GEN2 for Advanced Cancer

Recruiting at 4 trial locations

Overseen By James Chrisman

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

124 Participants Needed

Trial Summary

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.

What safety data exists for molecular target anticancer drugs like GEN2?

Molecular target anticancer drugs, which may include treatments like GEN2, have been associated with an increased risk of serious and fatal adverse events compared to placebo. However, these drugs are generally considered safe when monitored properly, as most adverse events are mild to moderate and can be managed with appropriate care. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: an expert consensus. [2018]

2. England 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. [2023]

3. India 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Targeted cancer. These "smart weapons" hit cancer in novel ways. [2013]

5. United States 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. [2022]