EGFR Positive Solid TumorsPhase 1NCT01963715
A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
A Phase 1 study testing IMGN289 in people with EGFR Positive Solid Tumors, run by ImmunoGen, Inc. at 4 sites in United States.
Trial summary
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Positive Solid Tumors
- What is being tested?
- IMGN289
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to Apr 2015
- 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
- 18 years old at time of consent
- Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
- EGFR-positive tumor expression
- Adequate blood and organ function
- Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
- Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements
Who cannot join
- Other anti-cancer treatment during the study
- Symptomatic brain metastases
- Other clinically significant disease as defined by the protocol
- Chronic skin condition that requires prescribed oral or intravenous treatment
- History of severe rash that required discontinuation of prior EGFR targeted therapy
- Receiving therapeutic doses of warfarin or heparin for anti-coagulation
- Known diagnosis of HIV or active viral hepatitis
- Women who are pregnant or breast feeding
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
- Conditions
- EGFR Positive Solid Tumors
- Being tested
- IMGN289
- Keywords
- IMGN289, Antibody Drug Conjugate, antibody, EGFR, NSCLC, SCCHN, Head and neck, Squamous cell carcinoma, Solid tumor, Immunogen, Lung, Phase 1
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMGN289Drug
| Study group | Role | What they receive |
|---|---|---|
| EGFR+ Solid Tumor | Experimental | EGFR+ Solid Tumor Receives: Drug: IMGN289 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities
Measured: Up to 2 years
Secondary outcomes (5)
Number of participants with adverse events
Measured: Up to 2 years
Area under the plasma concentration versus time curve
Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Measured: Up to 2 years
Peak plasma concentration (Cmax) of IMGN289
Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Measured: Up to 2 years
Presence of Human Anti Human Antibody and Human Anti Drug Antibody
Assess whether participants develop an immune response to IMGN289
Measured: Up to 2 years
Tumor measurements per RECIST 1:1
Assess preliminary anti-tumor activity
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Solid TumorsStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Vergara-Silva, MD, Study director, ImmunoGen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963715
- Sponsor's protocol ID
- IMGN0501
- Status last verified
- Sep 2015
- First submitted
- 9 Oct 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
- ClinicalTrials.gov ID
- NCT01963715
- Acronym / sponsor ID
- IMGN0501
- Conditions
- EGFR Positive Solid Tumors
- Keywords
- IMGN289, Antibody Drug Conjugate, antibody, EGFR, NSCLC, SCCHN, Head and neck, Squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ImmunoGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Oct 2013 (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.
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR+ Solid Tumor | Experimental | Drug: IMGN289EGFR+ Solid Tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old at time of consent
- Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
- EGFR-positive tumor expression
- Adequate blood and organ function
- Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
Key exclusion criteria (8 listed)
- Other anti-cancer treatment during the study
- Symptomatic brain metastases
- Other clinically significant disease as defined by the protocol
- Chronic skin condition that requires prescribed oral or intravenous treatment
- History of severe rash that required discontinuation of prior EGFR targeted therapy
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 |
|---|---|---|
| IMGN289 | Drug | EGFR+ Solid Tumor |
Primary outcome
Number of participants with dose limiting toxicities
Time frame: Up to 2 years
5 secondary outcomes
Number of participants with adverse events
Time frame: Up to 2 years
Area under the plasma concentration versus time curve
Time frame: Up to 2 years
Peak plasma concentration (Cmax) of IMGN289
Time frame: Up to 2 years
Presence of Human Anti Human Antibody and Human Anti Drug Antibody
Time frame: Up to 2 years
Tumor measurements per RECIST 1:1
Time frame: Up to 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Related trials for EGFR Positive Solid Tumors
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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
RecruitingEarly Phase 1
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
HER2 Gene Mutation, Advanced Solid Tumors
Active, not recruitingPhase 2
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Locally Advanced or Metastatic Malignant Solid Tumors
Active, not recruitingPhase 1/2
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
Breast Cancer, Solid Tumors
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.
Andrea Vergara-Silva, MD study director
ImmunoGen, Inc.
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 IMGN289 in people with EGFR Positive Solid Tumors, run by ImmunoGen, 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 6 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 2 Oct 2015. 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?
The study was stopped early. 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?
Number of participants with dose limiting toxicities (time frame: Up to 2 years). 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 2 Oct 2015.