Health TrialsbyHealthPanel

A Study of VET3-TGI in Patients With Solid Tumors

ConditionsSolid Tumor, AdultMicrosatellite Stable Colorectal CancerHead and Neck Squamous Cell CarcinomaCervical CancerKidney CancerRenal Cell CarcinomaMelanoma Stage IVMerkel Cell Carcinoma of SkinMesotheliomaNon-small Cell Lung CancerCutaneous Squamous Cell Carcinoma (CSCC)Urothelial Carcinoma BladderSquamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaliVir Immunotherapeutics

About this trial

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 atezolizumab in patients with solid tumors (STEALTH-001).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VET3-TGI

    Drug

    Oncolytic vaccinia virus engineered with immunomodulatory transgenes

  • Atezolizumab

    Drug

    anti-pd-L1 antibody

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Group A: VET3-TGI alone intratumoralExperimental treatment 1 intervention
Group B: Group B: VET3-TGI intratumoral in combination with atezolizumabExperimental treatment 2 interventions
Group C: Group C: VET3-TGI alone intravenousExperimental treatment 1 intervention
Group D: Group D: VET3-TGI intravenous in combination with atezolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab

Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0

Time frame
108 months
2

Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab

Number of dose limiting toxicities, as defined in the protocol, by dose group

Time frame
4 weeks
3

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 atezolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation

Time frame
4 weeks

Secondary outcomes

1

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

Time frame
108 months
2

Efficacy assessment: Duration of response (DOR)

Median duration of response in patients with a CR or PR

Time frame
108 months
3

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

Time frame
108 months
4

Efficacy assessment: Time to tumor progression (TTP)

Median time until patient disease progression (PD)

Time frame
108 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KaliVir Immunotherapeutics

Lead sponsor

Source ClinicalTrials.gov
Apply now