Non-small Cell Lung Cancer Clinical Trial
— STEALTH-001Official title:
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with pembrolizumab in patients with solid tumors (STEALTH-001).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2027 |
Est. primary completion date | September 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma. - Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy - Measurable disease as per RECIST 1.1 criteria - At least one tumor amenable to safe ITu injections and/or biopsies - ECOG performance status 0 or 1 - Demonstrate adequate organ function - Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions Additional Inclusion criteria exist Key Exclusion Criteria: - Prior systemic therapy washout (dependent upon the therapy) - Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections. - CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated. - Prior history of myocarditis - Known HIV/AIDS, active HBV or HCV infection. - Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc). Additional Exclusion criteria exist |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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KaliVir Immunotherapeutics |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab | Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0 | 108 months | |
Primary | Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with pembrolizumab | Number of dose limiting toxicities, as defined in the protocol, by dose group | 4 weeks | |
Primary | Determine the recommended Phase 2 dose | he highest dose of VET3-TGI in each group that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation | 4 weeks | |
Secondary | Efficacy assessment: overall response rate (ORR) | The number and proportion of patients with a partial response (PR) or complete response (CR) on imaging by RECIST 1.1 | 108 months | |
Secondary | Efficacy assessment: Duration of response (DOR) | Median duration of response in patients with a CR or PR | 108 months | |
Secondary | Efficacy assessment: disease control rate (DCR) | The number and proportion of patients with stable disease (SD), or a partial response (PR) or complete response (CR) on imaging by RECIST 1.1 | 108 months | |
Secondary | Efficacy assessment: Time to tumor progression (TTP) | Median time until patient disease progression (PD) | 108 months | |
Secondary | Efficacy assessment: Progression free survival (PFS) | Median duration of progression free survival of subjects | 108 months | |
Secondary | Overall survival | median duration of survival across all subjects | 108 months | |
Secondary | Immune changes in tissue and blood | number of subject tissue samples with immune cell infiltrates and heat map changes in the molecular signature of tissue samples | 6 weeks | |
Secondary | VET3-TGI delivery and replication kinetics | Number of subject tissues with positive VET3-TGI gene signatures denoting delivery and complete replication of VET3-TGI | 6 weeks |
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