Intravenous ICVB-1042 for Pain

(ICVB-1042 Trial)

No longer recruiting at 9 trial locations

Overseen By IconOVir Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: IconOVir Bio

Must not be taking: Antivirals, Vaccines, Steroids, others

Disqualifiers: CNS metastases, Cardiovascular abnormalities, Infections, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ICVB-1042, administered intravenously, to determine its safety and tolerability for people with advanced solid tumors unresponsive to other treatments. The focus is on identifying the right dose to help manage pain. This trial may suit adults whose cancer has progressed despite other therapies, including specific treatments targeting their cancer type. For those whose cancer continues to grow after other treatments, this trial could be an option. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had certain treatments like biologics, major surgeries, or anti-viral agents within a specific time before starting the trial. 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?

Earlier studies tested ICVB-1042 on mice and found it to be well tolerated, meaning it did not cause major side effects. Compared to another virus treatment (HAdV-C5), ICVB-1042 showed less accumulation in the liver, suggesting it might be safer for the body overall. This is promising because it implies that the treatment might also be gentle on the liver in humans. However, since the current trial is in an early stage, the main goal is to assess its safety for people. Early-stage trials primarily focus on safety, closely monitoring for any side effects. More detailed human safety data will be available later this year. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ICVB-1042 is unique because it is delivered intravenously, which can provide rapid pain relief compared to traditional oral medications. Researchers are excited about this treatment because it offers a new approach by potentially targeting pain pathways more directly and effectively. This method may reduce the need for higher doses often required in oral medications, potentially leading to fewer side effects and better pain management for patients.

What evidence suggests that ICVB-1042 might be an effective treatment for pain?

Research has shown that ICVB-1042, the investigational treatment in this trial, has potential based on early studies. Tests with mice demonstrated that it helped shrink tumors, suggesting it could be an effective treatment. The drug targets specific processes related to pain and tumor growth. These early findings are encouraging and support further research into its use for pain relief. Although limited information exists from human studies, the drug's mechanism suggests it could be effective. ^{1 2 6 7 8}

Who Is on the Research Team?

Julie Maltzman, MD

Principal Investigator

IconOVir Bio

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have worsened after treatment, including immune therapies and targeted drugs. Participants must have measurable disease, be relatively active (ECOG 0 or 1), and expected to live at least 3 more months. It's not for those who've had recent major surgery, significant heart issues, active infections needing strong meds, HIV/hepatitis B/C, blood cancers, need high-dose steroids or are pregnant/breastfeeding.

Inclusion Criteria

My cancer has returned or didn't respond to treatment, including immunotherapy and targeted therapy.

I am fully active or can carry out light work.

Life expectancy of at least 3 months

Exclusion Criteria

I haven't had any vaccines or antiviral drugs in the last 28 days.

I am taking more than 10 mg/day of prednisone or a similar medication.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous administration of ICVB-1042 with dose escalation and expansion

12 weeks

Visits on Day 1, Day 10, Day 29, Day 57, Day 85 or Early Termination visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ICVB-1042

Trial Overview

The study tests the safety of a new drug called ICVB-1042 given through the veins to people with certain types of tumors. The main goal is to see how well patients tolerate this drug and what doses are safe.

How Is the Trial Designed?

Group I: ICVB-1042 Experimental Treatment 1 Intervention

Part A: Dose escalation Part B: Dose expansion

Who Is Running the Clinical Trial?

IconOVir Bio

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

ABT-102, a selective TRPV1 antagonist, demonstrated effective pharmacokinetics in healthy volunteers across three phase 1 studies, showing dose- and time-linear behavior with a half-life of 7 to 11 hours.

The studies confirmed that ABT-102 reaches steady state by day 5 of dosing, with a robust pharmacokinetic model indicating effective absorption and elimination, which is crucial for its potential use in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of the TRPV1 antagonist ABT-102 in healthy human volunteers: population analysis of data from 3 phase 1 trials. Othman, AA., Nothaft, W., Awni, WM., et al.[2013]

Intravenous ibuprofen (IVIB) at doses of 400 mg and 800 mg significantly reduced morphine consumption and improved pain relief in patients after abdominal or orthopedic surgery compared to a placebo, without increasing adverse events.

