MQ710 + Pembrolizumab for Solid Tumor Cancers

Palo Alto (17 mi)

Overseen byLara Dunn, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

I have had a biopsy to check my condition.

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

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

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

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

Exclusion Criteria

I have a history of chronic liver disease or cirrhosis.

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

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

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

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

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

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

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

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

I have had my spleen removed.

My cancer has spread to my brain or its coverings.

I need blood-thinning medication like warfarin.

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

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

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

Treatment Details

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.

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.