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Tests treatment safety and results for Melanoma (Skin)
Official title START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
ClinicalTrials.gov ID: NCT05492682
What this study is testing
What is PeptiCRAd-1?
PeptiCRAd-1 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for melanoma (skin).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Inoperable/metastatic cutaneous malignant melanoma
- Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- Inoperable/metastatic cutaneous malignant melanoma
- Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC
- Inoperable advanced/metastatic non-squamous NSCLC
- 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...
- 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
- 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.
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen.
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt, Germany
- Heidelberg, Germany
- Tübingen, Germany
- Candiolo, Italy
- Milan, Italy
- Naples, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt, Germany; Heidelberg, Germany; Tübingen, Germany; Candiolo, Italy; Milan, Italy; Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.