Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis

NCT06365918 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2023-0836NCI-2024-03236
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors.

Conditions

Advanced Solid Tumor; Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Intraperitoneal VG2025

EXPERIMENTAL

Participants will receive VG2025 intraperitoneally over about 5 minutes on Days 1-3 of each 21-day cycle. Participants will be watched for side effects for about 2 hours after each dose. Up to 3 dose levels of VG2025 will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of VG2025 given intraperitoneally is found.

Drug: VG2025

Interventions

VG2025 DRUG

Given by Intraperitoneal

Intraperitoneal VG2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
• Pathology reviewed at MD Anderson Cancer Center.
• Participants must have evidence of peritoneal carcinomatosis per imaging studies, as well as measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Had an interval of ≥ 4 weeks (28 days) since exposure to immunotherapy, an interval of ≥ 3 weeks (21 days) since exposure to systemic chemotherapy, an interval of ≥ 6 weeks (42 days) since exposure to nitrosourea, and an interval of ≥ 2 weeks (14 days) since exposure to radiotherapy, prior to dosing.
• Participants must also:
• have either disease progression or intolerable toxicity after standard treatment.
• have received at least one prior line of systemic standard therapy.
• be fully recovered or at a grade 1 toxicity (based on CTCAE V5.0) due to prior chemotherapy, immunotherapy, or radiotherapy at Screening.
• Participants must have adequate organ and marrow functions as defined below:
• Hemoglobin ≥ 80 grams (g)/liter (L).
• ANC ≥ 1.0 x 10\^9/L.
• Lymphocyte count ≥ 0.75 x 109/L.

You may not qualify if:

• Participants who are receiving any other investigational agents.
• Participation in any previous trial when the last dose of the investigational agent was received within the last 4 weeks prior to dosing. If the half-life of the investigational drug was less than 5 days, participants may participate in the study sooner after 5 half-lives.
• Participants with any primary CNS malignancy including glioma, or symptomatic and progressing CNS malignant lesions, including leptomeningeal disease are excluded. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (\[MRI or CT scan) during the screening period and off systemic steroids (for at least 2 weeks prior to first dose of VG2025).
• Major surgery within 21 days prior to Screening commencement. Procedures such as Pleural drainage, tumor needle biopsy, feeding tube placement and central venous catheter are not considered major surgery.
• Intercurrent serious infections within 28 days prior to Screening or treated systematically with intravenous antibiotics within 14 days prior to Screening.
• Life-threatening illness unrelated to cancer.
• Active Herpes infection.
• Treatment with antiviral agents within 14 days prior to Screening commencement.
• Known contraindications or hypersensitivity to the excipients of VG2025.
• Participants with congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
• Known to test positive for human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis.
• For participants with positive test results of HIV that meet all the following eligibility criteria may be enrolled:
• Have a T-cell (CD4+) count ≥ 350 cells/uL.
• No History of opportunistic infections or other malignancies.
• Have an HIV viral load less than 400 copies/mL prior to enrollment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Siqing Fu, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: September 30, 2024
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)