Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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 combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.: EOS-448 will be combined with pembrolizumab, a marketed anti-PD-1 antibody in one treatment arm and a second treatment arm will evaluate EOS-448 combined with inupadenant, an investigational adenosine A2A receptor antagonist.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: iTeos Belgium SA
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Provide a signed written informed consent for the trial

• Have measurable disease, per RECIST v1.1

• Have a predicted life expectancy of ≥ 16 weeks

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.

• Have adequate organ functions

• Part 1 : Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available

• Part 2 (lung cancer, H&N) Are eligible to receive pembrolizumab monotherapy in first line (1L) metastatic setting, as standard of care and according to local treatment guidelines.

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

• Part 2 (melanoma) : progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb)

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 5 weeks before initiating treatment

• Part 1 : Have received prior radiotherapy within 2 weeks of start of study treatment

• Part 2 (lung cancer, H&N) :Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS1) or any other genomic aberration approved directed therapy is indicated as primary therapy.