Both doses of IVIB provided similar analgesic effects and patient satisfaction scores, indicating that either dose can be effectively used for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Efficacy of Intravenous Ibuprofen in the Treatment of Postoperative Acute Pain: A Phase III Multicenter Randomized Placebo-ControlledDouble-Blind Clinical Trial. Zhou, HS., Li, TT., Pi, Y., et al.[2023]

In a study of 81 cancer patients experiencing severe pain, some patients developed a hyperexcited state that worsened with increasing doses of intravenous morphine, indicating a potential for opioid-induced hyperalgesia.

Switching from intravenous morphine to intravenous methadone was successful in managing pain for patients who did not respond to morphine, suggesting that methadone may be a viable alternative in cases of opioid-induced complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-induced hyperalgesia after rapid titration with intravenous morphine: Switching and re-titration to intravenous methadone. Mercadante, S., Ferrera, P., Arcuri, E., et al.[2015]

The multi-injection intertransverse process block provided non-inferior pain relief compared to the thoracic paravertebral block within 30 minutes after major breast cancer surgery, with similar worst resting pain scores.

Both techniques resulted in comparable recovery quality 24 hours post-surgery, indicating that the intertransverse process block is an effective alternative for managing postoperative pain in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between ultrasound-guided multi-injection intertransverse process and thoracic paravertebral blocks for major breast cancer surgery: a randomized non-inferiority trial. Zhang, H., Qu, Z., Miao, Y., et al.[2023]

In a study of 90 patients with multiple rib fractures, thoracic paravertebral block (TPVB) provided significantly better pain relief compared to intravenous patient-controlled analgesia (IVPCA), as indicated by lower visual analogue scale (VAS) scores during rest and coughing.

TPVB also resulted in better preservation of pulmonary function, with higher oxygen levels and lung capacity measurements, and fewer complications compared to IVPCA, highlighting its efficacy in managing both pain and respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic paravertebral block versus intravenous patient-controlled analgesia for pain treatment in patients with multiple rib fractures. Yeying, G., Liyong, Y., Yuebo, C., et al.[2018]

Two novel compounds, A-686085 and A-1048400, effectively block N-type and T-type calcium channels, showing potential for pain relief without significant side effects; A-1048400 is particularly notable for not affecting blood pressure.

A-1048400 demonstrated robust pain relief in various pain models without altering psychomotor or hemodynamic functions, suggesting it could be a safer alternative for treating chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A-1048400 is a novel, orally active, state-dependent neuronal calcium channel blocker that produces dose-dependent antinociception without altering hemodynamic function in rats. Scott, VE., Vortherms, TA., Niforatos, W., et al.[2011]

BIBN 4096 BS, a new CGRP receptor antagonist for acute migraine treatment, demonstrated a favorable safety profile in a study involving 55 healthy volunteers, with no serious adverse events reported and only mild, transient side effects like paresthesias and fatigue.

The pharmacokinetics of BIBN 4096 BS showed dose-proportional plasma concentration increases, with a terminal half-life of approximately 2.5 hours, indicating effective dosing and clearance characteristics that support its potential use in migraine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability and pharmacokinetics of BIBN 4096 BS, the first selective small molecule calcitonin gene-related peptide receptor antagonist, following single intravenous administration in healthy volunteers. Iovino, M., Feifel, U., Yong, CL., et al.[2021]

Transdermal buprenorphine (TDB) demonstrated effective pain relief in dogs, with significant increases in thermal pain thresholds lasting beyond 36 hours after application, indicating its potential for long-term pain management.

In a study involving 10 healthy Beagles, TDB achieved peak plasma concentrations of buprenorphine, although some dogs showed no measurable levels, suggesting variability in absorption or metabolism among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antinociceptive efficacy and plasma concentrations of transdermal buprenorphine in dogs. Pieper, K., Schuster, T., Levionnois, O., et al.[2013]

In a randomized controlled trial involving 48 patients undergoing video-assisted thoracoscopic surgery, continuous paravertebral (PV) catheter infusions significantly reduced maximum pain scores compared to single-shot intercostal blocks (ICB) during the 24 to 48 hours post-surgery (3.65 vs 6.44).

Patients receiving the PV catheter reported higher satisfaction with their pain management (74% satisfaction) compared to those with ICB (44% satisfaction), and they also used significantly less opioids (14.39 mg vs 30.50 mg morphine equivalents).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Paravertebral Catheter Versus Intercostal Blocks for Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Trial. Hutchins, J., Sanchez, J., Andrade, R., et al.[2018]

Intercostal nerve block (ICNB) provides significant immediate pain relief for patients with fractured ribs, as shown by a retrospective analysis of medical records, but its effectiveness diminishes over time.

