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EOS100850

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |iTeos Therapeutics, Inc.|Last Updated: Sep 19, 2024

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

EOS100850 · 1 trial · 1 indication

Phase 1 1
NCT03873883First-in-Human Study of EOS100850 (Inupadenant) in Patients with CancerSolid Tumor, Adult
COMPLETED119 Analytics
PHASE1COMPLETED
First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
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
Up to 30 months

To assess safety and tolerability as measured by incidence and severity of AEs

Secondary Endpoints

Plasma concentration of EOS100850 vs. time profiles
Up to 30 months
Maximum observed serum concentration (Cmax)
Up to 30 months
Time of maximum observed concentration (Tmax)
Up to 30 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1A Dose escalation EOS100850EXPERIMENTALDose Escalation- EOS100850 Monotherapy: to confirm RP2D
1B Dose escalation EOS100850 and PembrolizumabEXPERIMENTALEOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
2A Dose Expansion- EOS100850EXPERIMENTALDose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy
2B Dose Expansion - EOS100850 and PembrolizumabEXPERIMENTALDose 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 TNBCEXPERIMENTALDose 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 participantsEXPERIMENTALDose 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

Interventions

NameTypeDescription
EOS100850DRUGOral administration
PembrolizumabDRUGIV Infusion
ChemotherapyDRUGStandard of Care IV Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

For more information regarding participation in the Trial, please refer to your physician Inclusion Criteria: * 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 f...

Countries:United StatesBelgiumFranceSouth KoreaSpainUnited Kingdom
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Frequently asked questions about EOS100850

What is EOS100850 used for in Solid Tumor, Adult?

EOS100850 is an investigational small molecule being studied for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, with a completed first-in-human trial that enrolled 119 patients. The drug is not yet approved and remains under investigation.

What does EOS100850 target?

EOS100850 is a small molecule developed by iTeos Therapeutics. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its potential in oncology, specifically for solid tumors in adult patients.

Who makes EOS100850?

EOS100850 is developed by iTeos Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ITOS. The company is conducting clinical research on this investigational small molecule for the treatment of solid tumors.

What phase is EOS100850 in?

EOS100850 is in Phase 1 clinical development. A first-in-human study (NCT03873883) has been completed, involving 119 patients with solid tumors. The drug is investigational and has not received regulatory approval.

What clinical trials is EOS100850 in?

EOS100850 has one completed clinical trial, NCT03873883, titled 'First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer.' This Phase 1 study enrolled 119 adults with solid tumors across the United States, Belgium, France, South Korea, Spain, and the United Kingdom.

Is EOS100850 the same as Inupadenant?

Yes, EOS100850 is also known as Inupadenant. The completed clinical trial NCT03873883 refers to the drug as EOS100850 (Inupadenant), confirming that these names refer to the same investigational small molecule being developed by iTeos Therapeutics.