Actively Recruiting
START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
Led by Valo Therapeutics Oy · Updated on 2026-05-12
15
Participants Needed
7
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Male or female aged 18 years or older.
- Have a histologically confirmed diagnosis of one of the following tumors and qualify for new or continued checkpoint inhibitor therapy: inoperable/metastatic melanoma, relapsed or advanced triple-negative breast cancer, advanced non-squamous non-small cell lung cancer, advanced synovial or myxoid round cell sarcoma, advanced osteosarcoma, advanced colorectal cancer with NY-ESO-1 or MAGE-A3 expression, or advanced/metastatic sarcoma with NY-ESO-1 or MAGE-A3 expression.
- Have measurable disease according to RECIST 1.1 criteria.
- Have a tumor lesion suitable for biopsy and injection.
- Have an ECOG/WHO performance status of 0 or 1.
- Have acceptable liver and kidney function (bilirubin, AST, ALT, creatinine within specified limits).
- Have acceptable blood counts (hemoglobin ≥9 g/dL, neutrophils ≥1.5 x10^9/L, platelet count ≥100 x10^9/L).
- Have acceptable blood clotting function (INR, prothrombin time, and aPTT within 1.5 times the upper limit of normal).
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and after the study per protocol.
- Prior checkpoint inhibitor therapy allowed with a 6-week washout period before starting the study.
You will not qualify if you...
- Received oncolytic virus treatment or live virus vaccine within 4 weeks before study start.
- Use of significant immunosuppressive medications, including high-dose corticosteroids, within 4 weeks before study start.
- Prior or concurrent radiotherapy within 4 weeks before study start.
- Participation in another investigational drug or device study within 4 weeks prior to study start.
- Active bacterial, viral, or fungal infection needing systemic treatment.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Any medical condition that may interfere with study participation or pose unacceptable risk.
- Need for therapeutic anticoagulation that cannot be safely paused for tumor biopsies and injections.
- Known infection with HIV, hepatitis B or C, or active tuberculosis.
- Active central nervous system metastases (except stable asymptomatic brain metastases).
- Prior severe adverse reaction to anti-PD1 or PDL1 therapies.
- History of or planned organ or tissue transplant.
- Pregnant or breastfeeding women or those planning pregnancy during the study; men planning to father children during the study.
- Unable or unwilling to comply with study requirements.
- Institutionalized by judicial or administrative order.
- Employees of the sponsor, investigator site, or directly supervised staff involved in the study.
- Prior or concurrent malignancy that may interfere with safety or efficacy assessments.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Krankenhaus Nordwest
Frankfurt, Germany
Active, Not Recruiting
2
National Center for Tumor Diseases
Heidelberg, Germany
Completed
3
Universitätsklinikum Tübingen
Tübingen, Germany
Completed
4
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
Candiolo, Italy
Actively Recruiting
5
IRCCS Istituto Clinico Humanitas
Milan, Italy
Not Yet Recruiting
6
IRCCS Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
7
Università di Napoli Federico II
Naples, Italy
Not Yet Recruiting
Research Team
K
Kuryk, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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