What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and immunotherapy, have a range of side effects. Chemotherapy agents like etoposide and platinum-based drugs often cause myelosuppression, leading to neutropenia, anemia, and thrombocytopenia. Other side effects include nausea, vomiting, fatigue, and alopecia. Immunotherapy agents, such as pembrolizumab, can cause immune-related adverse events, including colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. These treatments require careful monitoring and management to mitigate their impact on patients' quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly those involving immune checkpoint inhibitors. Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are notable examples, both targeting the PD-1 pathway to enhance the immune system's ability to fight cancer. These drugs have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, combination therapies involving these inhibitors and other agents, such as chemotherapy or targeted therapies, have also received FDA approval, expanding the treatment options for patients with advanced solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in non-small cell lung cancer (NSCLC) as per the KEYNOTE-189 trial. 2) Atezolizumab in combination with chemotherapy, which has demonstrated benefits in various NSCLC trials such as IMpower150 and IMpower130. 3) Lutetium Lu 177 vipivotide tetraxetan, approved for PSMA-positive metastatic castration-resistant prostate cancer, showing improved progression-free and overall survival in the VISION trial. 4) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and other solid tumors.

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EOS100850 + Immunotherapy/Chemotherapy for Cancer (IO-001 Trial)

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

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called EOS100850, along with Pembrolizumab and Chemotherapy, in patients with advanced cancers. The goal is to see if these treatments can work alone or together to better fight cancer by stopping its growth, helping the immune system attack it, and killing cancer cells.

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.

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.

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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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of AEs in patients receiving EOS100850

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 Combination: 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 - EOS100850 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

Chemotherapy

2003

Completed Phase 4

~3050

Pembrolizumab

2017

Completed Phase 3

~2810

EOS100850

2019

Completed Phase 1

~120

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy, such as immune checkpoint inhibitors, enhances the body's immune response against cancer cells by targeting proteins like PD-1/PD-L1 or CTLA-4, which tumors use to evade immune detection. Targeted therapies focus on specific molecular targets associated with cancer growth and survival, such as HER2 in breast cancer or EGFR in lung cancer. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations regarding efficacy and side effects, and exploring potential participation in clinical trials for novel therapies like EOS100850.

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