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Trial Title: START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

NCT ID: NCT05492682

Condition: Melanoma (Skin)
Triple-Negative Breast Cancer
Non-Small Cell Lung Cancer
Synovial Sarcoma
Myxoid Liposarcoma
Colorectal Cancer

Conditions: Official terms:
Triple Negative Breast Neoplasms
Liposarcoma
Sarcoma, Synovial
Liposarcoma, Myxoid
Cyclophosphamide
Pembrolizumab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PeptiCRAd-1
Description: All patients will receive 6 doses of PeptiCRAd-1.
Arm group label: open label non-randomized

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: All patients will be pre-treated with one single dose of Cyclophosphamide.
Arm group label: open label non-randomized

Intervention type: Drug
Intervention name: Pembrolizumab
Description: All patients will receive 6 doses of Pembrolizumab within the study.
Arm group label: open label non-randomized

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.

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. Patients will receive a total of 6 doses of PeptiCRAd-1 during the study. PeptiCRAd-1 will be administered by intratumoral (i.t.) injection with priming doses administered on Days 1, 4, and 8, and the first booster dose on Day 15, followed by combination therapy with PeptiCRAd-1 and i.v. CPI (pembrolizumab).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Written informed consent. 2. Male or female, ≥18 years of age. 3. 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 - Inoperable and/or advanced Synovial or myxoid round cell sarcoma - Inoperable and/or advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. Tumor lesion which is deemed feasible for biopsy and injection 6. ECOG/WHO performance status 0 to 1. 7. 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 8. Acceptable hematological function, defined as: - Hemoglobin ≥10 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. 9. 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. 10. 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. 11. 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 Exclusion Criteria: 1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1. 2. 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. 3. Prior or concomitant radiotherapy within 4 weeks before Day 1. 4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1. 5. Active bacterial, viral, or fungal infection that requires systemic therapy. 6. Active autoimmune disease that has required systemic treatment in the past two years. 7. 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. 8. 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. 9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis. 10. 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. 11. 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. 12. History of or planned tissue / organ transplant. 13. 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. 14. Unwillingness or inability to comply with the study protocol for any reason. 15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities. 16. 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. 17. 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Krankenhaus Nordwest

Address:
City: Frankfurt
Country: Germany

Status: Recruiting

Facility:
Name: National Center for Tumor Diseases

Address:
City: Heidelberg
Country: Germany

Status: Recruiting

Facility:
Name: Universitätsklinikum Tübingen

Address:
City: Tübingen
Country: Germany

Status: Recruiting

Start date: February 2, 2023

Completion date: September 2025

Lead sponsor:
Agency: Valo Therapeutics Oy
Agency class: Industry

Source: Valo Therapeutics Oy

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05492682

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