To hear about similar clinical trials, please enter your email below
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