it stopped: Financial funds were withdrawn by investors and study was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Model description
- Open label, multiple dose, dose-escalation
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Open Innovation Partners, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilad Gordon, MD, Study director, Open Innovation Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859752
- Sponsor's protocol ID
- TR1801-CL-01
- Status last verified
- Jul 2023
- First submitted
- 26 Feb 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met
- ClinicalTrials.gov ID
- NCT03859752
- Acronym / sponsor ID
- TR1801-CL-01
- Keywords
- antibody-drug conjugate, c-Met, solid tumors, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Financial funds were withdrawn by investors and study was stopped
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Open Innovation Partners, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Mar 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.
First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.
Detailed description
First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, multiple dose, dose-escalation
| Arm | Type | Receives |
|---|---|---|
| TR1801-ADC | Experimental | Biological: TR1801-ADCHumanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Compliance with all study procedures and visits to the clinical research site
- Locally advanced or metastatic disease that is not amenable to definitive therapy
- Histologically confirmed diagnosis of a solid tumor which expresses c-Met
- Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type
- Measurable baseline disease as defined by RECIST Version 1.1
Key exclusion criteria (21 listed)
- Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures
- Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment
- Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for <2 weeks
- Unresolved adverse events >= Grade 2 from prior anticancer therapies
- Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study.
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 |
|---|---|---|
| TR1801-ADCHumanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin | Biological | TR1801-ADC |
Primary outcome
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
Time frame: 4 years
Number of participants with treatment-related adverse events
Establish maximum tolerated dose
Time frame: 3.5 years
Number of participants with protocol-defined dose-limiting toxicity
3 secondary outcomes
Evaluate pharmacokinetics of TR1801-ADC
Time frame: 4 years
Immunogenicity
Time frame: 4 years
Evaluate clinical activity of TR1801-ADC
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Gilad Gordon, MD study director
Open Innovation Partners
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TR1801-ADC in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Open Innovation Partners, Inc. at 4 sites in United States.
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 10 inclusion and 21 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: paused, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
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?
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met (time frame: 4 years). 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 22 Sep 2023.