Adult Solid TumorPhase 1NCT04892043
Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing SQZ-AAC-HPV, Ipilimumab and Nivolumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 6 sites in United States.
Trial summary
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Tumor
- What is being tested?
- SQZ-AAC-HPV, Ipilimumab and Nivolumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Aug 2021to 2 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years of age who are HLA-A*02+ (performed during screening locally or centrally, or based on documented historic test results)
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
- At least 1 measurable lesion according to RECIST 1.1
- Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Baseline and on Cycle 2 Day 8 (+/- 3 days)
- Patients must agree to venous access for the blood collection for manufacture of autologous blood product and be willing to have a central line inserted if venous access is an issue
- Adequate organ function and bone marrow reserve performed within 14 days of blood collection for manufacture of autologous blood product
Who cannot join
- Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to blood collection for manufacture of autologous blood product. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to Cycle 1 Day 1
- Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to Cycle 1 Day 1
- Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the Sponsor
- Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
- Patients with >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to blood collection for manufacture of autologous blood product, except Grade 2 alopecia
- Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
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- History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
- Has known active central nervous system metastases
- History of interstitial lung disease requiring steroids
- Significant acute or chronic illness
- Major surgery within 2 weeks of blood collection for manufacture of autologous blood product
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope Medical Center
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.
- Conditions
- Adult Solid Tumor
- Being tested
- SQZ-AAC-HPV, Ipilimumab, Nivolumab
- Keywords
- solid tumors cancer, metastatic, locally advanced, cancer, cervical, head and neck, anal, penile, SQZ-AAC-HPV, HPV16, AAC, cell therapy, ipilimumab, nivolumab, checkpoint inhibitors, immunotherapy, solid tumor, HLA-A*02, therapeutic vaccine, recurrent cancer
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQZ-AAC-HPVBiological
Activating antigen carriers (AACs) cell therapy; therapeutic vaccine engineered from red blood cells manufactured with immunogenic epitopes of HPV16
IpilimumabDrug
Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
NivolumabDrug
Programmed cell death 1 (PD-1) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Monotherapy Dose Escalation Phase | Experimental | In Part 1, SQZ-AAC-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 1a: low dose SQZ-AAC-HPV
* Cohort 1b: high dose SQZ-AAC-HPV
* Cohort 1c: higher or lower dose SQZ-AAC-HPV Receives: Biological: SQZ-AAC-HPV |
| Part 2 Combination Safety Phase | Experimental | In Part 2, SQZ-AAC-HPV in combination with immune checkpoint inhibitors (1) ipilimumab, (2) nivolumab, or (3) nivolumab plus ipilimumab is administered every 3 weeks up to a year, but the immune checkpoint inhibitors may be administered up to 2 years. There are 3 groups ("Cohorts") in this Phase as follows:
* Cohort 2a: SQZ-AAC-HPV RP2D (Recommended Phase 2 Dose) plus ipilimumab
* Cohort 2b: SQZ-AAC-HPV RP2D plus nivolumab
* Cohort 2c: SQZ-AAC-HPV RP2D plus nivolumab and ipilimumab Receives: Biological: SQZ-AAC-HPV; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
For SQZ-AAC-HPV administered as monotherapy, and in combination with immune checkpoint inhibitors (Part 1 and Part 2, respectively)
Measured: Up to 1 year after LPFV (Last Patient, First Visit)
Number of participants with dose-limiting toxicity (DLT)
For SQZ-AAC-HPV as a monotherapy (Part 1)
Measured: Through Day 28
Number of participants with DLT
For SQC-AAC-HPV in combination with immune checkpoint inhibitors (Part 2)
Measured: Through Day 28
Secondary outcomes (8)
Progression-free survival (PFS)
Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Overall survival (OS)
Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Objective response rate (ORR)
Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Duration of Response (DoR)
Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Best overall Response (BoR)
Evaluation of the BoR defined as CR, PR, Stable Disease [SD], Progressive Disease [PD] or Not Evaluable [NE] as defined by RECIST v1.1 criteria. For SQZ-AAC-HPV as a monotherapy, in combination with immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Disease-control rate (DCR)
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-AAC-HPV as a monotherapy, in combination immune checkpoint inhibitors (Part 1, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Amount of investigational product (IP) from individual patient blood collection - batch yield
