First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors
Trial Parameters
Brief Summary
This multicenter, open-label, first-in-human, Phase 1/2 study consists of a Part 1 (Phase 1) open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PD(L)-1 treatment, followed by a Part 2 (Phase 2) open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent and/or metastatic solid tumors as monotherapy and/or combination therapy with anti-PD(L)-1.
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent 2. Female or male patients, aged at least 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Life expectancy of at least 3 months as assessed by the investigator 5. Patients with confirmed locally advanced, unresectable, or metastatic solid tumors who have been previously treated with SoC and are no longer eligible for other therapies 6. Patients who have been treated with an ICI treatment as monotherapy or in combination as SoC 7. Have recovered from previous treatment 8. At least 1 measurable lesion according to RECIST Version 1.1 9. Adequate hematological, hepatic, and renal functions 10. Negative blood pregnancy test at screening for women of childbearing potential 11. Highly effective contraception during the study period and for 6 months after the last study treatment administration for WOCBP, and for male patients who are sexually active with WOCBP. Highly effective contraception methods are d