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MQ710 + Pembrolizumab for Solid Tumor Cancers

Phase 1

Waitlist Available

Led By Lara Dunn, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Age 18 or over

Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical/radiotherapy, targeted therapy, or major surgery (but not anti-PD1/- L1 therapies) was discontinued for more than 4 weeks prior to enrollment

Must not have

History of chronic liver disease or evidence of hepatic cirrhosis

History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of a new drug, MQ710, on people with advanced or relapsed solid tumor cancers. It will find the best dose with fewest side effects.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumor cancers that have relapsed, worsened after standard treatments, or have no standard treatment options. Eligible participants include those with specific skin cancers and head and neck squamous cell carcinoma who've failed previous therapies including anti-PD-1 therapy (except HNSCC patients with low PD-L1 expression). Participants must be in good enough health to comply with study procedures, not pregnant, willing to use contraception, and free from significant recent medical issues.

What is being tested?

The study aims to determine the highest dose of MQ710 that can be given safely alongside Pembrolizumab in people with various types of solid tumors. It will involve individuals whose cancer has returned at the original site or spread elsewhere and is resistant to conventional treatments or lacks such options.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions associated with immunotherapy drugs like inflammation in organs, infusion-related reactions, fatigue, digestive problems, blood disorders, increased risk of infections as well as any adverse effects related to the new drug's mechanism which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I stopped any cancer treatments except for anti-PD1/-L1 more than 4 weeks ago.

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I have had a biopsy to check my condition.

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My advanced cancer has not responded to 2 previous treatments, or there are fewer than 2 standard treatments available.

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I have no curative treatment options left or they come with high risks.

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

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My kidney function is good with a creatinine level below 2 mg/dL.

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 chronic liver disease or cirrhosis.

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I have an autoimmune disease treated with medication in the last 2 years.

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I do not have active viral diseases like hepatitis or HIV, nor have I taken antiviral treatments recently.

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I have been hospitalized for serious bleeding in the last year.

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I haven't had severe bleeding or blood clot issues in the last 3 months.

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My tumor is affecting major blood vessels or organs, risking perforation.

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I do not have any ongoing infections needing antibiotics or causing frequent high fevers.

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I have had radiation treatment before that included my carotid arteries.

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I have not had serious heart problems or strokes in the last 6 months.

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I have had my spleen removed.

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My cancer has spread to my brain or its coverings.

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I need blood-thinning medication like warfarin.

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I have a history of lung conditions like pulmonary fibrosis or pneumonitis.

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I have not received a live vaccine in the last 28 days.

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I haven't had immune therapy treatments in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of MQ710 by review of AEs and SAEs

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: Dose Expansion GroupExperimental Treatment2 Interventions

MQ710 + pembrolizumab Approximately 8 patients will be recruited into the dose expansion group for monotherapy dosing of MQ710. Approximately 12 patients will be recruited for dosing at the MTD/maximally administered dose established in combination with pembrolizumab.

Group II: Dose Escalation GroupExperimental Treatment1 Intervention

MQ710 The dose levels will be escalated following a standard 3+3 dose escalation scheme.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 22Eligibility criteria met