A Study of VET3-TGI in Patients With Solid Tumors (STEALTH-001)

KaliVir Immunotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Merkel Cell Carcinoma of Skin; Melanoma Stage IV; Solid Tumor, Adult; Non-small Cell Lung Cancer; Kidney Cancer; Mesothelioma; Renal Cell Carcinoma; Microsatellite Stable Colorectal Cancer; Cervical Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: VET3-TGI; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06444815

STEALTH-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 4 patient groups

Group A: VET3-TGI alone intratumoral

Experimental group

Description:

Dose escalation of VET3-TGI alone administered by direct injection into tumor(s) x 4. Booster injections of VET3-TGI are permitted for up to 2 years.

Treatment:

Drug: VET3-TGI

Group B: VET3-TGI intratumoral in combination with pembrolizumab

Experimental group

Description:

VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group A. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.

Treatment:

Drug: Pembrolizumab

Drug: VET3-TGI

Group C: VET3-TGI alone intravenous

Experimental group

Description:

Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.

Treatment:

Drug: VET3-TGI

Group D: VET3-TGI intravenous in combination with pembrolizumab

Experimental group

Description:

VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group C. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.

Treatment:

Drug: Pembrolizumab

Drug: VET3-TGI