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Monoclonal Antibodies
IMGC936 for Advanced Solid Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunoGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to end of study (approximately up to 2 years) for each patient
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. So far, it seems to be working well with few side effects.
Who is the study for?
This trial is for adults with certain advanced solid tumors who've had limited prior treatments, have acceptable organ function and performance status, and are not pregnant or breastfeeding. They must use effective contraception and cannot have active central nervous system disease, serious heart conditions, uncontrolled infections, or recent major surgeries.Check my eligibility
What is being tested?
IMGC936 is being tested in this early-phase study to evaluate its safety and how well it works against advanced solid tumors. Participants will receive the drug through an IV infusion. The study includes initial dose testing followed by a phase where more patients receive the drug to further assess its effects.See study design
What are the potential side effects?
As IMGC936 is a new treatment under investigation, potential side effects include typical reactions related to immune therapies such as fatigue, allergic reactions during infusion, possible inflammation of organs but specific side effect profiles will be characterized during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pancreatic cancer and have had 1-3 treatments, with no more than 2 being chemotherapy.
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I have had 1 to 3 treatments for colorectal cancer.
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My cancer has returned or didn't respond to treatment and no other effective therapy is available.
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My white blood cell count is healthy without medication.
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My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.
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I have triple-negative breast cancer and received 1-4 treatments for it after it spread.
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I've had 1-4 treatments for NSCLC, with no more than 2 involving chemotherapy.
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I am 18 years old or older.
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I have had 1 to 3 treatments for my gastroesophageal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening to end of study (approximately up to 2 years) for each patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to end of study (approximately up to 2 years) for each patient
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
During dose escalation characterize dose-limiting toxicities (DLTs)
During dose escalation measure incidence and severity of Treatment Emergent Adverse Events by CTCAE v5.0
During expansion describe the Overall Response Rate for IMGC936 using RECIST v1.1
Secondary outcome measures
During dose escalation and expansion to characterize study drug concentration
During dose escalation and expansion to measure the concentration of anti-drug antibody
During dose escalation to describe the objective response rate and duration of response
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IMGC936Experimental Treatment1 Intervention
Single-arm. IMGC936 administered every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMGC936
2020
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
31 Previous Clinical Trials
3,749 Total Patients Enrolled
MacroGenicsIndustry Sponsor
48 Previous Clinical Trials
5,320 Total Patients Enrolled
CMO ImmunoGenStudy DirectorImmunoGen, Inc.
1 Previous Clinical Trials
366 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a tissue sample for testing, either already collected or through a new biopsy.I do not have an active hepatitis B or C infection.I have a cytomegalovirus infection.I have pancreatic cancer and have had 1-3 treatments, with no more than 2 being chemotherapy.I do not have severe heart failure.I have had 1 to 3 treatments for colorectal cancer.I do not have serious heart rhythm problems that aren't well-managed with medication.I have not had major surgery or serious injury in the last 4 weeks.I do not have ongoing serious eye problems or a history of major eye surgery.I have had a bone marrow, stem cell, or organ transplant in the past.I have had active brain or spinal cord disease in the last 6 months.I do not have any serious illnesses or active infections.I have not had a stroke or mini-stroke in the last 6 months.I have had treatments within the specified times.I am a woman of childbearing potential and not pregnant, with a negative pregnancy test.My cancer has returned or didn't respond to treatment and no other effective therapy is available.My cancer's size or presence can be seen on a CT or MRI scan taken recently.My white blood cell count is healthy without medication.I haven't had a live virus vaccine in the last 4 weeks, except for the flu shot.I am mostly active and can care for myself.My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.I have triple-negative breast cancer and received 1-4 treatments for it after it spread.I have had another cancer, but it's been in remission for over 2 years, except for certain less serious types.I am HIV positive.I've had 1-4 treatments for NSCLC, with no more than 2 involving chemotherapy.I am 18 years old or older.I do not need extra oxygen (except for sleep apnea) and have not had severe lung inflammation from drugs or radiation.I haven't needed IV antibiotics for an infection in the last 2 weeks.I have recovered from side effects of previous treatments, except for hair loss.I haven't had chest or pelvic radiation in the last 6 weeks, but may have had small area radiation for pain in the last 2 weeks.I do not have an active COVID-19 infection.I haven't had cancer drugs for at least 4 weeks or 5 half-lives, whichever is shorter.I do not have current pericarditis or significant fluid around my heart.I currently have myocarditis.My cancer may or may not show up on scans.My cancer can be measured by tests or scans.I do not have serious heart problems.I have not had a heart attack or unstable chest pain in the last 6 months.I have had 1 to 3 treatments for my gastroesophageal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: IMGC936
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available to take part in this experiment?
"The data on clinicaltrials.gov demonstrates that this medical study is actively recruiting patients, having been first listed at the end of October 2020 and last edited in late June 2022."
Answered by AI
What primary goals is this clinical trial seeking to accomplish?
"According to the sponsor of this study, MacroGenics, there are three primary outcomes. The first is a measure of Treatment Emergent Adverse Events over two years by CTCAE v5.0. As well as this, they will be assessing Anti-Drug Antibody concentration during dose escalation and Time To Disease Progression in terms of objective response rate and duration throughout the same period respectively. Lastly, Number Of Treatment Emergent Adverse Events assessed by CTCAE v5.0 will be monitored during expansion stages too."
Answered by AI
How many participants are being considered for enrollment in this research endeavor?
"MacroGenics, the primary sponsor of this trial, requires 245 qualified participants to move forward with their research. The study will be conducted at MD Anderson Cancer Center in Houston and Dana-Farber Cancer Institute in Boston."
Answered by AI
At how many sites is this clinical research being conducted?
"The recruitment efforts for this clinical trial have extended to seven different sites. Among them there is the MD Anderson Cancer Center in Houston, Dana-Farber Cancer Institute in Boston, and Washington University in Saint Louis."
Answered by AI
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