Trial record 1 of 1 for:
05060432
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors (TIG-006)
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| ClinicalTrials.gov Identifier: NCT05060432 |
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Recruitment Status :
Recruiting
First Posted : September 29, 2021
Last Update Posted : December 27, 2023
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Sponsor:
iTeos Belgium SA
Collaborators:
GlaxoSmithKline
iTeos Therapeutics
Information provided by (Responsible Party):
iTeos Therapeutics ( iTeos Belgium SA )
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Brief Summary:
This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer Lung Cancer Head and Neck Cancer Melanoma | Drug: EOS-448 Drug: pembrolizumab Drug: inupadenant Drug: Dostarlimab Drug: SOC chemotherapies | Phase 1 Phase 2 |
The combinations evaluated will be:
- EOS-448 combined with pembrolizumab, an anti-PD-1 antibody
- EOS-448 combined with inupadenant an investigational adenosine A2A receptor antagonist
- EOS-448 combined with dostarlimab an anti-PD-1 antibody
- inupadenant combined with dostarlimab
- EOS-448 combined with inupadenant and dostarlimab
- EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with NSCLC
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 254 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors |
| Actual Study Start Date : | September 6, 2021 |
| Estimated Primary Completion Date : | September 2024 |
| Estimated Study Completion Date : | January 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1A - EOS-448 + pembrolizumab
Participants will receive EOS-448 and pembrolizumab at every cycle
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: pembrolizumab Anti-PD-1 monoclonal antibody |
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Experimental: Part 1B - EOS-448 + inupadenant
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant A2A receptor antagonist
Other Name: EOS100850 |
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Experimental: Part 1C - EOS-448 + inupadenant
Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant A2A receptor antagonist
Other Name: EOS100850 |
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Experimental: Part 1D - EOS-448 + dostarlimab
Participants will receive EOS-448 and dostarlimab at every cycle
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab Anti-PD-1 monoclonal antibody |
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Experimental: Part 1E - inupadenant HCl + dostarlimab
Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis
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Drug: inupadenant
A2A receptor antagonist
Other Name: EOS100850 Drug: Dostarlimab Anti-PD-1 monoclonal antibody |
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Experimental: Part 1F - EOS-448 + dostarlimab + inupadenant HC
Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: inupadenant A2A receptor antagonist
Other Name: EOS100850 Drug: Dostarlimab Anti-PD-1 monoclonal antibody |
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Experimental: Part 1G - EOS-448 + dostarlimab + chemotherapies
Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab Anti-PD-1 monoclonal antibody Drug: SOC chemotherapies SOC chemotherapies in 1L mNSCLC |
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Experimental: Part 2C - EOS-448 + dostarlimab
Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab Anti-PD-1 monoclonal antibody |
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Experimental: Part 2D - EOS-448 + dostarlimab
Participants with 1L mHNSCC 1 < CPS < 20 will receive EOS-448 and dostarlimab at every cycle
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Drug: EOS-448
Anti-TIGIT monoclonal antibody
Other Names:
Drug: Dostarlimab Anti-PD-1 monoclonal antibody |
Primary Outcome Measures :
- Percentage of participants with DLT and Adverse Events [ Time Frame: From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose ]
- Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors [ Time Frame: Up to 48 weeks ]
- Percentage of participants with Objective Response as determined by Investigator [ Time Frame: Until disease progression - Approximately 48 months ]
Secondary Outcome Measures :
- Duration of Response (DOR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
- Disease Control Rate (DCR) [ Time Frame: Until disease progression or death - Approximately 48 months ]
- Progression-free-survival (PFS) [ Time Frame: Until disease progression or death - Approximately 48 months ]
- Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level [ Time Frame: Up to 48 weeks ]
- Percentage of participants with anti-drug antibodies to EOS884448 [ Time Frame: Up to 48 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide a signed written informed consent for the trial
- Have measurable disease, per RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
- Have adequate organ functions
- Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available
Part 1G (NSCLC):
- Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.
- Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting
Part 2 (H&N cancer)
- Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
- PD-L1 status positive
Exclusion Criteria:
- Have received any anti-cancer therapy within 4 weeks prior to the first dose
- Have received a live vaccine within 30 days prior to the first dose
- Have known primary CNS cancer.
- Have known CNS metastases unless previously treated and well controlled for at least 1 month
- Have concomitant second malignancies unless a complete remission was achieved at least 2 years before study entry
- Have a history of Grade ≥ 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥ 2
- Have toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
- Have uncontrolled or significant cardiovascular disease
- Part 1: major surgery within 3 weeks before initiating treatment
- Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment
- Part 2 (H&N cancer):
- Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed > 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060432
Contacts
| Contact: iTeos Belgium SA | +32 71 91 99 33 | clinical_info@iteostherapeutics.com |
Locations
Show 41 study locations
Sponsors and Collaborators
iTeos Belgium SA
GlaxoSmithKline
iTeos Therapeutics
Investigators
| Study Director: | Iteos Clinical Trials | iTeos Belgium SA |
| Responsible Party: | iTeos Belgium SA |
| ClinicalTrials.gov Identifier: | NCT05060432 |
| Other Study ID Numbers: |
TIG-006 |
| First Posted: | September 29, 2021 Key Record Dates |
| Last Update Posted: | December 27, 2023 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by iTeos Therapeutics ( iTeos Belgium SA ):
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EOS884448 GSK4428859A TIGIT Anti-TIGIT EOS-448 pembrolizumab dostarlimab |
inupadenant A2A Receptor antagonist EOS-850 EOS100850 Anti-PD-1 monoclonal antibody belrestotug |
Additional relevant MeSH terms:
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Head and Neck Neoplasms Neoplasms Neoplasms by Site Pembrolizumab Dostarlimab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |