An Open-Label, Multicenter, Phase I Study of RP3 as a Single Agent and in Combination With PD-1 Blockade in Patients With Solid Tumors.
Study Identifier:
RP3-301
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Recruitment Complete
Considering participating in a START clinical trial?
Study Summary
This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for whom there is no standard therapy preferred to enrollment in a clinical study
- All patients must consent to provide archival tumor biopsy samples within 12 months, or a fresh tumor biopsy is needed. Patients must also consent to provide on treatment biopsies as per protocol
- At least one measurable tumor > or = 1 cm in longest diameter (or shortest diameter for lymph nodes)
- At least one injectable tumor > or = 1 cm in longest diameter or injectable tumors which in aggregate are > or = 1 cm in longest diameter (or shortest diameter for lymph nodes
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Note: Predefined inclusion criteria may apply for each additional expansion cohort.
- confirmed advanced or metastatic non-neurological solid tumors, at least one measurable tumor > or = 1 cm and injectable tumors > or = 1 cm in aggregate, ECOG < or = 1, and adequate hematologic, hepatic, and renal function. In Cohorts 1, 2, and 4, approximately 50% of the pts with lung, breast, and GI cancer must have liver lesions intended for injection.
Exclusion criteria
- Prior treatment with an oncolytic virus therapy
- History of viral infections according to the protocol
- Systemic infection requiring intravenous (IV) antibiotics
- Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis)
- Requires intermittent or chronic use of systemic antivirals
- a. Hepatocellular carcinoma patients with a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment . Hepatocellular carcinoma patients with a history of or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis
- History of interstitial lung disease
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Additional Exclusion Criteria for Patients Enrolled in Part 2 (Expansion Cohorts):
- History of life-threatening toxicity related to prior immune treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Treatment with botanical preparations within 2 weeks prior to treatment.
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- History of interstitial lung disease.
- Severe hypersensitivity to another monoclonal antibody.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received a live vaccine within 28 days prior to the first dose of study treatment.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- History of myocarditis or congestive heart failure within 6 months of screening.
- Has a serious or uncontrolled medical disorder.
- Has a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 480 msec, except for right bundle branch block.
- Exclusion criteria include prior oncolytic virus treatment, need for immunosuppressive therapy, an autoimmune disease requiring systemic therapy, active significant herpetic infections or prior complications of HSV-1 infection, active or chronic HBV or HCV infection, known HIV infection, or prior active malignancy within 3 years.
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.
Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Irene Moreno
Status
Recruitment Complete
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Pancreas
Melanoma
Gastric
Liver
Head & Neck
Solid Tumor
Esophageal
Metastatic Cancer