Colorectal Cancer MetastaticPhase 2NCT05243862
Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
A Phase 2 study testing PolyPEPI1018 and Atezolizumab in people with Colorectal Cancer Metastatic, run by Treos Bio Limited at 3 sites in United States.
Trial summary
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- PolyPEPI1018 and Atezolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jun 2022to 14 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide written informed consent for the trial.
- Adults 18 years or older on the day of signing informed consent.
- Histologically or cytologically confirmed CRC that is metastatic.
- Primary and/or metastatic tumor(s) that is known to be MSS as determined locally
- Must have had 2-3 prior lines of therapy for CRC in the advanced or metastatic setting, including all of the following in the absence of contraindications: a) fluoropyrimidine, b) oxaliplatin, c) irinotecan, d) one or more biologics depending on the clinical scenario. Prior regorafenib and/or TAS-102 are allowed but not required. Note: a line of therapy is generally considered >2 weeks of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g. 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.
- Willingness to undergo biopsy prior to study therapy and after approximately 6 weeks of study therapy. If biopsy on study is not feasible, then archival tissue must be available from within 90 days of signing consent.
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- Willingness to undergo buccal swab prior to study therapy for the determination of HLA profile.
- Documented radiographic progression after the last regimen prior to entry on this study.
- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate organ functions as defined by the following laboratory parameters at baseline (laboratory parameters outside of these ranges that are deemed clinically insignificant should be discussed with the medical monitor):
- Absolute neutrophil count ≥1.5 x 109/L;
- Hemoglobin ≥9 g/dL: transfusion to achieve this cutoff is not allowed within 14 days of first dose of study therapy;
- Platelet count ≥100,000/mm3;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) - ASL and/or ALT may be ≤5 x ULN in the setting of liver metastases;
- Total bilirubin ≤ 1.5 x institutional ULN;
- Serum creatinine within normal limits or calculated creatinine clearance >60 mL/min/1.73 m2 using the Cockroft-Gault method (Appendix 2) for participants with serum creatinine levels above or below the institutional normal range;
- Albumin ≥3.0 g/dL;
- Acceptable coagulation parameters including international normalized ratio (INR) <1.5 and partial thromboplastin time (PTT) ≤ institutional ULN in the absence of anticoagulation (participant on anticoagulants must be discussed with the medical monitor).
- Has no major existing comorbidities or medical conditions that will preclude therapy in the view of the investigator.
- Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v 5.0) of all clinically significant toxic effects of prior therapies (with exception of peripheral neuropathy).
- Female participants are eligible to participate if at the time of screening are not pregnant, not breastfeeding, and at least one of the following conditions applies: (a) Not a woman of childbearing potential (WOCBP); or (b) WOCBP who (i) agrees to use highly effective contraception starting with the screening visit through 90 days after the last dose of study treatment; and (ii) must have a negative urine or serum pregnancy test within 72 hours prior to receiving any dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Childbearing potential is defined by at least one of the following: (a) ≥50 years of age and has not had menses for greater than 1 year; (b) amenorrheic for ≥2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation; (c) has had hysterectomy, bilateral oophorectomy or tubal ligation.
- Highly effective contraception is defined in Appendix 3 or per national or local guidelines.
- Abstinence is acceptable if this is the established and preferred method of contraception/lifestyle of the participant.
- Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraception throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received by the male participant. Male participants with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
- Abstinence is acceptable if this is the established and preferred method of contraception of the participant.
Who cannot join
- Prior treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other checkpoint inhibitors.
- Has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 28 days of the first dose of study therapy or 5 half-lives (whichever is shorter) if at least 10 days have elapsed between the last dose of such agents and the first dose of study therapy. NOTE: Patients who have been given palliative radiotherapy to peripheral sites (e.g., bone metastases) may enroll before 28 days have elapsed if they have recovered from any acute toxicities.
- Has received a live vaccine within 28 days of the first dose of study therapy.
- Has had major surgical procedure, open biopsy or significant traumatic injury within 28 days of the first dose of study therapy.
- Participating in another research study involving receipt of an investigational product 21 days prior to study therapy.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are also eligible for this study.
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- Receiving systemic corticosteroids within one week prior to the first dose of study therapy. Exceptions: corticosteroid use as a premedication for intravenous (IV) contrast, intermittent corticosteroid use (e.g., daily prednisone at doses of ≤10 mg or equivalent), bronchodilators, inhaled steroids, or local steroid injections (except at the proposed injection site of PolyPEPI1018) are acceptable.
- History of anaphylaxis in relation to vaccination or the administration of a protein product.
- Has known allergy to any component of the study treatment formulation(s).
- Has symptomatic interstitial lung disease (ILD) or ILD which may interfere with detection and management of new immune-related pulmonary toxicity.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Has known, active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with previously treated, stable CNS metastases may participate if (a) there is no evidence of progression by imaging [magnetic resonance imaging (MRI) or computed tomography (CT) as used during the prior imaging] at least 28 days prior to the first dose of study therapy; (b) resolution or return to baseline of neurologic symptoms; and (c) no requirement for steroids to manage symptoms of brain metastases for at least 28 days prior to first dose of study therapy.
