Clinical trial NCT06444815: A Study of VET3-TGI in Patients With Solid Tumors
Official title: A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Microsatellite Stable Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Kidney Cancer
Renal Cell Carcinoma
Melanoma Stage IV
Merkel Cell Carcinoma of Skin
Mesothelioma
Non-small Cell Lung Cancer
Lead sponsor: KaliVir Immunotherapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: VET3-TGI was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. This is a Phase 1 dose escalation (and expansion) study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation has 4 groups: the first group (Group A) will determine the highest tolerated dose of VET3-TGI when injected into tumor(s); the second group (Group C) will determine the highest tolerated dose of VET3-TGI when infused into the vein. The third and fourth groups (Group B and D) will combine VET3-TGI with pembrolizumab. These groups will begin at the highest tolerated dose determined in Group B and Group D, respectively.

Once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
timeFrame: 108 months
measure: Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with pembrolizumab
timeFrame: 4 weeks
measure: Determine the recommended Phase 2 dose
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy assessment: overall response rate (ORR)
timeFrame: 108 months
measure: Efficacy assessment: Duration of response (DOR)
timeFrame: 108 months
measure: Efficacy assessment: disease control rate (DCR)
timeFrame: 108 months
measure: Efficacy assessment: Time to tumor progression (TTP)
timeFrame: 108 months
measure: Efficacy assessment: Progression free survival (PFS)
timeFrame: 108 months
measure: Overall survival
timeFrame: 108 months
measure: Immune changes in tissue and blood
timeFrame: 6 weeks
measure: VET3-TGI delivery and replication kinetics
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Pittsburgh
country: United States
facility: UPMC- Hillman Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: