Melanoma (Skin)Phase 1NCT05492682
START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
A Phase 1 study testing PeptiCRAd-1, Cyclophosphamide and Pembrolizumab in people with Melanoma (Skin) and Triple-Negative Breast Cancer, run by Valo Therapeutics Oy at 7 sites in 2 countries.
Trial summary
This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Triple-Negative Breast Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- PeptiCRAd-1, Cyclophosphamide and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 2 Feb 2023to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Written informed consent.
- Male or female, ≥18 years of age.
- Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy:
- Inoperable/metastatic cutaneous malignant melanoma
- Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC
- Inoperable advanced/metastatic non-squamous NSCLC
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- Inoperable and/or advanced Synovial or myxoid round cell sarcoma
- Inoperable and/or advanced osteosarcoma
- Inoperable and/or advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline
- Inoperable and/or advanced/metastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Tumor lesion which is deemed feasible for biopsy and injection
- ECOG/WHO performance status 0 to 1.
- Acceptable liver and renal function, defined as:
- Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and
- Serum creatinine ≤1.5 x ULN
- Acceptable hematological function, defined as:
- Hemoglobin ≥9 g/dL, and
- Neutrophils ≥1.5 x 109/L, and
- Platelet count ≥100 x 109/L Patients may be transfused to meet the hemoglobin entry criteria.
- Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal.
- Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period.
- Urine pregnancy tests should have a sensitivity of at least 25 mIU/mL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood.
- Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment
Who cannot join
- Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.
- Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.
- Prior or concomitant radiotherapy within 4 weeks before Day 1.
- Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.
- Active bacterial, viral, or fungal infection that requires systemic therapy.
- Active autoimmune disease that has required systemic treatment in the past two years.
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- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.
- Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.
- Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.
- Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.
- Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.
- Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:
- Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1
- Grade 2 or higher pneumonitis
- Grade 4 AST or ALT elevation
- Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.
- History of or planned tissue / organ transplant.
- Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.
- Unwillingness or inability to comply with the study protocol for any reason.
- Admission to an institution by virtue of an order issued by the judicial or administrative authorities.
- Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and/or involved directly in the study.
- Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Italy4 sites, 4 recruiting
- Recruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
Candiolo
Vanesa Gregorc, vanesa.gregorc@ircc.it
- Not yet recruiting
IRCCS Istituto Clinico Humanitas
Milan
Matteo Simonelli, matteo.simonelli@hunimed.eu
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan
Gianluca Del Conte, delconte.gianluca@hsr.it
- Not yet recruiting
Università di Napoli Federico II
Naples
Roberto Bianco, robianco@unina.it
Germany3 sites
- Active, not recruiting
Krankenhaus Nordwest
Frankfurt
- Completed
National Center for Tumor Diseases
Heidelberg
- Completed
Universitätsklinikum Tübingen
Tübingen
About this study
Official title: A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3
This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.
Read the detailed description
This is a Phase I, open-label, non-randomized, first-in-human study. All patients will be pre-treated with a low dose of intravenous (i.v.) Cyclophosphamide (CPO) followed by monotherapy doses of PeptiCRAd-1. PeptiCRAd-1 will be administered by intratumoral (i.t.) injection (Cohort 1) and by i.t. and subcutaneous (s.c.) injection (Cohort 2) followed by combination therapy with PeptiCRAd-1 and i.v. CPI (pembrolizumab).
- Conditions
- Melanoma (Skin), Triple-Negative Breast Cancer, Non-Small Cell Lung Cancer, Synovial Sarcoma, Myxoid Liposarcoma, Colorectal Cancer
- Being tested
- PeptiCRAd-1, Cyclophosphamide, Pembrolizumab
- Medical subject headings
- Melanoma, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Sarcoma, Synovial, Liposarcoma, Myxoid, Colorectal Neoplasms, Osteosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeptiCRAd-1Drug
All patients will receive PeptiCRAd-1.
CyclophosphamideDrug
All patients will be pre-treated with one single dose of Cyclophosphamide.
PembrolizumabDrug
All patients will receive 6 doses of Pembrolizumab within the study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients in Cohort 1 are treated with PeptiCRAd-1 administered i.t. Receives: Drug: PeptiCRAd-1; Drug: Cyclophosphamide; Drug: Pembrolizumab |
| Cohort 2 | Experimental | Patients in Cohort 2 are treated with PeptiCRAd-1 administered i.t. and s.c. Receives: Drug: PeptiCRAd-1; Drug: Cyclophosphamide; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy.
The incidence and characteristics of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs) will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 monotherapy in order to evaluate the safety and tolerability.
Measured: From study protocol day 1 (baseline) until 1 month
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 and CPI combination.
The incidence and characteristics of TEAEs, SAEs and DLTs will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 and CPI combination in order to evaluate the safety and tolerability.
Measured: From first month through study completion, an average of 4.5 months.
Secondary outcomes (6)
Measurement of New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) and Melanoma-associated antigen 3 (MAGE A3) specific T-cells in peripheral blood.
Presence vs. no presence of cellular immune response.
