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Monoclonal Antibodies

MCLA-145 + Pembrolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Merus N.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or B-cell lymphomas, considered non-amenable to surgery or other curative treatments

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia

Current serious illness or medical condition including uncontrolled active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests MCLA-145, a new drug, on patients with advanced or spreading cancers. It aims to find out if the drug is safe and effective in helping the immune system fight cancer.

Who is the study for?

This trial is for adults with advanced solid tumors or B-cell lymphomas that can't be removed by surgery or cured with other treatments. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), and have tried standard therapies without success. They should not have had more than four prior treatment regimens and must have a life expectancy of at least 12 weeks.

What is being tested?

The study is testing MCLA-145, a bispecific antibody, to see if it's safe and effective for cancer patients when given alongside Pembrolizumab (Keytruda). It's an early-phase trial with two parts: first assessing safety and tolerability, then looking at how well the drugs work against the cancer.

What are the potential side effects?

Possible side effects include those commonly associated with immunotherapies like fatigue, skin reactions, flu-like symptoms, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects related to MCLA-145 are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery or cured with other treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have had up to 4 treatments for my advanced or spreading cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is a specific type of blood cancer.

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I do not have any serious illness or uncontrolled infections.

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I have previously received treatment with drugs targeting PD-L1 or T-cell activation.

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I have experienced severe side effects from previous anti-PD-1 therapy.

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I have an autoimmune disease and have been treated for it in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MCLA-145Experimental Treatment1 Intervention

In Part 1, the dose escalation phase, patients with advanced or recurrent/metastatic solid tumors or B-cell lymphomas will receive escalating doses of MCLA-145 (either Q2W for those patients in treatment at the time of Amendment #4 or Q3W with Amendment #4 approval). Treatment will be with MCLA-145 (monotherapy) for Group A, or in combination with pembrolizumab for Group B, until MTD or RDE is reached. In Part 2, the expansion phase, participants with advanced or metastatic solid tumors will receive intravenous infusion of MCLA-145 either in monotherapy (Group A) or in combination with pembrolizumab (Group B) at the recommended phase II dose every 3 weeks. The duration of each treatment cycle is 21 days

Group II: Group B Combination TreatmentExperimental Treatment2 Interventions

Patients in Group B will be treated with MCLA-145 in Combination with pembrolizumab 200mg Q3W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab (Keytruda)

2020

Completed Phase 1

~10

0 / 8Eligibility criteria met