Solid Tumor, AdultPhase 1NCT05117177
New Formulation Study of Inupadenant (EOS100850) in Patients with Cancer
A Phase 1 study testing Inupadenant in people with Solid Tumor, Adult, run by iTeos Therapeutics at 5 sites in 2 countries.
Trial summary
A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Inupadenant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2021to 9 May 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
- Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
- At least 4 weeks since any previous treatment for cancer
- Subject must consent to pretreatment and on treatment tumor biopsies
- Adequate organ and marrow function
Who cannot join
- Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
- Participants with second/other active cancers requiring current treatment
- Uncontrolled/significant heart disease
- Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or - - Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
- Active/uncontrolled autoimmune disease
- Active infection
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium4 sites
Institut Jules Bordet
Anderlecht, 1070
Cliniques Universitaires St-Luc
Brussels, Brussels Capital, 1200
University Hospital Ghent
Ghent, Ghent, 9000
GZA Ziekenhuizen
Wilrijk, Antwerpen, 2610
United Kingdom1 site
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulations in Participants with Advanced Solid Tumors
A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.
- Conditions
- Solid Tumor, Adult
- Being tested
- Inupadenant
- Keywords
- Solid Tumor, Advanced Cancers, Phase I, Pharmacokinetics, Safety, Immunotherapy, Adenosine, Inupadenant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InupadenantDrug
Also called EOS100850
Oral administration
InupadenantDrug
Also called EOS100850
Oral administration
InupadenantDrug
Also called EOS100850
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Inupadenant sequential dose escalation (Part 1A) | Experimental | Part 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors. Receives: Drug: Inupadenant |
| Inupadenant randomized crossover (Part 1B) | Experimental | The effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors. Receives: Drug: Inupadenant |
| Inupadenant single treatment assignment (Part 1C) | Experimental | Part 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors. Receives: Drug: Inupadenant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities
Measured: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
Incidence and severity of AEs in patients receiving inupadenant
To assess safety and tolerability as measured by incidence and severity of AEs
Measured: Through study completion, an average of 4 months
Secondary outcomes (6)
Plasma concentration of inupadenant vs. time profiles
Determined by inspection of the concentration-time profile
Measured: Through study completion, an average of 4 months
Maximum observed serum concentration (Cmax)
Determined by inspection of the concentration-time profile
Measured: Through study completion, an average of 4 months
Time of maximum observed concentration (Tmax)
Determined by inspection of the concentration-time profile
Measured: Through study completion, an average of 4 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Determined by inspection of the concentration-time profile
Measured: Through study completion, an average of 4 months
Plasma concentration half-life (T-HALF)
Determined by inspection of the concentration-time profile
Measured: Through study completion, an average of 4 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Assessment of preliminary efficacy of inupadenant
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jul 2021
- Primary completion9 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Responsible party
- Sponsor
- Investigators
- Iteos Clinical Trials, Study director, iTeos Belgium SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117177
- Sponsor's protocol ID
- A2A-004
- Other IDs
- 2020-005861-15
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulations in Participants with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05117177
- Acronym / sponsor ID
- A2A-004
- Conditions
- Solid Tumor, Adult
- Keywords
- Solid Tumor, Advanced Cancers, Phase I, Pharmacokinetics, Safety, Immunotherapy, Adenosine, Inupadenant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 11 Nov 2021 (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.
A2A-004 is a three-part multicenter, open-label, Phase I clinical trial intended to evaluate the safety and tolerability, and the pharmacokinetics (PK) and food effect of new formulations of inupadenant (formerly known as EOS100850), in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Arm 1: sequential dose escalation Arm 2: randomized crossover Arm 3: single treatment assignment
| Arm | Type | Receives |
|---|---|---|
| Inupadenant sequential dose escalation (Part 1A) | Experimental | Drug: InupadenantPart 1A will evaluate the safety as well as to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of inupadenant in participants with advanced solid tumors. |
| Inupadenant randomized crossover (Part 1B) | Experimental | Drug: InupadenantThe effect of food on the exposure to inupadenant will be investigated in participants with advanced solid tumors. |
| Inupadenant single treatment assignment (Part 1C) | Experimental | Drug: InupadenantPart 1C will investigate an additional formulation of inupadenant in participants with advanced solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
- At least 4 weeks since any previous treatment for cancer
- Subject must consent to pretreatment and on treatment tumor biopsies
- Adequate organ and marrow function
Key exclusion criteria (7 listed)
- Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
- Participants with second/other active cancers requiring current treatment
- Uncontrolled/significant heart disease
- Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or - - Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
- Active/uncontrolled autoimmune disease
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 |
|---|---|---|
| InupadenantAlso: EOS100850Oral administration | Drug | Inupadenant sequential dose escalation (Part 1A) |
| InupadenantAlso: EOS100850Oral administration | Drug | Inupadenant randomized crossover (Part 1B) |
| InupadenantAlso: EOS100850Oral administration | Drug | Inupadenant single treatment assignment (Part 1C) |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant
Time frame: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)
Incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, AEs leading to discontinuation, deaths, electrocardiogram (ECG) abnormalities, and clinically significant laboratory abnormalities
Incidence and severity of AEs in patients receiving inupadenant
Time frame: Through study completion, an average of 4 months
To assess safety and tolerability as measured by incidence and severity of AEs
6 secondary outcomes
Plasma concentration of inupadenant vs. time profiles
Time frame: Through study completion, an average of 4 months
Maximum observed serum concentration (Cmax)
Time frame: Through study completion, an average of 4 months
Time of maximum observed concentration (Tmax)
Time frame: Through study completion, an average of 4 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Time frame: Through study completion, an average of 4 months
Plasma concentration half-life (T-HALF)
Time frame: Through study completion, an average of 4 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time frame: Through study completion, an average of 4 months
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 19 Sep 2024.
- 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.
Iteos Clinical Trials study director
iTeos Belgium SA
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inupadenant in people with Solid Tumor, Adult, run by iTeos Therapeutics at 5 sites in 2 countries.
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 5 inclusion and 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, United Kingdom. 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 Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving inupadenant (time frame: During the DLT evaluation period that is cycle 1 (each cycle is 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.