Patients With Advanced Solid TumorsPhase 1ICVB-1042NCT05904236
Safety and Tolerability of Intravenous Administration of ICVB-1042
A Phase 1 study testing Treatment with ICVB-1042 administered intravenously in people with Patients With Advanced Solid Tumors, run by IconOVir Bio at 10 sites in United States.
Trial summary
Study to evaluate the safety and tolerability of intravenous ICVB-1042 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- Treatment with ICVB-1042 administered intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jun 2023to 20 Dec 2024
- 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 relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present
- Measurable disease according to RECIST v1.1
- ECOG Performance Status 0 or 1
- Life expectancy of at least 3 months
Who cannot join
- Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy
- Major surgical procedures within 28 days prior to dosing
- Limited field irradiation for palliation within 14 days prior to dosing
- Anti-viral agents, vaccinations within 28 days prior to dosing
- Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days
- Leptomeningeal carcinomatosis
Show all 14Show fewer
- Pulmonary lymphangitic spread of cancer
- History of clinically significant cardiovascular abnormalities
- Known active infection requiring systemic antibiotic therapy or systemic antifungal therapy
- Known active HIV, hepatitis B or C, or other active viral disease
- Known hematologic malignancies (requiring or not requiring active therapy).
- Requirement for immunosuppressive therapy (ie, prednisone equivalent of >10 mg/day)
- Women who are pregnant or lactating
- Oxygen saturation measured with Pulse oximeter <90% and/or on supplemental O2
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Karmanos Cancer Institute
Detroit, Michigan, 48201
Next Oncology, Virginia
Fairfax, Virginia, 22031
Carolina BioOncology
Huntersville, North Carolina, 28078
Next Oncology, Dallas
Irving, Texas, 75039
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
NYU Langone Health, Perlmutter Cancer Center
New York, New York, 10016
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Next Oncology, San Antonio
San Antonio, Texas, 78229
California Cancer Associates
San Marcos, California, 92069
About this study
Official title: Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors
Study to evaluate the safety and tolerability of intravenous ICVB-1042
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- Treatment with ICVB-1042 administered intravenously
- Keywords
- Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with ICVB-1042 administered intravenouslyDrug
Part A Dose Escalation to assess safety and tolerability of ascending dose levels, define the maximum tolerated dose (MTD), and expansion dose(s) Part B Dose Expansion to further assess safety and tolerability of 1 or more dose levels
| Study group | Role | What they receive |
|---|---|---|
| ICVB-1042 | Experimental | Part A: Dose escalation Part B: Dose expansion Receives: Drug: Treatment with ICVB-1042 administered intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intravenous ICVB-1042
Assessment of treatment-emergent dose limiting toxicity
Measured: From dose administration through 12 weeks
Secondary outcomes (2)
Concentration profile of ICVB-1042 in plasma
Measured: Up to 48 hours after drug infusion
Determine immunogenicity of ICVB-1042
Assessment of anti-drug antibody titer
Measured: From dose administration through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2023
- Primary completion11 Dec 2024
- Study completion20 Dec 2024
Why it stopped: Lack of Demonstrated Clinical Activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Escalating doses
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- IconOVir Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Maltzman, MD, Study director, IconOVir Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904236
- Sponsor's protocol ID
- 1042-CLN01
- Acronym
- ICVB-1042
- Status last verified
- Apr 2025
- First submitted
- 23 May 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kato Y, Rice N, Pokrass M, Jeong J, Rodriguez R, Field JJ, Nowyhed H. Nonclinical characterization of ICVB-1042 as a selective oncolytic adenovirus for solid tumor treatment. Commun Biol. 2024 Sep 13;7(1):1132. doi: 10.1038/s42003-024-06839-6.
PubMed 39271928
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05904236
- Acronym / sponsor ID
- ICVB-1042 / 1042-CLN01
- Conditions
- Patients With Advanced Solid Tumors
- Keywords
- Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Demonstrated Clinical Activity
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IconOVir BioIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety and tolerability of intravenous ICVB-1042
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Escalating doses
| Arm | Type | Receives |
|---|---|---|
| ICVB-1042 | Experimental | Drug: Treatment with ICVB-1042 administered intravenouslyPart A: Dose escalation Part B: Dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present
- Measurable disease according to RECIST v1.1
- ECOG Performance Status 0 or 1
- Life expectancy of at least 3 months
Key exclusion criteria (14 listed)
- Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy
- Major surgical procedures within 28 days prior to dosing
- Limited field irradiation for palliation within 14 days prior to dosing
- Anti-viral agents, vaccinations within 28 days prior to dosing
- Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with ICVB-1042 administered intravenouslyPart A Dose Escalation to assess safety and tolerability of ascending dose levels, define the maximum tolerated dose (MTD), and expansion dose(s) Part B Dose Expansion to further assess safety and tolerability of 1 or more dose levels | Drug | ICVB-1042 |
Primary outcome
Safety of intravenous ICVB-1042
Time frame: From dose administration through 12 weeks
Assessment of treatment-emergent dose limiting toxicity
2 secondary outcomes
Concentration profile of ICVB-1042 in plasma
Time frame: Up to 48 hours after drug infusion
Determine immunogenicity of ICVB-1042
Time frame: From dose administration through 12 weeks
Results and safety
The study was stopped early (reason given: Lack of Demonstrated Clinical Activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 39271928Kato Y, Rice N, Pokrass M, Jeong J, Rodriguez R, Field JJ, Nowyhed H. Nonclinical characterization of ICVB-1042 as a selective oncolytic adenovirus for solid tumor treatment. Commun Biol. 2024 Sep 13;7(1):1132. doi: 10.1038/s42003-024-06839-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Maltzman, MD study director
IconOVir Bio
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment with ICVB-1042 administered intravenously in people with Patients With Advanced Solid Tumors, run by IconOVir Bio at 10 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 4 inclusion and 14 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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: Lack of Demonstrated Clinical Activity). 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?
Safety of intravenous ICVB-1042 (time frame: From dose administration through 12 weeks). 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 NCT05904236, which also lists 1 linked publication.
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 8 Apr 2025.