START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer (NCT05492682) | Clinical Trial Compass
Active — Not RecruitingPhase 1
START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
Germany15 participantsStarted 2023-02-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 therapy:
✓. 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:
✓. Acceptable hematological function, defined as:
Exclusion criteria
✕. 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.
What they're measuring
1
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.
Timeframe: From study protocol day 1 (baseline) until 1 month
2
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.
Timeframe: From first month through study completion, an average of 4.5 months.
✕. 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 biopsies.