Your session is about to expire
← Back to Search
Monoclonal Antibodies
Monoclonal Antibody Therapy for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Immunitas Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients previously pre-treated with a checkpoint inhibitor must be anti-PD-L1 relapsed/refractory
Patients with specified solid tumor or lymphoma indications and prior treatment as detailed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from informed consent (cycle 0 day -28) to 30 days after the last dose of imt-009. each cycle is 21 days
Awards & highlights
Study Summary
This trial is testing a drug to see if it's safe, how well it works, and what the side effects are for people with solid tumors or lymphomas.
Who is the study for?
Adults over 18 with advanced solid tumors or lymphomas that are progressing, have failed previous treatments, or when standard care isn't an option. Participants must not be on current cancer therapy and should not have serious heart conditions, active infections like HIV/Hepatitis B/C, certain autoimmune diseases, CNS metastases unless stable, or a recent history of severe allergic reactions to monoclonal antibodies.Check my eligibility
What is being tested?
The trial is testing IMT-009's safety and dosage in patients with various cancers. It's an early-stage study (Phase 1/2a) involving multiple centers where participants receive the drug intravenously. Researchers will observe how the body processes IMT-009 and its effectiveness against cancer.See study design
What are the potential side effects?
While specific side effects for IMT-009 aren't listed here, common ones for monoclonal antibody therapies include allergic reactions at the infusion site, fatigue, fever/chills, nausea/vomiting/diarrhea; plus potential impacts on organ function which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer did not respond or stopped responding to previous anti-PD-L1 treatment.
Select...
I have a specific type of solid tumor or lymphoma and have received the detailed treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from informed consent (cycle 0 day -28) to 30 days after the last dose of imt-009. each cycle is 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from informed consent (cycle 0 day -28) to 30 days after the last dose of imt-009. each cycle is 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation - number of participants with dose limiting toxicities (DLTs) from IMT-009 monotherapy
Dose Escalation- Number of participants with adverse events following administration of IMT-009
Phase 2a Cohort(s) Overall Response Rate (ORR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess anti-tumor activity of IMT-009 in each cohort
Secondary outcome measures
Lymphoma
Dose Escalation and Phase 2a Cohort(s)- Duration of Response (DOR) based on RECIST 1.1 or Lugano criteria (lymphomas only) to assess preliminary anti-tumor activity of IMT-009
Dose Escalation and Phase 2a Cohort(s)- Number of participants who develop detectable anti-drug antibodies.
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: IMT-009 Phase 2a Cohort (s)Experimental Treatment1 Intervention
Each Cohort will evaluate IMT-009 monotherapy in up to 25 Participants
Group II: IMT-009 Dose EscalationExperimental Treatment1 Intervention
Participants will receive an assigned dose level of IMT-009 monotherapy in dose escalation. Up to 64 Participants will be enrolled in the Phase 1 portion of the study.
Find a Location
Who is running the clinical trial?
Immunitas TherapeuticsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer did not respond or stopped responding to previous anti-PD-L1 treatment.I have a history of or currently have HIV, Hepatitis B, or C.I have a specific type of solid tumor or lymphoma and have received the detailed treatments.I am 18 years old or older.I had cancer before, but it's been cured and there's been no sign of it for 3 years.I haven't taken systemic treatment for an autoimmune disease in the last 6 months, except for stable hypothyroidism, vitiligo, resolved asthma or alopecia.I haven't had severe immune reactions or needed steroids for them in the last year.I don't have any lasting side effects from previous treatments, except maybe hair loss.My cancer is advanced, cannot be surgically removed, and has not responded to or I cannot undergo standard treatments.I am not on cancer treatment and don't expect to start any during the study.You have had a severe allergic reaction to a specific type of medication called a monoclonal antibody in the past.I haven't had a heart attack or serious heart issues in the last 6 months.My brain metastases have been stable for over 4 weeks, and I haven't taken steroids for at least 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: IMT-009 Dose Escalation
- Group 2: IMT-009 Phase 2a Cohort (s)
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 investigators looking for more test subjects at this time?
"That is accurate. According to the information found on clinicaltrials.gov, this study was originally posted on October 1st, 2022 and is currently looking for 119 patients from 3 hospitals."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger