AzTrials
AzTrials

Solid Tumor, AdultPhase 1NCT06391918

Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors

A Phase 1 study testing GEN2 + Valganciclovir in people with Solid Tumor, Adult, run by GenVivo, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. This study includes two parts: dose escalation and dose expansion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
GEN2 + Valganciclovir
How many people
37 participants
Where
7 sitesUnited States
Study dates
4 Mar 2024to 1 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with a locally advanced or metastatic solid tumor that has progressed or was non-responsive to prior therapy
  • Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1.
  • For patients with HCC: Child-Pugh Class A
  • Available archived tumor tissue sample or a lesion that can be safely biopsied if the archived sample is not available.
Show all 11Show fewer
  • Adequate renal, liver and bone marrow function.
  • Ability to swallow VGCV tablets.
  • Willingness of men and women of child-bearing potential (WCBP) to observe conventional and highly effective birth control for the duration of treatment and for 12 months following the last dose of study treatment. Patients who are pregnant or lactating are excluded.
  • For the dose expansion phase: Patients with hepatocellular carcinoma or cutaneous malignancy: no more than 2 prior systemic regimens for metastatic disease. Patients with breast cancer: no more than 2 prior cytotoxic regimens for metastatic disease (single-agent hormone therapy or hormone-based doublets do not count). Patients with cutaneous malignancies includes patients with melanoma, cutaneous squamous cell carcinoma, basal cell carcinoma and Merkel cell carcinoma.
  • For the intratumoral injection dose escalation phase: patients with cutaneous malignancy, including patients with melanoma, cutaneous squamous cell carcinoma, basal cell carcinoma and Merkel cell carcinoma. Patients must have at least 1 measurable and injectable lesion and an additional site of measurable distant metastases for assessment of systemic immune response to therapy. Patients may not have received prior treatment with oncolytic therapy. Patients for whom tyrosine kinase inhibitor therapy would be considered standard of care should have received these agents prior to enrollment in this trial. Patients may not have a history of significant bleeding diathesis.

Who cannot join

  • Investigational agent or anticancer therapy within 28 days or 5 elimination half-lives prior to Cycle 1 Day 1.
  • Prior receipt of talimogene laherparepvec (TVEC) or any other oncolytic virus (including but not limited to RP1, RP2, or BNT111).; prior receipt of a live vaccine within 28 days prior to Cycle 1 Day 1.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of enrollment (alopecia and other nonacute toxicities are not exclusionary)
  • Washout from prior major surgery and radiotherapy (less than 28 days)
  • Symptomatic primary central nervous system (CNS) tumor or metastases; symptomatic leptomeningeal carcinomatosis; untreated spinal cord compression. Patients with CNS lesions may be eligible if CNS lesions are asymptomatic or if neurological symptoms are stable, the patient is not receiving steroids to manage CNS symptoms, and no CNS surgery or radiation has been performed for 28 days (14 days for stereotactic radiation).
  • Active uncontrolled systemic bacterial, viral, or fungal infection, which in the opinion of the Investigator makes it undesirable for the patient to participate in the trial
Show all 11Show fewer
  • Clinically significant active malabsorption syndrome or other conditions such as refractory nausea and vomiting, external biliary shunt, or significant bowel resection likely to affect gastrointestinal absorption of valganciclovir
  • Known contraindications to the ganciclovir class
  • For patients with hepatocellular carcinoma, patients with active hepatitis B are excluded; patients with evidence of prior exposure who have a negative hepatitis surface antigen (HbsAg) and who do not require antiviral therapy are allowed. Patients with hepatitis C are allowed but may not be on antiviral therapy during study participation and for two weeks prior to Cycle 1 Day 1.
  • Known HIV positivity
  • Current treatment with systemic steroids at or above 10 mg/day of prednisone (or its equivalent). Inhalational and topical steroids are acceptable

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • City of Hope

    Duarte, California, 91010

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

  • University of Southern California-Keck School of Medicine

    Los Angeles, California, 90033

  • UCLA Hematology-Oncology

    Los Angeles, California, 90095

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Phase 1 Study of GEN2 in Adult Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. This study includes two parts: dose escalation and dose expansion. In the dose escalation phase, GEN2 will be administered at increasing dose levels via intravenous infusion or intratumoral injection on Days 1, 3 and 8 every 4 weeks. Valganciclovir will start dosing on Day 12 and continue for 10 days (through Day 21). Once a recommended dose has been defined in approximately 35-45 patients, the dose expansion phase will initiate to further assess intravenous administration of GEN2 in specific tumor types. Approximately 15 patients per tumor type will be enrolled in the intravenous dose expansion phase.