- Active infection requiring systemic therapy.
- Significant liver cirrhosis defined as Child-Pugh Class B or C (Appendix 4).
- Active infection with human immunodeficiency virus (HIV) except participants who are currently stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART during study therapy, have HIV viral load of <400 copies per milliliter (/mL) at screening (or undetectable per local criteria), and have CD4 T cell counts ≥200/microliter.
- Active hepatitis B (HBV) or C (HCV) infection. For participants with evidence of HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. For participants with HCV, infection must have been treated and cured or participants are currently on treatment and have an undetectable HCV viral load.
- History or evidence of cardiovascular disease, chronic respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder or any other medical or psychiatric condition that in the opinion of the investigator will significantly increase the safety risk for the subject or confound the interpretation of the study data.
- Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of study treatment.
- History of another active malignancy that has required therapy within 2 years prior to first dose of study therapy, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, prostate cancer or in situ cervical cancer that has undergone potentially curative therapy or is felt by the investigator to be at low risk for recurrence is allowed.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
- In the opinion of the investigator, participant has rapidly progressing disease, OR has life expectancy <3 months, OR would be unable to receive at least one study treatment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
Read the detailed description
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens. Both agents will be administered on an every-3-week schedule until documented progression. A Simon's 2-stage design will be used for the initial assessment of efficacy.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- PolyPEPI1018, Atezolizumab
- Keywords
- MSS, Peptide Vaccine, Cancer vaccine, PolyPEPI1018, Checkpoint inhibitor, PD-L1 inhibitor, Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyPEPI1018Drug
Also called PolyPEPI1018 CRC vaccine
PolyPEPI1018 vaccine contains 6 synthetic peptides emulsified with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 dominant epitopes from 7 tumor-specific antigens, which are the most frequently expressed antigens in colorectal cancer.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1.
| Study group | Role | What they receive |
|---|---|---|
| PolyPEPI1018 plus Atezolizumab | Experimental | Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection. Receives: Drug: PolyPEPI1018; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence and Severity Treatment Related Adverse Events
The incidence and severity [according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (v5.0)] of all Treatment-Emergent Adverse Events (TEAEs), related TEAEs, all SAEs, and related SAEs
Measured: From 1st dose until 90-Days after last dose, up to 7.5 months.
Clinical Laboratory Safety
Number of patients with clinically meaningful differences observed with respect to group mean laboratory values over time
Measured: From baseline to end of study, up to 12 months.
Administration Safety
Number and proportion of participants with any clinically significant change in vital signs (i.e., blood pressure, pulse rate, respiratory rate, body temperature) during the vaccine administration or within 60 minutes following administration
Measured: From the start of each vaccine administration through 60 minutes after completion of each administration.
Secondary outcomes (7)
Objective Response Rate Assessment
By computed tomography (CT) scan or other appropriate radiographic imaging at Screening Visit and at specified intervals on study therapy by the investigator and per RECIST 1.1
Measured: From study entry up to 2 years
Duration of Response Assessment
DoR from the first demonstration of response per RECIST 1.1 to the first demonstration of radiographic progression per RECIST 1.1
Measured: From study entry up to 3 years
Progression Free Survival Assessment
PFS time from the first dose of study therapy to radiographic progression or death from any cause
Measured: From date of first dose of study therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival Assesment
OS time from the first dose of study therapy to death from any cause
Measured: From first dose of study therapy to death from any cause assessed up to 24 months
PEPI Listing
List number of PEPIs identified by PEPI Test, where PEPIs are personal epitopes based on human leukocyte antigen (HLA)-genotype likely capable of inducing T-cell responses.
Measured: 1 year
Measured Effector T Cell Immune Response
Effector T cell response against vaccine antigens as measured by ex vivo interferon (IFN)-gamma Enzyme-Linked ImmunoSpot (ex vivo ELISPOT) assay at baseline and at specified intervals on study therapy. The Baseline was the most recent non-missing value obtained immediately prior to administration of the first dose, and Post-treatment (on-treatment) was the maximum of the non-missing results obtained after admininstration of the first dose.
Measured: From study entry to last administration, assessed up to 2 years
Measured Memory T Cell Immune Response
Memory T cell response against vaccine antigens of PolyPEPI1018 as measured by in vitro stimulated interferon (IFN)-gamma Enzyme-Linked ImmunoSpot (IVS ELISPOT) assay at baseline and at specified intervals on study therapy. The Baseline is the most recent non-missing value obtained immediately prior to administration of the first dose, and Post-treatment (on-treatment) is the maximum of the non-missing results obtained after admininstration of the first dose.
