Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Known history of allergy to any component of study intervention.
• •2. History of severe allergic/anaphylactic reaction.
• •3. Infection with HIV-1 or HIV-2 or a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
• •4. Current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive), hepatitis B (hepatitis B virus \[HBV\] surface antigen positive), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid). Patients with HCV with undetectable virus after treatment are eligible (note: patients must have completed curative antiviral therapy at least 4 weeks before screening).
• •5. Pregnancy and/or lactation
• •6. Has received a live or live-attenuated vaccine within 28 days before the first dose of study intervention. Note: Administration of killed vaccines and COVID-19 vaccines that are not live or live-attenuated are allowed if \>14 days before the first dose.
• •7. History of any active infection requiring systemic antibiotics, antivirals or antifungals within 14 days before the first dose of study intervention, including COVID-19 as determined by the currently recommended testing strategy for acute infection.
• •8. Any acute noninfectious illness not resolved by14 days before day 1.
• •9. History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, Type I diabetes, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received treatment for their autoimmune disorder in the past 3 years.
• •10. Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks before study entry and have no evidence of new or enlarging brain metastases.
• •11. Unresolved toxicities from prior anticancer therapy, defined as not resolved to baseline or to grade 1 by the CTCAE V 5.0 criteria (NCI 2017) except for alopecia, peripheral neuropathy, and hypothyroidism secondary to prior checkpoint inhibitor therapy if currently being treated and clinically euthyroid.
• •12. Receipt of any investigational agent or treatment within a period of 5 half-lives (or 28 days whichever is shorter) before the first dose of study intervention.
• •13. Any prior immunotherapy or treatment with checkpoint inhibitors, unless approved by the Sponsor, within a period of 5 half-lives (or 3 months, whichever is shorter) since the last dose of the therapy.
• •14. Use of systemic steroids \>10 mg/day prednisone (or equivalent) within 14 days of enrollment, except for local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (eg, in patients with exacerbation of reactive airway disease) must have been completed at least 10 days before enrollment. Steroid use to prevent IV contrast allergic reaction or anaphylaxis in patients who have known contrast allergies is allowed at any time before enrollment.
• •15. Active known second malignancy except any of the following:
• •* Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or Stage 0 carcinoma in situ
• •* Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥2 years
• •* Low-risk prostate cancer with Gleason score \<7 and prostate-specific antigen \<10 ng/mL
• •* Any other cancer from which the patient has been disease-free for ≥2 years
• •16. Use of biotin (ie Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg (FDA 2019) (Note: patients who switch from a high dose to a dose of 30 μg/day or less are eligible).
• •17. Any of the following events within 6 months before baseline Day 1:
• •* Myocardial infarction
• •* Unstable angina
• •* Unstable symptomatic ischemic heart disease
• •* New York Heart Association class III or IV heart failure
• •* Thromboembolic events (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)
• •18. Electrocardiogram QT interval corrected for heart rate (QTc) \> 470 msec, measured by Fridericia's formula \[QTcF=QT/(RR0.33)\]. If the QTc is prolonged in a patient with a pacemaker or bundle branch block, the patient may be enrolled in the study if confirmed by the medical monitor.