Read the detailed description

GEN2 is a non-replicating off-the-shelf gene therapy vector product being developed as a cancer immunotherapy to activate a patient's immune system against their personal cancer antigens (neoantigens). The vector payload encodes for a suicide gene, an enhanced viral thymidine kinase enzyme (HSV-eTK), which in the presence of a prodrug, valganciclovir, causes the tumor to release patient specific tumor antigens. These neoantigens in the presence of a human immune modulator cytokine, granulocyte-macrophage colony-stimulating factor (hGM-CSF), results in the generation of immune effector cells. These effector cells maintain continually amplifying therapeutic immune responses as more tumor cells are killed and release antigen and will potentially kill any new tumor metastases that arise.

Being tested
GEN2 + Valganciclovir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEN2 + ValganciclovirBiological

    Gene therapy vector product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the recommended phase 2 dose (RP2D) of GEN2 by intravenous infusion and intratumoral injection.

    The RP2D will be determined by evaluating the number of subjects with treatment related adverse events and Dose Limiting Toxicities

    Measured: First 28 days.

Secondary outcomes (9)

  1. Safety and tolerability as assessed by adverse event monitoring

    Adverse events as characterized by type, frequency, severity (graded by NCI CTCAE v 5.0), timing, seriousness and relationship to study therapy

    Measured: Up to 24 months

  2. Pharmacokinetics (PK) - Intravenous Administration Cohorts Only: area under the concentration-time curve from the time of dosing to 48 hours after dosing (AUC48h)

    AUC48h will be recorded from the PK plasma samples collected

    Measured: Up to 24 months

  3. PK - Intravenous Administration Cohorts Only: Maximum Concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 24 months

  4. To assess replication competent retrovirus (RCR) in peripheral blood mononuclear cells (PBMCs)

    Measured: Up to 36 months

  5. To assess vector integration into genomic deoxyribonucleic acid (DNA) of PBMCs

    Measured: Up to 36 months

  6. Overall response rate (ORR) by RECIST 1.1 (Response Evaluation in Solid Tumors Version 1.1) by Investigator Review

    ORR is defined as the proportion of participants whose best overall response with confirmation status is rated as (confirmed or unconfirmed) complete response (CR) or (confirmed or unconfirmed) partial response (PR) based on RECIST v1.1.

    Measured: Up to 24 months

  7. Disease control rate including a best overall response of Complete Response (CR), Partial Response (PR) or stable disease (SD)

    DCR is defined as the proportion of participants whose best overall response with confirmation status is rated as (confirmed or unconfirmed) CR, (confirmed or unconfirmed) PR or stable disease (SD) based on RECIST v1.1.

    Measured: Up to 24 months

  8. Duration of response (DOR)

    DOR is measured from the day the criteria are first met for time point overall response rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression per RECIST v1.1 or death in the absence of progression.

    Measured: Up to 24 months

  9. Assess the immunogenicity of GEN2

    Serial blood samples will be screened for anti-vector antibodies (AVAs) and neutralizing antibodies

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start4 Mar 2024
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

Why it stopped: Sponsor strategic business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391918
Sponsor's protocol ID
Protocol GVO-1102
Status last verified
Mar 2026
First submitted
19 Apr 2024
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEN2 + Valganciclovir in people with Solid Tumor, Adult, run by GenVivo, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor strategic business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the recommended phase 2 dose (RP2D) of GEN2 by intravenous infusion and intratumoral injection. (time frame: First 28 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06391918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT06391918 | AzTrials