Measured: From study entry to last administration, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start2 Jun 2022
- Primary completion8 Jul 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal Cancer MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Following the Simon's 2-stage design, 18 participants will be enrolled in the first stage. If no participant with a response is observed, the study will be terminated for futility. If ≥ 1 participants achieve a response, then the study can proceed to the second stage, and additional 10 participants will be enrolled to the second stage.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treos Bio Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Joleen Hubbard, MD, Principal investigator, Mayo ClinicHagop Youssoufian, MD, Study director, Treos Bio Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243862
- Sponsor's protocol ID
- OBERTO-301
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2022
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT05243862
- Acronym / sponsor ID
- OBERTO-301
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- MSS, Peptide Vaccine, Cancer vaccine, PolyPEPI1018, Checkpoint inhibitor, PD-L1 inhibitor, Atezolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Treos Bio LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Hoffmann-La Roche
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 7 Aug 2026
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 multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
Detailed description
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens. Both agents will be administered on an every-3-week schedule until documented progression. A Simon's 2-stage design will be used for the initial assessment of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Following the Simon's 2-stage design, 18 participants will be enrolled in the first stage. If no participant with a response is observed, the study will be terminated for futility. If ≥ 1 participants achieve a response, then the study can proceed to the second stage, and additional 10 participants will be enrolled to the second stage.
| Arm | Type | Receives |
|---|---|---|
| PolyPEPI1018 plus Atezolizumab | Experimental | Drug: PolyPEPI1018, Drug: AtezolizumabParticipants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Provide written informed consent for the trial.
- Adults 18 years or older on the day of signing informed consent.
- Histologically or cytologically confirmed CRC that is metastatic.
- Primary and/or metastatic tumor(s) that is known to be MSS as determined locally
- Must have had 2-3 prior lines of therapy for CRC in the advanced or metastatic setting, including all of the following in the absence of contraindications: a) fluoropyrimidine, b) oxaliplatin, c) irinotecan, d) one or more biologics depending on the clinical scenario. Prior regorafenib and/or TAS-102 are allowed but not required. Note: a line of therapy is generally considered >2 weeks of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g. 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.
Key exclusion criteria (21 listed)
- Prior treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other checkpoint inhibitors.
- Has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 28 days of the first dose of study therapy or 5 half-lives (whichever is shorter) if at least 10 days have elapsed between the last dose of such agents and the first dose of study therapy. NOTE: Patients who have been given palliative radiotherapy to peripheral sites (e.g., bone metastases) may enroll before 28 days have elapsed if they have recovered from any acute toxicities.
- Has received a live vaccine within 28 days of the first dose of study therapy.
- Has had major surgical procedure, open biopsy or significant traumatic injury within 28 days of the first dose of study therapy.
- Participating in another research study involving receipt of an investigational product 21 days prior to study therapy.
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 |
|---|---|---|
| PolyPEPI1018Also: PolyPEPI1018 CRC vaccinePolyPEPI1018 vaccine contains 6 synthetic peptides emulsified with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 dominant epitopes from 7 tumor-specific antigens, which are the most frequently expressed antigens in colorectal cancer. | Drug | PolyPEPI1018 plus Atezolizumab |
| AtezolizumabAlso: TecentriqAtezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1. | Drug | PolyPEPI1018 plus Atezolizumab |
Primary outcome
The Incidence and Severity Treatment Related Adverse Events
Time frame: From 1st dose until 90-Days after last dose, up to 7.5 months.
The incidence and severity [according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (v5.0)] of all Treatment-Emergent Adverse Events (TEAEs), related TEAEs, all SAEs, and related SAEs
Clinical Laboratory Safety
Time frame: From baseline to end of study, up to 12 months.
Number of patients with clinically meaningful differences observed with respect to group mean laboratory values over time
Administration Safety
Time frame: From the start of each vaccine administration through 60 minutes after completion of each administration.
Number and proportion of participants with any clinically significant change in vital signs (i.e., blood pressure, pulse rate, respiratory rate, body temperature) during the vaccine administration or within 60 minutes following administration
7 secondary outcomes
Objective Response Rate Assessment
Time frame: From study entry up to 2 years
Duration of Response Assessment
Time frame: From study entry up to 3 years
Progression Free Survival Assessment
Time frame: From date of first dose of study therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival Assesment
Time frame: From first dose of study therapy to death from any cause assessed up to 24 months
PEPI Listing
Time frame: 1 year
Measured Effector T Cell Immune Response
Time frame: From study entry to last administration, assessed up to 2 years
Measured Memory T Cell Immune Response
Time frame: From study entry to last administration, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Evaluation of safety, immunogenicity and preliminary efficacy of PolyPEPI1018 vaccine in subjects with metastatic colorectal cancer (mCRC) with a predictive biomarkerLink provided by the sponsor.
- P329 PolyPEPI1018 off-the shelf vaccine as add-on to maintenance therapy achieved durable treatment responses in patients with microsatellite-stable metastatic colorectal cancer patients (MSS mCRC)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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CRC
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.
Joleen Hubbard, MD principal investigator
Mayo Clinic
Hagop Youssoufian, MD study director
Treos Bio Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PolyPEPI1018 and Atezolizumab in people with Colorectal Cancer Metastatic, run by Treos Bio Limited at 3 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 27 inclusion and 21 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence and Severity Treatment Related Adverse Events (time frame: From 1st dose until 90-Days after last dose, up to 7.5 months.). 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 7 Aug 2026.