A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination

Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for enrollment intothe study:

1. Histologically or cytologically-documented solid tumors that are inoperable locallyadvanced, metastatic, or recurrent:

• Part 1 Dose Escalation: Patients with any solid tumor who have progressed on orare intolerant to standard therapy, for which no standard therapy is available,or who decline standard therapy.
• Part 2: Dose Expansion: Patients must have received at least one prior line ofstandard therapy in recurrent/metastatic setting and for whom standardlife-prolonging therapies are either not available or are not qualified toreceive such therapies. Additional general and tumor specific inclusion andexclusion criteria will apply.

2. Patients who have at least one measurable lesion, as defined by RECIST v1.1.
3. Adult male or female patients ≥18 years of age on day of signing the informed consentform (ICF) or follow local regulatory requirement if the legal age for consenting forstudy participation is more than 18 years.
4. Patients who are able and willing to provide written informed consent and are willingand able to comply with all study procedures.
5. Patients with life expectancy of ≥3 months.
6. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0or 1.
7. Patients who demonstrate adequate organ function as defined.
8. Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the NCI CTCAE v5.0 (exception of alopecia and other AEs that areacceptable in the opinion of the Investigator and after discussion with the MedicalMonitor)
9. Willingness of male and female patients of reproductive potential to observeconventional and effective birth control methods with failure rates of <1% for theduration of treatment and for 3 months (6 months for female patients administeringgemcitabine) following the last dose of study treatment. This must include barriermethods such as condom or diaphragm with spermicidal gel. Women of childbearingpotential (WOCBP) are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For malepatients with a nonpregnant female partner of childbearing potential and a WOCBP, 1 ofthe following highly effective birth control methods, with a failure rate of less than 1% per year when used consistently and correctly, is recommended:
10. Combined estrogen and progestin containing hormonal contraception associated withinhibition of ovulation given orally, intravaginally, or transdermally
11. Progestin-only hormonal contraception associated with inhibition of ovulationgiven orally, by injection, or by implant
12. Intrauterine device
13. Intrauterine hormone-releasing system
14. Bilateral tubal occlusion/ligation
15. Vasectomized partner
16. Sexual abstinence Note: Sexual abstinence is considered a highly effective methodonly if defined as refraining from heterosexual intercourse during the entireperiod of risk associated with the study drug. The reliability of sexualabstinence needs to be evaluated in relation to the duration of the study and thepreferred and usual lifestyle of the patient. Birth control methods unacceptable for this study include the following:
17. Periodic abstinence (calendar, symptom-thermal, or post-ovulation methods)
18. Withdrawal (coitus interruptus)
19. Spermicide only
20. Lactational amenorrhea method
21. Sperm donation is prohibited during the duration of participation on thisprotocol and for 90 days after the last dose of study drug
22. WOCBP must have a documented negative serum or urine pregnancy at screening within 3calendar days before the first dose of study drug. Females who are not of childbearingpotential must have documented:
23. Postmenopausal status, defined as cessation of regular menses for at least 12months and documented serum follicle stimulating hormone (FSH) levels that arewithin laboratory reference range for postmenopausal women, or
24. Have undergone a documented hysterectomy or bilateral oophorectomy, or
25. Have medically confirmed ovarian failure.

Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible toparticipate:

1. Prior history of or active malignant disease other than that being treated in thisstudy. Exceptions: (i) Malignancies that were treated curatively and have not recurred withinthe past 2 years, or (ii) Completely resected basal cell carcinoma and squamous cellcarcinoma of the skin, or (iii) Completely resected carcinoma in situ of any type.
2. Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy and/ or surgery (including radiosurgery) and stable for at least 4 weeksbefore first dose of study drug. Note: patients with an incidental finding of anisolated lesion <1 cm in diameter may be eligible if the lesion does not requiretreatment per investigator judgment. Eligible patients must be neurologicallyasymptomatic and without corticosteroids treatment for at least 2 weeks prior to startof first dose of study treatment.
3. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy, or anyimmunosuppressive therapy within 7 days prior to first dose of study drug. Topical (<class III), inhaled, nasal, and ophthalmic steroids are allowed.
4. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressivedrugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a formof systemic treatment.
5. History of Grade 3 or higher immune mediated AEs that were considered drug related toprior immunotherapy (e.g., checkpoint inhibitors, co-stimulatory agents).
6. Infection with HIV-1 or HIV-2. Active hepatitis B (hepatitis B virus [HBV] surfaceantigen positive), hepatitis C (hepatitis C virus [HCV] antibody positive, confirmedby HCV ribonucleic acid). Patients with prior history of HBV are eligible ifquantitative polymerase chain reaction (PCR) for HBV DNA is negative. Patients withHCV with undetectable virus after treatment, and those who have minimal viral load (<20 IU/ml) at screening and who are being treated with HCV therapy during the fullstudy period are eligible.
7. Has an active infection requiring systemic therapy
8. Has significant cardiovascular disease, such as:
9. QT interval corrected for heart rate using Fridericia's formula > 480 msec atscreening
10. History of myocardial infarction, acute coronary syndrome or coronaryangioplasty/stenting/bypass grafting within the last 6 months
11. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV orhistory of CHF NYHA class III or IV
12. Patients exhibiting significant respiratory symptoms, those with suspected or knownserious or severe respiratory conditions and those requiring supplemental oxygen atscreening.
13. Receipt of any type of systemic anticancer therapy (including investigational therapy)within 3 weeks before the first dose of study drug or 5 times elimination half-life ofdrug, if known, has passed whatever is shorter.
14. Is currently participating in or has participated in an interventional clinical trialwith last dose of the investigational compound or device within 3 weeks of the firstdose of treatment in this current trial. Patients who are in survival follow up can beenrolled if the last dose was 3 weeks earlier.
15. Radiation within 2 weeks before first dose of study treatment. Patients withclinically relevant ongoing complications from prior RT are not eligible.
16. Major surgery within 2 weeks prior to study drug administration; patients must haverecovered adequately from toxicity and/ or complications per investigator discretion.
17. Receipt of any live vaccines within 4 weeks prior to first dose of study drug.
18. Receipt of non-live COVID-19 vaccine within 7 days prior to DLT evaluation becausevaccine related toxicities could interfere safety assessment.
19. Any prior treatment with IL-2 based drug.
20. Has a known hypersensitivity to the components of the study therapy or its analogs.
21. Has a history or current evidence of any condition therapy, lab abnormality or othercircumstance that might expose the patient to risk by participating in the trial,confound the results of the trial, or interfere with the patient's participation forthe full duration of the trial.
22. Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial
23. For women only: pregnant or breastfeeding