Advanced Solid TumorsPhase 1NCT06547957
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
A Phase 1 study testing EOS301984 and Anti-PD-1 monoclonal antibody in people with Advanced Solid Tumors, run by iTeos Therapeutics at 6 sites in Belgium.
Trial summary
APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies 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
- Advanced Solid Tumors
- What is being tested?
- EOS301984 and Anti-PD-1 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 6 sitesBelgium
- Study dates
- 7 Jul 2023to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Provide a signed written informed consent before any study-specific evaluation.
- Be at least 18 years old on the day of signing informed consent.
- Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment.
- Have at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have adequate organ and marrow function.
- Agree to use adequate highly effective method of contraception during the study is mandatory, if Women of Childbearing Potential (WOCBP) or male.
Who cannot join
- Have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment.
- Have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment.
- Have received prior radiotherapy within 2 weeks before the first dose of study treatment.
- Have allergy to study treatment(s) or any of its components.
- Have a history or current evidence of uncontrolled or significant cardiovascular disease. Unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
- Pregnant or breastfeeding women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Institut Jules Bordet
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Grand Hopital de Charleroi
Charleroi, 6060
Universitair Ziekenhuis Gent
Ghent, 9000
CHU de Liège
Liège, 4000
GZA Ziekenhuizen campus Sint-Augustinus
Wilrijk, 2610
About this study
Official title: A First-in-Human Open-label, Phase I Dose Escalation and Expansion Cohort Study of EOS301984 as Monotherapy and in Combination With Other,Anticancer Treatments in Participants With Advanced Solid Tumors
APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- EOS301984, Anti-PD-1 monoclonal antibody
- Keywords
- Advanced solid tumors, neoplasm, cancer, phase I, immunotherapy, anticancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS301984Drug
Also called EOS-984
Multiple doses of EOS301984
Anti-PD-1 monoclonal antibodyDrug
Multiple doses of EOS301984 in combination with Anti-PD-1
| Study group | Role | What they receive |
|---|---|---|
| Part 1A dose escalation | Experimental | EOS301984 dose escalation as monotherapy Receives: Drug: EOS301984 |
| Part 1B dose escalation | Experimental | EOS301984 in combination with other cancer therapies Receives: Drug: EOS301984; Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
Measured: From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984
Measured: From first study treatment administration to last participant last follow-up (Up to 4 years)
Secondary outcomes (4)
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level
Measured: From first dose up to 21 days repeated cycles
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level
Measured: From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.
Measured: From first study treatment administration to last participant last follow-up (Up to 4 years)
Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From first study treatment administration to last participant last follow-up (Up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start7 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iteos Clinical Trials, Study director, iTeos Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547957
- Sponsor's protocol ID
- APT-008
- Other IDs
- 2023-503844-14-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 28 Mar 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Open-label, Phase I Dose Escalation and Expansion Cohort Study of EOS301984 as Monotherapy and in Combination With Other,Anticancer Treatments in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06547957
- Acronym / sponsor ID
- APT-008
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumors, neoplasm, cancer, phase I, immunotherapy, anticancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1A dose escalation | Experimental | Drug: EOS301984EOS301984 dose escalation as monotherapy |
| Part 1B dose escalation | Experimental | Drug: EOS301984, Drug: Anti-PD-1 monoclonal antibodyEOS301984 in combination with other cancer therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide a signed written informed consent before any study-specific evaluation.
- Be at least 18 years old on the day of signing informed consent.
- Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment.
- Have at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (6 listed)
- Have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment.
- Have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment.
- Have received prior radiotherapy within 2 weeks before the first dose of study treatment.
- Have allergy to study treatment(s) or any of its components.
- Have a history or current evidence of uncontrolled or significant cardiovascular disease. Unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
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 |
|---|---|---|
| EOS301984Also: EOS-984Multiple doses of EOS301984 | Drug | Part 1A dose escalation, Part 1B dose escalation |
| Anti-PD-1 monoclonal antibodyMultiple doses of EOS301984 in combination with Anti-PD-1 | Drug | Part 1B dose escalation |
Primary outcome
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Incidence and severity of AEs in patients receiving EEOS301984
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
4 secondary outcomes
Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level
Time frame: From first dose up to 21 days repeated cycles
Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level
Time frame: From first dose up to 21 days repeated cycles
Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 Therapeutics Inc.
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 EOS301984 and Anti-PD-1 monoclonal antibody in people with Advanced Solid Tumors, run by iTeos Therapeutics at 6 sites in Belgium.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors (time frame: From first study treatment administration to last participant last follow-up (Up to 4 years)). 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 13 Aug 2025.