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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
Must not have
Patient has history of or current HIV, Hepatitis B or C infection, even if not active and/or controlled
Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment within the 12 months prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 to 90 days after treatment discontinuation, up to 2 years. dose escalation, pde and phase 2a cycles are 21 days. phase 1b cycles are 28 days.
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My cancer did not respond or stopped responding to previous anti-PD-L1 treatment.
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I have a specific type of solid tumor or lymphoma and have received the detailed treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of or currently have HIV, Hepatitis B, or C.
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I haven't had severe immune reactions or needed steroids for them in the last year.
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I am not on cancer treatment and don't expect to start any during the study.
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I haven't had a heart attack or serious heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 to 90 days after treatment discontinuation, up to 2 years. dose escalation, pde and phase 2a cycles are 21 days. phase 1b cycles are 28 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 to 90 days after treatment discontinuation, up to 2 years. dose escalation, pde and phase 2a cycles are 21 days. phase 1b cycles are 28 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Dose Escalation, PDE, Phase 1b and Phase 2a Cohort(s) - Pharmacokinetic Analysis: Clearance of IMT-009 when given as monotherapy or in combination.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment 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 Phase 1bExperimental Treatment2 Interventions
Participants will receive an assigned dose level of IMT-009 in combination with standard of care fruquintinib. Up to 12 Participants will be enrolled in the Phase 1b portion of the study
Group III: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruquintinib
2021
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

Immunitas TherapeuticsLead Sponsor

Media Library

IMT-009 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05565417 — Phase 1 & 2
Follicular Lymphoma Research Study Groups: IMT-009 Phase 1b, IMT-009 Dose Escalation, IMT-009 Phase 2a Cohort (s)
Follicular Lymphoma Clinical Trial 2023: IMT-009 Highlights & Side Effects. Trial Name: NCT05565417 — Phase 1 & 2
IMT-009 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565417 — Phase 1 & 2
~27 spots leftby Apr 2025