To determine manufacturing feasibility as assessed by batch yield (number of manufacturing runs) (Part 1)
Measured: From leukapheresis through manufacture, a maximum of 28 days
Amount of investigational product (IP) from individual patient blood collection - product failures
To determine manufacturing feasibility as assessed by number of product failures (Part 1)
Measured: From leukapheresis through manufacture, a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start19 Aug 2021
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Why it stopped: Corporate Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- SQZ Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892043
- Sponsor's protocol ID
- SQZ-AAC-HPV-101
- Status last verified
- Feb 2024
- First submitted
- 28 Apr 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04892043
- Acronym / sponsor ID
- SQZ-AAC-HPV-101
- Conditions
- Adult Solid Tumor
- Keywords
- solid tumors cancer, metastatic, locally advanced, cancer, cervical, head and neck, anal, penile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate Decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SQZ BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Monotherapy Dose Escalation Phase | Experimental | Biological: SQZ-AAC-HPVIn Part 1, SQZ-AAC-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 1a: low dose SQZ-AAC-HPV * Cohort 1b: high dose SQZ-AAC-HPV * Cohort 1c: higher or lower dose SQZ-AAC-HPV |
| Part 2 Combination Safety Phase | Experimental | Biological: SQZ-AAC-HPV, Drug: Ipilimumab, Drug: NivolumabIn Part 2, SQZ-AAC-HPV in combination with immune checkpoint inhibitors (1) ipilimumab, (2) nivolumab, or (3) nivolumab plus ipilimumab is administered every 3 weeks up to a year, but the immune checkpoint inhibitors may be administered up to 2 years. There are 3 groups ("Cohorts") in this Phase as follows: * Cohort 2a: SQZ-AAC-HPV RP2D (Recommended Phase 2 Dose) plus ipilimumab * Cohort 2b: SQZ-AAC-HPV RP2D plus nivolumab * Cohort 2c: SQZ-AAC-HPV RP2D plus nivolumab and ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients ≥18 years of age who are HLA-A*02+ (performed during screening locally or centrally, or based on documented historic test results)
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
- At least 1 measurable lesion according to RECIST 1.1
Key exclusion criteria (11 listed)
- Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to blood collection for manufacture of autologous blood product. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to Cycle 1 Day 1
- Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to Cycle 1 Day 1
- Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the Sponsor
- Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
- Patients with >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to blood collection for manufacture of autologous blood product, except Grade 2 alopecia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQZ-AAC-HPVActivating antigen carriers (AACs) cell therapy; therapeutic vaccine engineered from red blood cells manufactured with immunogenic epitopes of HPV16 | Biological | Part 1 Monotherapy Dose Escalation Phase, Part 2 Combination Safety Phase |
| IpilimumabCytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody | Drug | Part 2 Combination Safety Phase |
| NivolumabProgrammed cell death 1 (PD-1) blocking antibody | Drug | Part 2 Combination Safety Phase |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
Time frame: Up to 1 year after LPFV (Last Patient, First Visit)
For SQZ-AAC-HPV administered as monotherapy, and in combination with immune checkpoint inhibitors (Part 1 and Part 2, respectively)
Number of participants with dose-limiting toxicity (DLT)
Time frame: Through Day 28
For SQZ-AAC-HPV as a monotherapy (Part 1)
Number of participants with DLT
Time frame: Through Day 28
For SQC-AAC-HPV in combination with immune checkpoint inhibitors (Part 2)
8 secondary outcomes
Progression-free survival (PFS)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Overall survival (OS)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Objective response rate (ORR)
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Duration of Response (DoR)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Best overall Response (BoR)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Disease-control rate (DCR)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Amount of investigational product (IP) from individual patient blood collection - batch yield
Time frame: From leukapheresis through manufacture, a maximum of 28 days
Amount of investigational product (IP) from individual patient blood collection - product failures
Time frame: From leukapheresis through manufacture, a maximum of 28 days
Results and safety
The study was stopped early (reason given: Corporate Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SQZ-AAC-HPV, Ipilimumab and Nivolumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Corporate Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0 (time frame: Up to 1 year after LPFV (Last Patient, First Visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.