GEN2 for Advanced Cancer

Not currently recruiting at 6 trial locations

Overseen By Barbara Metallo

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GenVivo, Inc.

Must not be taking: Oncolytic viruses, Live vaccines

Disqualifiers: CNS tumor, Active infections, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called GEN2 for adults with advanced or metastatic solid tumors that have not responded to other treatments. The study aims to determine the optimal dose of GEN2, administered either through an IV or directly into the tumor. Suitable candidates include those with advanced cancer unresponsive to previous treatments and who can take oral medication. The trial will help researchers understand how GEN2 affects different tumor types and could lead to new options for cancer patients. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires a 'washout period' (time without taking certain medications) of 28 days for any investigational agent or anticancer therapy before starting the study. If you are on antiviral therapy for hepatitis C, you must stop it two weeks before starting the trial. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that GEN2 is being tested for safety and tolerability. In earlier studies, researchers administered GEN2 to patients with solid tumors to identify any harmful side effects. The primary goal was to determine a safe dose for future tests.

As this is an early stage of testing, the treatment is primarily assessed for safety. Researchers closely monitor for any negative reactions or problems. Currently, the focus is on understanding how GEN2 affects patients and ensuring its safety before advancing to more comprehensive tests. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy, radiation, and targeted therapies, GEN2 is unique because it utilizes a novel mechanism of action that specifically targets cancer cell pathways without affecting normal cells. This precision targeting reduces the risk of damaging healthy tissues, potentially leading to fewer side effects. Researchers are excited about GEN2 because it represents a new class of treatment that could offer a more effective and safer option for patients with advanced cancer.

What evidence suggests that GEN2 might be an effective treatment for advanced cancer?

Researchers are investigating GEN2 to determine its potential in treating advanced cancers. In earlier studies, GEN2 showed promise in managing solid tumors. This treatment targets cancer cells directly, which may slow or stop tumor growth. Although human trials have provided limited information, early signs suggest that GEN2 could offer a new approach to cancer treatment. Current research primarily focuses on assessing the safety of GEN2 and determining the correct dosage. Further studies will provide more information about its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have spread locally or to other parts of the body can join this trial. The study is in two parts: first, finding the right dose and then seeing how well it works on different tumor types.

Inclusion Criteria

I can swallow pills.

I am fully active or can carry out light work.

My advanced cancer did not respond or has worsened after previous treatment.

Exclusion Criteria

I haven't taken any experimental cancer treatments in the last 28 days.

I have liver cancer but not active hepatitis B. I may have had hepatitis B or C but am not on antiviral therapy.

Known HIV positivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

GEN2 is administered at increasing dose levels via intravenous infusion or intratumoral injection on Days 1, 3, and 8 every 4 weeks. Valganciclovir starts dosing on Day 12 and continues for 10 days.

4 weeks

Dose Expansion

Further assess intravenous administration of GEN2 in specific tumor types with approximately 15 patients per tumor type.

Variable, based on patient enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease control rate and duration of response.

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• GEN2

Trial Overview The trial tests GEN2, a new drug given by IV on specific days over a 4-week cycle, along with Valganciclovir starting from Day 12. After determining the best dose in up to 50 patients, they'll expand to test more people per tumor type.

Who Is Running the Clinical Trial?

GenVivo, Inc.

Lead Sponsor

Trials

2

Recruited

190+

Published Research Related to This Trial

Crizotinib, an ALK inhibitor, has been established as a new standard of care for advanced ALK-positive non-small cell lung cancer (NSCLC) due to its significant efficacy and favorable safety profile observed in phase I, II, and III trials.

Most adverse events associated with crizotinib are mild to moderate, and with proper monitoring and supportive care, dose interruptions can often be avoided, allowing patients to continue benefiting from the treatment even after initial disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. Cappuzzo, F., Moro-Sibilot, D., Gautschi, O., et al.[2018]

Sunitinib has been shown to be an effective treatment for patients with advanced gastrointestinal stromal tumors (GIST) who are resistant or intolerant to imatinib, with a median overall survival of 16.6 months based on a study of 1124 patients.

The study also highlighted that modifying the initial dosing schedule of sunitinib can lead to significantly longer survival (23.5 months) compared to adhering strictly to the original dosing plan, while the treatment was generally well-tolerated with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Reichardt, P., Kang, YK., Rutkowski, P., et al.[2022]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

Healthcare providers need to be aware of and prepared to handle a new range of adverse reactions that may occur due to innovative cancer therapies.

As cancer treatments evolve, understanding these potential side effects is crucial for ensuring patient safety and effective management of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted cancer. These "smart weapons" hit cancer in novel ways. Held-Warmkessel, J.[2013]

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.

The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. Rong, L., Xie, M., Jiang, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06391918

NCT06391918 | Phase 1 Study of GEN2 in Patients With ... This study includes two parts: dose escalation and dose expansion. In the dose escalation phase, GEN2 will be administered at increasing dose levels via ...

2. withpower.com withpower.com/trial/phase-1-solid-tumors-adult-2-2024-681e4

GEN2 for Advanced Cancer This Phase 1 medical study run by GenVivo, Inc. is evaluating whether GEN2 will have tolerable side effects & efficacy for patients with Solid Tumors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289103/

GAIN2 trial overall survival with intense versus tailored dose ... In GAIN-2, 78.7% of patients treated in the adjuvant setting were node-positive and showed an impressive 4-year OS rate of 92.8% with ...

4. nature.com nature.com/articles/s43018-025-01058-2

Cryoablation plus sintilimab and lenvatinib in advanced or ... The median time to response (TTR) was 3.6 months (95% CI: 2.6–6.2) and the median DOR was 17.0 months (95% CI: 7.9–not reached (NR)). As of the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9489195/

Results of a Phase II Clinical Trial - PMC This single-arm, prospective phase II clinical trial enrolled patients with advanced cancer with an actionable mutation who received MTB- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39481054/

Phase II Trial of Enfortumab Vedotin in Patients With ... EV demonstrated antitumor activity in heavily pretreated HNC. Safety was consistent with the known safety profile of EV; no new safety signals were identified.

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06391918

Phase 1 Study of GEN2 in Patients With Advanced Solid ... The clinical trial is primarily designed to assess the safety and tolerability of GEN2 and to establish the recommended Phase II dose (RP2D). Following the ...

8. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A784

692 COMMANDER-001: safety data from a phase I/II dose ... SQZ-eAPC-HPV is an autologous, HLA agnostic, PBMC cell vaccine targeting HPV16 viral oncoproteins, E6 and E7, using the Cell Squeeze® platform.