For sustained pain management, especially in patients whose pain levels rise after ICNB, additional methods like intravenous patient-controlled analgesia or fentanyl patches are recommended to prevent complications and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of intercostal nerve block for management of pain in rib fracture patients. Hwang, EG., Lee, Y.[2022]

Cinobufagin (CBG), a compound isolated from Venenum Bufonis (VB), demonstrated stronger analgesic effects in pain tests compared to VB, indicating its potential as a more effective pain reliever.

CBG showed significantly less hepatotoxicity than VB, as evidenced by lower serum AST levels, while both compounds increased heart rate; however, CBG had a higher acute toxicity profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic and toxic effects of venenum bufonis and its constituent compound cinobufagin: A comparative study. Xu, L., Wang, S., Shen, H., et al.[2020]

In a study of 50 patients undergoing video-assisted thoracic surgery (VATS), the continuous intercostal nerve block (ICB) using two catheters provided pain relief that was not significantly different from the paravertebral block (PVB) at 24 hours post-surgery, indicating comparable efficacy.

However, the study could not confirm that ICB is noninferior to PVB, suggesting that further improvements in ICB techniques may be needed for it to serve as a reliable alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the analgesic effects of modified continuous intercostal block and paravertebral block under surgeon's direct vision after video-assisted thoracic surgery: a randomized clinical trial. Kadomatsu, Y., Mori, S., Ueno, H., et al.[2019]

In a study involving six dogs, ABT-116, a TRPV1 antagonist, did not consistently increase pain thresholds compared to buprenorphine, which showed greater analgesic efficacy in both thermal and mechanical pain assessments.

ABT-116 administration led to a significant increase in rectal temperature, indicating a potential side effect, while buprenorphine was more effective in providing pain relief without such temperature changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the analgesic efficacy of oral ABT-116 administration with that of transmucosal buprenorphine administration in dogs. Niyom, S., Mama, KR., De Rezende, ML.[2013]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39271928/

Nonclinical characterization of ICVB-1042 as a selective ...

ICVB-1042 administered to mice intravenously or intratumorally was effective in reducing tumor burden. Its intravenous administration also ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05904236/safety-and-tolerability-of-intravenous-administration-of-icvb-1042?state=NC&city=Huntersville

Safety and Tolerability of Intravenous Administration ...

Study to evaluate the safety and tolerability of intravenous ICVB-1042.

3.

synapse.patsnap.com

synapse.patsnap.com/drug/575e90e02e254f638702259e6522ba0d

ICVB-1042 - Drug Targets, Indications, Patents

ICVB-1042 administered to mice intravenously or intratumorally was effective in reducing tumor burden. Its intravenous administration also inhibited tumor ...

4.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05904236?keyword=%22Refractory%20Solid%20Tumor%22

San Mateo Clinical Trial Safety and Tolerability ...

Study to evaluate the safety and tolerability of intravenous ICVB-1042. Criteria: Source: IconOVir Bio. StartDate: 2023-05-24. Date Last Changed:.

5.

withpower.com

withpower.com/clinical-trials/near-huntersville-nc?page=6

Top Clinical Trials near Huntersville, NC | Power

Intravenous ICVB-1042 for Pain. Huntersville, North Carolina. Study to evaluate the safety and tolerability of intravenous ICVB-1042. No Placebo Group. Trial ...

6.

clin.larvol.com

clin.larvol.com/trial-detail/NCT05904236

NCT05904236

Safety and Tolerability of Intravenous Administration of ICVB-1042. P1 ... 'We look forward to reporting initial safety data later this year, with ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11399272/

Nonclinical characterization of ICVB-1042 as a selective ...

ICVB-1042 was well tolerated in mice compared to HAdV-C5 (Wt Ad5), with reduced liver sequestration, supporting safety of the drug for systemic ...

8.

iconovir.com

iconovir.com/iconovir-bio-announces-first-patient-dosed-in-phase-1-clinical-trial-of-its-lead-product-candidate-icvb-1042/

IconOVir Bio Announces First Patient Dosed in Phase 1 ...

ICVB-1042 is an oncolytic adenovirus for the treatment of advanced solid tumors — — Initial safety data expected in 2H 2023, ...