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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:

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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 weeks3 visits

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.

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

0 / 6Eligibility criteria met