Clinical trial · Interventional
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab | ALIAS |
| EOS-448 | Drug | — | UNRESOLVED |
| inupadenant | Drug | — | UNRESOLVED |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
| SOC chemotherapies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Part 1A - EOS-448 + pembrolizumab
- description
- Participants will receive EOS-448 and pembrolizumab at every cycle
- interventionNames
- Drug: EOS-448
- Drug: pembrolizumab
- type
- EXPERIMENTAL
- label
- Part 1B - EOS-448 + inupadenant
- description
- Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis
- interventionNames
- Drug: EOS-448
- Drug: inupadenant
- type
- EXPERIMENTAL
- label
- Part 1C - EOS-448 + inupadenant
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available