Metastatic CancerPhase 1STARNCT04053283
First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector
A Phase 1 study testing NG-641 in people with Metastatic Cancer and Epithelial Tumor, run by Akamis Bio at 6 sites in United States.
Trial summary
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Epithelial Tumor
- What is being tested?
- NG-641
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jan 2020to 20 Dec 2023
- 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
- Phase 1a:
- Histologically or cytologically documented metastatic or advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available
- All patients
- Provide written informed consent to participate
- At least one measurable site of disease according to RECIST Version 1.1 criteria
- Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
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- Ability to comply with study procedures in the Investigator's opinion
- Aged 18 years or over
- ECOG performance status 0 or 1
- Predicted life expectancy of 6 months or more
- Adequate lung reserve
- Adequate renal function
- Adequate hepatic function
- Adequate bone marrow function
- Meeting reproductive status requirements
Who cannot join
- Prior or planned allogenic or autologous bone marrow or organ transplantation
- Splenectomy
- Active infections requiring antibiotics, physician monitoring or systemic therapy within 1 week of the anticipated first dose of study drug, or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
- Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment
- Known history of hepatitis B infection or known active hepatitis C infection. Known history of HIV infection
- Patients who have active, known or suspected autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving systemic immunosuppressive treatment
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- Treatment with any live, live-attenuated or COVID-19 vaccine in the 28 days before the first dose of NG-641
- Treatment with any vaccine (including known non-adenoviral COVID-19 vaccines) in the 7 days before the first dose of NG-641
- History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment
- History of clinically significant interstitial lung disease or non-infectious pneumonitis
- Lymphangitic carcinomatosis
- Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment
- Any known CTCAE Grade ≥2 coagulation abnormality/coagulopathy
- Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the 6 months before the first dose of study treatment
- Grade 3 or 4 gastrointestinal bleeding All toxicities attributed to prior anti-cancer therapy (including radiation therapy) other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment
- Tumour location/extent considered by the Investigator to present a significant risk if tumour flare or necrosis were to occur
- Known retinopathy, including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction
- Active clinically severe depression
- Use of following prior therapies
- Enadenotucirev-based therapy, or a fibroblast activation protein (FAP) targeting agent anytime
- Anti-cancer monoclonal antibody (mAb), immune checkpoint inhibitor, immune stimulatory treatment or other biological therapy in the 28 days prior to the first dose of study treatment (PD-1 / PD-L1 therapy permitted without a 'washout' phase)
- Chemotherapy, targeted small molecule or other investigational drug in the 14 days or five half-lives (whichever is shorter) before the first dose of study treatment
- Major surgery in the 28 days before the first dose of study treatment or radiation therapy in the 14 days before the first dose of study treatment
- Bisphosphonate therapy or treatment with Receptor Activator of Nuclear factor Kappa-Β (RANK)-ligand inhibitors for metastatic bone disease is permitted
- All toxicities attributed to prior anti-cancer therapy (including radiation therapy) other than alopecia must have resolved to Grade 1 or baseline before the first dose of study treatment
- Known allergy/immune-related adverse reactions to NG-641 transgene or immune checkpoint inhibitor products or formulation; severe hypersensitivity to another monoclonal antibody
- Known hypersensitivity to both cidofovir and valacyclovir
- Other prior malignancy active within the previous 3 years (see protocol for exceptions)
- Symptomatic brain metastases or any leptomeningeal metastases that are symptomatic and/or requires treatment
- Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Moffitt-Advent Health Clinical Research Unit
Celebration, Florida, 34747
MD Anderson
Houston, Texas, 77030
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Ochsner Medical Center (OMC) - The Gayle and Tom Benson Cancer Center
New Orleans, Louisiana, 70121-2429
UCLA
Santa Barbara, California, 93105
Washington University Medical School
St Louis, Missouri, 63110
About this study
Official title: A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
Read the detailed description
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).
- Conditions
- Metastatic Cancer, Epithelial Tumor
- Being tested
- NG-641
- Keywords
- metastatic; epithelial; virus; advanced; PsiOxus
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG-641Biological
NG-641 is a replication competent adenoviral vector producing a bispecific T cell activator (TAc) targeting fibroblast activation protein (FAP) plus immune enhancer genes CXCL9/CXCL10/IFNa2. This can lead to killing of tumor cells and stimulation of immunity against the tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Experimental | Phase 1a dose escalation: one cycle of treatment.
Phase 1a dose optimisation: up to 8 cycles of treatment Receives: Biological: NG-641 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (safety and tolerability) in study NG-641
Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
Measured: End of study treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start23 Jan 2020
- Primary completion31 Aug 2023
- Study completion20 Dec 2023
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 Metastatic CancerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akamis Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053283
- Sponsor's protocol ID
- NG-641-01
- Acronym
- STAR
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2019
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.
PubMed 36897458
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
- ClinicalTrials.gov ID
- NCT04053283
- Acronym / sponsor ID
- STAR / NG-641-01
- Conditions
- Metastatic Cancer, Epithelial Tumor
- Keywords
- metastatic; epithelial; virus; advanced; PsiOxus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Akamis BioIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 12 Aug 2019 (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.
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
Detailed description
To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.
The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Experimental | Biological: NG-641Phase 1a dose escalation: one cycle of treatment. Phase 1a dose optimisation: up to 8 cycles of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically documented metastatic or advanced epithelial cancer that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available
- All patients
- Provide written informed consent to participate
- At least one measurable site of disease according to RECIST Version 1.1 criteria
- Tumour accessible for biopsy, biopsy deemed safe by the Investigator, and patient willing to consent to tumour biopsies
Key exclusion criteria (30 listed)
- Prior or planned allogenic or autologous bone marrow or organ transplantation
- Splenectomy
- Active infections requiring antibiotics, physician monitoring or systemic therapy within 1 week of the anticipated first dose of study drug, or recurrent fevers (>38.0˚C) associated with a clinical diagnosis of active infection
- Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment; or pegylated interferon in the 4 weeks before the first dose of study treatment
- Known history of hepatitis B infection or known active hepatitis C infection. Known history of HIV infection
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 |
|---|---|---|
| NG-641NG-641 is a replication competent adenoviral vector producing a bispecific T cell activator (TAc) targeting fibroblast activation protein (FAP) plus immune enhancer genes CXCL9/CXCL10/IFNa2. This can lead to killing of tumor cells and stimulation of immunity against the tumor cells. | Biological | Intravenous |
Primary outcome
Incidence of adverse events (safety and tolerability) in study NG-641
Time frame: End of study treatment visit
Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 36897458Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 NG-641 in people with Metastatic Cancer and Epithelial Tumor, run by Akamis Bio at 6 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 15 inclusion and 30 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: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (safety and tolerability) in study NG-641 (time frame: End of study treatment visit). 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 NCT04053283, 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 24 Mar 2025.