Solid Tumor, AdultPhase 1IO-001NCT03873883
First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
A Phase 1 study testing EOS100850, Pembrolizumab and Chemotherapy in people with Solid Tumor, Adult, run by iTeos Therapeutics at 19 sites in 6 countries.
Trial summary
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with… 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?
- EOS100850, Pembrolizumab and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 5 Feb 2019to 28 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
19 sites in 6 countries.
19 sites in 6 countries
Belgium4 sites
Institut Jules Bordet
Anderlecht, Brussels Capital, 1070
UCL Saint-Luc
Brussels, Brussels Capital, 1200
UZ Ghent
Ghent, East-Flanders, 9000
Hospital GZA Sint-Augustinus
Wilrijk, Antwerpen, 2610
France4 sites
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, 69008
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie- Pôle Régional de Cancérologie
Poitiers, 86021
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, 44805
Gustave Roussy
Villejuif, 94805
Spain4 sites
Hospital del Mar
Barcelona, 08003
START Madrid-HM CIOCC Hospital Universitario HM Sanchinarro
Madrid, 28050
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, 31008
Onkologikoa
San Sebastián, 20014
United States3 sites
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Karmanos Cancer Institute
Michigan Center, Michigan, 48201
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
South Korea3 sites
Yonsei University Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
St Mary's Hospital, The Catholic University of Korea
Seoul, 06591
United Kingdom1 site
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
Sutton, SM2 5PT
About this study
Official title: Phase I/Ib First-in-Human Study of EOS100850 (Inupadenant) As a Single Agent and in Combination with Pembrolizumab And/or Chemotherapy in Participants with Advanced Cancers
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
- Conditions
- Solid Tumor, Adult
- Being tested
- EOS100850, Pembrolizumab, Chemotherapy
- Keywords
- solid, tumor, advanced cancers, pharmacokinetics, safety, inupadenant, pembrolizumab, chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS100850Drug
Also called Inupadenant
Oral administration
PembrolizumabDrug
Also called Keytruda, MK-3475
IV Infusion
ChemotherapyDrug
Also called carboplatin and paclitaxel
Standard of Care IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| 1A Dose escalation EOS100850 | Experimental | Dose Escalation- EOS100850 Monotherapy: to confirm RP2D Receives: Drug: EOS100850 |
| 1B Dose escalation EOS100850 and Pembrolizumab | Experimental | EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination Receives: Drug: EOS100850; Drug: Pembrolizumab |
| 2A Dose Expansion- EOS100850 | Experimental | Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy Receives: Drug: EOS100850 |
| 2B Dose Expansion - EOS100850 and Pembrolizumab | Experimental | Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients Receives: Drug: EOS100850; Drug: Pembrolizumab |
| 2D Dose expansion - EOS100850 and Chemotherapy in TNBC | Experimental | Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC Receives: Drug: EOS100850; Drug: Chemotherapy |
| 3 EOS100850 in BMK-H participants | Experimental | Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer Receives: Drug: EOS100850 |
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 EOS100850
To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850
Measured: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)
Incidence and severity of AEs in patients receiving EOS100850
To assess safety and tolerability as measured by incidence and severity of AEs
Measured: Up to 30 months
Secondary outcomes (6)
Plasma concentration of EOS100850 vs. time profiles
Determined by inspection of the concentration-time profile
Measured: Up to 30 months
Maximum observed serum concentration (Cmax)
Determined by inspection of the concentration-time profile
Measured: Up to 30 months
Time of maximum observed concentration (Tmax)
Determined by inspection of the concentration-time profile
Measured: Up to 30 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Determined by inspection of the concentration-time profile
Measured: Up to 30 months
Plasma concentration half-life (T-HALF)
Determined by inspection of the concentration-time profile
Measured: Up to 30 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Assessment of preliminary efficacy of EOS100850
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start5 Feb 2019
- Primary completion28 May 2024
- Study completion28 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
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Iteos Clinical Trials, Study director, iTeos Belgium SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873883
- Sponsor's protocol ID
- IO-001
- Other IDs
- 2018-003173-10, Keynote A45, 2018
- Acronym
- IO-001
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
- Phase I/Ib First-in-Human Study of EOS100850 (Inupadenant) As a Single Agent and in Combination with Pembrolizumab And/or Chemotherapy in Participants with Advanced Cancers
- ClinicalTrials.gov ID
- NCT03873883
- Acronym / sponsor ID
- IO-001 / IO-001
- Conditions
- Solid Tumor, Adult
- Keywords
- solid, tumor, advanced cancers, pharmacokinetics, safety, inupadenant, pembrolizumab, chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA, Merck Sharp & Dohme LLC
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 14 Mar 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.
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1A Dose escalation EOS100850 | Experimental | Drug: EOS100850Dose Escalation- EOS100850 Monotherapy: to confirm RP2D |
| 1B Dose escalation EOS100850 and Pembrolizumab | Experimental | Drug: EOS100850, Drug: PembrolizumabEOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination |
| 2A Dose Expansion- EOS100850 | Experimental | Drug: EOS100850Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy |
| 2B Dose Expansion - EOS100850 and Pembrolizumab | Experimental | Drug: EOS100850, Drug: PembrolizumabDose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients |
| 2D Dose expansion - EOS100850 and Chemotherapy in TNBC | Experimental | Drug: EOS100850, Drug: ChemotherapyDose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC |
| 3 EOS100850 in BMK-H participants | Experimental | Drug: EOS100850Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer |
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 |
|---|---|---|
| EOS100850Also: InupadenantOral administration | Drug | 1A Dose escalation EOS100850, 1B Dose escalation EOS100850 and Pembrolizumab, 2A Dose Expansion- EOS100850, 2B Dose Expansion - EOS100850 and Pembrolizumab, 2D Dose expansion - EOS100850 and Chemotherapy in TNBC, 3 EOS100850 in BMK-H participants |
| PembrolizumabAlso: Keytruda, MK-3475IV Infusion | Drug | 1B Dose escalation EOS100850 and Pembrolizumab, 2B Dose Expansion - EOS100850 and Pembrolizumab |
| ChemotherapyAlso: carboplatin and paclitaxelStandard of Care IV Infusion | Drug | 2D Dose expansion - EOS100850 and Chemotherapy in TNBC |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
Time frame: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)
To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850
Incidence and severity of AEs in patients receiving EOS100850
Time frame: Up to 30 months
To assess safety and tolerability as measured by incidence and severity of AEs
6 secondary outcomes
Plasma concentration of EOS100850 vs. time profiles
Time frame: Up to 30 months
Maximum observed serum concentration (Cmax)
Time frame: Up to 30 months
Time of maximum observed concentration (Tmax)
Time frame: Up to 30 months
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Time frame: Up to 30 months
Plasma concentration half-life (T-HALF)
Time frame: Up to 30 months
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time frame: Up to 30 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.
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOS100850, Pembrolizumab and Chemotherapy in people with Solid Tumor, Adult, run by iTeos Therapeutics at 19 sites in 6 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 19 sites in Belgium, France, Spain, United States, South Korea and 1 more country. 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 EOS100850 (time frame: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 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.