Measured: Change from Baseline through study completion, an average of 5 months.
Measurement of NY-ESO-1 and MAGE A3 antibodies in serum.
Presence vs. no presence of humoral response.
Measured: Change from Baseline to an average of 3,5 months
To determine the number of tumor infiltrating lymphocytes (TILs) in tumor mass.
Number of TILs in tumor biopsies.
Measured: Change from Baseline to an average of 3 months
To determine objective response rate (ORR).
Objective responses according to RECIST 1.1, iRECIST, itRECIST and PERCIST 1.0.
Measured: Change from Baseline through study completion, an average of 5 months.
To determine overall survival.
Overall survival presented in Kaplan-Meier plot.
Measured: Change from Baseline through study completion, an average of 5 months.
Correlation between immune activation in peripheral blood and tumor mass and clinical outcome.
Correlation between immune activation (immunological variables) in peripheral blood and tumor mass and clinical outcome (ORR, OS).
Measured: Change from Baseline through study completion, an average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start2 Feb 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valo Therapeutics Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492682
- Sponsor's protocol ID
- VALO-001
- Other IDs
- 2021-002529-13
- Status last verified
- May 2026
- First submitted
- 18 May 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3
- ClinicalTrials.gov ID
- NCT05492682
- Acronym / sponsor ID
- VALO-001
- Conditions
- Melanoma (Skin), Triple-Negative Breast Cancer, Non-Small Cell Lung Cancer, Synovial Sarcoma, Myxoid Liposarcoma, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Valo Therapeutics OyIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Aug 2022 (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 study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.
Detailed description
This is a Phase I, open-label, non-randomized, first-in-human study. All patients will be pre-treated with a low dose of intravenous (i.v.) Cyclophosphamide (CPO) followed by monotherapy doses of PeptiCRAd-1. PeptiCRAd-1 will be administered by intratumoral (i.t.) injection (Cohort 1) and by i.t. and subcutaneous (s.c.) injection (Cohort 2) followed by combination therapy with PeptiCRAd-1 and i.v. CPI (pembrolizumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PeptiCRAd-1, Drug: Cyclophosphamide, Drug: PembrolizumabPatients in Cohort 1 are treated with PeptiCRAd-1 administered i.t. |
| Cohort 2 | Experimental | Drug: PeptiCRAd-1, Drug: Cyclophosphamide, Drug: PembrolizumabPatients in Cohort 2 are treated with PeptiCRAd-1 administered i.t. and s.c. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent.
- Male or female, ≥18 years of age.
- Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy:
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Tumor lesion which is deemed feasible for biopsy and injection
Key exclusion criteria (22 listed)
- Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.
- Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.
- Prior or concomitant radiotherapy within 4 weeks before Day 1.
- Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.
- Active bacterial, viral, or fungal infection that requires systemic 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 |
|---|---|---|
| PeptiCRAd-1All patients will receive PeptiCRAd-1. | Drug | Cohort 1, Cohort 2 |
| CyclophosphamideAll patients will be pre-treated with one single dose of Cyclophosphamide. | Drug | Cohort 1, Cohort 2 |
| PembrolizumabAll patients will receive 6 doses of Pembrolizumab within the study. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy.
Time frame: From study protocol day 1 (baseline) until 1 month
The incidence and characteristics of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs) will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 monotherapy in order to evaluate the safety and tolerability.
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 and CPI combination.
Time frame: From first month through study completion, an average of 4.5 months.
The incidence and characteristics of TEAEs, SAEs and DLTs will be assessed by CTCAE version 5.0 and changes from baseline in assessed safety parameters (Hematology tests, Clinical Chemistry safety tests, urine analysis ECOG/WHO performance status, vital signs) are measured in patients receiving PeptiCRAd-1 and CPI combination in order to evaluate the safety and tolerability.
6 secondary outcomes
Measurement of New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) and Melanoma-associated antigen 3 (MAGE A3) specific T-cells in peripheral blood.
Time frame: Change from Baseline through study completion, an average of 5 months.
Measurement of NY-ESO-1 and MAGE A3 antibodies in serum.
Time frame: Change from Baseline to an average of 3,5 months
To determine the number of tumor infiltrating lymphocytes (TILs) in tumor mass.
Time frame: Change from Baseline to an average of 3 months
To determine objective response rate (ORR).
Time frame: Change from Baseline through study completion, an average of 5 months.
To determine overall survival.
Time frame: Change from Baseline through study completion, an average of 5 months.
Correlation between immune activation in peripheral blood and tumor mass and clinical outcome.
Time frame: Change from Baseline through study completion, an average of 5 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PeptiCRAd-1, Cyclophosphamide and Pembrolizumab in people with Melanoma (Skin) and Triple-Negative Breast Cancer, run by Valo Therapeutics Oy at 7 sites in 2 countries.
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 25 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuryk, PhD (0505876088 ext. 358, info@valotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy. (time frame: From study protocol day 1 (baseline) until 1 month). The study lists 2 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 12 May 2026.