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EOS100850 + Immunotherapy/Chemotherapy for Cancer

Phase 1
Waitlist Available
Research Sponsored by iTeos Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 4 weeks since any previous treatment for cancer
Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 month
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see how well it works and if it has any side effects.

Who is the study for?
Adults over 18 with advanced solid tumors, no standard treatment options left, and a performance status showing they're still fairly active. They must have finished any previous cancer treatments at least 4 weeks ago and agree to tumor biopsies before and during the trial. Their organs and bone marrow should work well.Check my eligibility
What is being tested?
This study is testing EOS100850 alone or combined with Pembrolizumab (an immunotherapy drug) or Chemotherapy in people with advanced cancers. It's an early-phase trial to find out the safest dose, how the body processes it, its effects on tumors, and side effects.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by EOS100850 or Pembrolizumab such as fatigue, skin issues, inflammation of organs; chemotherapy may cause nausea, hair loss, blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been over 4 weeks since my last cancer treatment.
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I am 18 or older and can care for myself with minimal assistance.
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My advanced cancer has no standard treatments left.
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My organs and bone marrow are working well.
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I agree to have tumor biopsies before and during treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of AEs in patients receiving EOS100850
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
Secondary outcome measures
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Maximum observed serum concentration (Cmax)
Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: 3 EOS100850 in BMK-H participantsExperimental Treatment1 Intervention
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
Group II: 2D Dose expansion - EOS100850 and Chemotherapy in TNBCExperimental Treatment2 Interventions
Dose expansion - EOS100850 and Chemotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC
Group III: 2B Dose Expansion - EOS100850 and PembrolizumabExperimental Treatment2 Interventions
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
Group IV: 2A Dose Expansion- EOS100850Experimental Treatment1 Intervention
Dose Expansion- Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy
Group V: 1B Dose escalation EOS100850 and PembrolizumabExperimental Treatment2 Interventions
EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
Group VI: 1A Dose escalation EOS100850Experimental Treatment1 Intervention
Dose Escalation- EOS100850 Monotherapy: to confirm RP2D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

iTeos TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,424 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,581 Total Patients Enrolled

Media Library

Chemotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03873883 — Phase 1
Solid Tumors Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT03873883 — Phase 1
Chemotherapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03873883 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic purpose does EOS100850 typically serve?

"The drug EOS100850 is primarily used to combat malignant neoplasms and can also be employed in treating unresectable melanomas, microsatellite instability high diseases, and cancer relapse after chemotherapy."

Answered by AI

How many volunteers are involved in this investigation?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants after being first uploaded on January 28th 2019 and most recently updated on June 27th 2022. The trial requires 201 people from a single site for enrollment."

Answered by AI

Has the FDA sanctioned EOS100850 for use?

"Our organisation assigned EOS100850 a score of 1 due to the lack of reliable information regarding its safety and efficacy - as it is currently in Phase 1."

Answered by AI

What is the purpose of this experiment?

"This clinical experiment will span up to 15 months, with the primary goal being assessing the incidence of Dose-Limiting Toxicities in patients affected by advanced solid tumors which are administered EOS100850. Secondary objectives include determining Plasma concentration half-life (T-HALF), Maximum observed serum concentrations (Cmax) and Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST)."

Answered by AI

Could you elaborate on the existing research surrounding EOS100850?

"Presently, there are 961 clinical trials that include EOS100850. Of these studies, 122 have advanced to the third phase of evaluation. The majority of these investigations based in Houston, Texas; however other cities around the world are hosting tests for this drug with a total of 35731 sites participating."

Answered by AI

Are there any vacancies available to partake in this clinical trial?

"Clinicaltrials.gov attests that, as of June 27th 2022, this clinical investigation is actively seeking participants--it was initially announced on January 28th 2019."

Answered by AI
~19 spots leftby Mar 2025