SQZ-eAPC-HPV + Pembrolizumab for Solid Cancers

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: SQZ Biotechnologies

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.

Research Team

Eligibility Criteria

Adults with HPV16+ recurrent or metastatic solid tumors, such as head and neck, cervical, anal, vulvar, or penile cancer. Participants must have a measurable lesion for biopsy and not have used immune checkpoint inhibitors before. They should be in good health with proper organ function.

Inclusion Criteria

I have never been treated with immune checkpoint inhibitors.

At least 1 measurable lesion according to RECIST 1.1

My organs and bone marrow are working well, tested within the last 2 weeks.

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Exclusion Criteria

Known hypersensitivity to pembrolizumab

I have been treated with drugs that boost the immune system.

I have cancer that has spread to my brain.

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Treatment Details

Interventions

Pembrolizumab (Checkpoint Inhibitor)
SQZ-eAPC-HPV (CAR T-cell Therapy)

Trial OverviewThe trial is testing SQZ-eAPC-HPV alone and combined with Pembrolizumab to evaluate safety, effectiveness against tumors, and immune response in patients with HPV16+ solid tumors.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Part 2 Lead-in Combination PhaseExperimental Treatment2 Interventions

In Part 2, SQZ-eAPC-HPV will be administered on Day 1 of each treatment cycle. Treatment with 200 mg of pembrolizumab will begin in Cycle 3. Starting at Cycle 3, patients will be administered SQZ-eAPC-HPV and then pembrolizumab every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab.

Group II: Part 1B Combination PhaseExperimental Treatment2 Interventions

In Part 1B, SQZ-eAPC-HPV is administered in combination with immune checkpoint inhibitor pembrolizumab. SQZ-eAPC-HPV will be administered on Day 1 of Cycle 1 and 200 mg of pembrolizumab will be administered on Day 8 of Cycle 1. In future cycles, patients will be first administered SQZ-eAPC-HPV and then pembrolizumab on the first day of each cycle, every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab.

Group III: Part 1A Monotherapy Dose Escalation PhaseExperimental Treatment1 Intervention

In Part 1A, SQZ-eAPC-HPV as a monotherapy is administered every 3 weeks for up to a year. There are 3 groups ("Cohorts") in this Phase as follows: * Cohort 1: low dose SQZ-eAPC-HPV * Cohort 2: intermediate dose SQZ-eAPC-HPV * Cohort 3: high dose SQZ-eAPC-HPV Additional provisional cohorts may be opened prior to starting Part 1B.