EOS-448 for Cancer

(TIG-006 Trial)

Not currently recruiting at 58 trial locations

Overseen By iTeos Belgium SA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: iTeos Belgium SA

Must be taking: Anti-PD(L)1 therapy

Must not be taking: Immunotherapy, Chemotherapy

Disqualifiers: CNS cancer, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called EOS-448, alone or with other drugs, to determine its safety and effectiveness against advanced solid tumors. Different groups in the trial will receive combinations of EOS-448 with other therapies, such as dostarlimab (an immunotherapy drug), pembrolizumab (an immunotherapy drug), or chemotherapies. The trial seeks individuals with advanced cancers who have exhausted standard treatment options, including specific types like non-small cell lung cancer or head and neck cancer. Participants should have a diagnosed advanced cancer that hasn't responded to other treatments and maintain good overall health. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial requires that you have not received any anti-cancer therapy within 4 weeks before the first dose, so you may need to stop certain cancer treatments. However, the protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EOS-448, also known as belrestotug, is undergoing testing for safety in individuals with advanced solid tumors. When combined with treatments like dostarlimab and inupadenant, early results have been promising. Dostarlimab, used alongside chemotherapy, has improved patient outcomes and demonstrated safety, suggesting it might also be safe with EOS-448 and inupadenant.

Another combination involves pembrolizumab, frequently used with EOS-448. Many cancer studies have shown it to be safe, typically not causing severe side effects.

Overall, while EOS-448 remains under investigation, these combinations show potential for safety based on past studies. However, as these are early-phase trials, more information is needed to fully understand the safety of EOS-448 in these combinations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about EOS-448 for cancer treatment because it offers a unique approach compared to current options. Unlike traditional therapies that often target cancer cells directly, EOS-448 is an antibody that targets the TIGIT protein on immune cells, potentially enhancing the body's own immune response against cancer. This mechanism is particularly promising as it could work synergistically with other immunotherapies like dostarlimab and pembrolizumab, which are also part of the trial combinations. These combinations aim to boost the immune system's ability to recognize and attack cancer cells more effectively, offering hope for improved outcomes in various cancer types.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

In this trial, participants will receive various treatment combinations to assess their effectiveness against advanced solid tumors. EOS-448, one of the investigational treatments, has shown promise in previous studies by reducing certain cells in tumors, suggesting a treatment effect. Some participants will receive EOS-448 combined with dostarlimab, a pairing that has shown encouraging results in fighting tumors. Dostarlimab alone has helped some cancer patients live longer. Other participants will receive EOS-448 combined with inupadenant, which has shown early signs of effectiveness. Additionally, EOS-448 will be tested with pembrolizumab, known for enhancing the immune system's ability to fight tumors. These combinations aim to improve treatment outcomes by boosting the body's immune response to combat cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Iteos Clinical Trials

Principal Investigator

iTeos Belgium SA

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including melanoma, lung cancer, and head & neck cancers. Participants must have progressed on anti-PD-(L)1 therapy (for melanoma), or be eligible for first-line metastatic treatment combining anti-PD(L)1 therapy with chemotherapy. They should not have received recent anticancer therapies or live vaccines, nor should they have uncontrolled diseases or certain genetic aberrations indicating other treatments.

Inclusion Criteria

My head and neck cancer cannot be cured with surgery or radiation.

My cancer is advanced or has spread, and there are no standard treatments left.

Part 2 (H&N cancer): PD-L1 status positive

Exclusion Criteria

My brain metastases have been treated and stable for over a month.

I have not received a live vaccine in the last 30 days.

I have been diagnosed with a primary brain cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EOS-448 in combination with various therapies, including pembrolizumab, inupadenant, dostarlimab, and standard of care chemotherapies, depending on the trial arm

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dostarlimab
• EOS-448
• inupadenant
• Pembrolizumab
• SOC chemotherapies

Trial Overview The study tests EOS-448 combined with standard care and/or investigational drugs in patients with advanced tumors. It's an open-label phase I/II trial to assess safety, dosage, how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and its ability to fight tumors.

How Is the Trial Designed?

Group I: Part 2D - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants with 1L mHNSCC 1 \< CPS \< 20 will receive EOS-448 and dostarlimab at every cycle

Group II: Part 2C - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle

Group III: Part 1G - EOS-448 + dostarlimab + chemotherapies Experimental Treatment 3 Interventions

Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle

Group IV: Part 1F - EOS-448 + dostarlimab + inupadenant HC Experimental Treatment 3 Interventions

Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis

Group V: Part 1E - inupadenant HCl + dostarlimab Experimental Treatment 2 Interventions

Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis

Group VI: Part 1D - EOS-448 + dostarlimab Experimental Treatment 2 Interventions

Participants will receive EOS-448 and dostarlimab at every cycle

Group VII: Part 1C - EOS-448 + inupadenant Experimental Treatment 2 Interventions

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Group VIII: Part 1B - EOS-448 + inupadenant Experimental Treatment 2 Interventions

Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis

Group IX: Part 1A - EOS-448 + pembrolizumab Experimental Treatment 2 Interventions

Participants will receive EOS-448 and pembrolizumab at every cycle

Who Is Running the Clinical Trial?

iTeos Belgium SA

Lead Sponsor

Trials

9

Recruited

950+

iTeos Therapeutics

Industry Sponsor

Trials

11

Recruited

2,500+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05060432

NCT05060432 | Study of EOS-448 With Standard of Care ... This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor ...

2. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/LB189/701097/Abstract-LB189-Pharmacodynamic-assessment-of-a

Pharmacodynamic assessment of a-TIGIT mAb EOS-448 ... In a first-in-human trial, EOS-448 demonstrated a good tolerability profile with early signs of efficacy4. Pharmacodynamic assessment made by ...

3. firstwordpharma.com firstwordpharma.com/story/5544855

iTeos Presents New Data for Anti-TIGIT Antibody, EOS-448/ ... Treatment with EOS-448 results in a decrease of TIGIT-positive cells in tumor biopsies, the first evidence of a treatment effect in the tumors of patients ...

4. nasdaq.com nasdaq.com/press-release/iteos-presents-new-data-for-anti-tigit-antibody-eos-448-gsk4428859a-at-the-aacr

iTeos Presents New Data for Anti-TIGIT Antibody, EOS-448 ... Treatment with EOS-448 results in a decrease of TIGIT-positive cells in tumor biopsies, the first evidence of a treatment effect in the tumors of patients ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT04335253

First-In-Human Study of EOS884448 in Participants with ... Updated single-agent data, including results from tumor biopsy analyses, and initial pembrolizumab combination data are expected to be reported later in 2021; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39346117/

Safety of dostarlimab in combination with chemotherapy ... Dostarlimab plus carboplatin-paclitaxel (CP) significantly improved progression-free survival and overall survival compared with CP alone.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-eos884448-dostarlimab-and-inupadenant-for-patients-with-advanced-solid-tumors/

Study of EOS884448, Dostarlimab, and Inupadenant for ... This clinical trial tests the efficacy and safety of EOS884448, Dostarlimab, and Inupadenant in treating patients with advanced solid tumors ...

8. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05060432

EOS-448 With Standard of Care and/or Investigational ... This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor ...