First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors

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 tumorswho have been previously treated with SoC and are no longer eligible for othertherapies

6. Patients who have been treated with an ICI treatment as monotherapy or incombination 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 thelast study treatment administration for WOCBP, and for male patients who aresexually active with WOCBP. Highly effective contraception methods are defined as:

• Hormonal methods of contraception including combined oral contraceptive pills,vaginal ring, injectable, implants, intrauterine devices such as Mirena andnonhormonal intrauterine devices such as ParaGard for WOCBP patients or malepatients' WOCBP partners

• Tubal ligation

• Vasectomy In addition to highly effective contraception, participating male patients:

• Must use a condom during the study period and for 3 months after the last studytreatment administration when engaging in any activity that allows for exposureto ejaculate

• Must refrain from donating sperm

12. Must agree to abstain from donating blood while taking study drug and for 3 monthsfollowing discontinuation of study treatment

13. Able to understand the character and individual consequences of clinical trial

Exclusion Criteria:

1. Patients with central nervous system metastases and/or leptomeningeal carcinomatosiswith some exceptions

2. Patients with active or a documented history of autoimmune disease, immunedeficiency or syndrome that required systemic corticoids (except the allowed dose)or immunosuppressive medications

3. Patients who received a previous ICI like anti-PD(L)-1 or an agent directed toanother stimulatory or co-inhibitory T-cell receptor and was discontinued from thattreatment due to toxicity

4. Patients under chronic treatment with systemic corticosteroids or otherimmunosuppressive drugs for a period of at least 4 weeks and whose treatment was notstopped 2 weeks prior to the first study treatment, with exceptions. Steroids withno or minimal systemic effect (topical, inhalation) are allowed

5. Patients with history of or current interstitial lung disease or fibrosis, andpatients with pneumonitis

6. Other active malignancy requiring active intervention

7. Patients with previous malignancies other than the target malignancy to beinvestigated in this trial, unless a complete remission was achieved and noadditional therapy is required during the study period

8. Patient with any organ transplantation, including allogeneic stem celltransplantation

9. Known severe hypersensitivity reactions to monoclonal antibodies, any history ofanaphylaxis, or uncontrolled asthma

10. Any known allergy or severe reaction to any component of anti-CTLA-4 or anti-PD(L)-1drug product

11. Significant chronic or acute infections requiring systemic therapy includingSARS-CoV-2 (COVID-19) PCR positive testing

12. Clinically significant active cardiovascular disease

13. Any other medical conditions or psychological disorders that would increase thesafety risk to the patient or interfere with participation of the patient or theevaluation of the clinical study in the opinion of the investigator

14. Pregnant, breastfeeding, or expecting to conceive or father children within theprojected duration of the trial