Overview

This is a phase I/II non-randomized, open-label, single-arm, multicenter study to evaluate the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors.

Eligibility

Inclusion Criteria:

        Participants are eligible to be included in the study only if all of the following criteria
        apply:
          1. Age ≥18 years and <76 years at the time of signing informed consent, male or female;
          2. Histologically or cytologically confirmed locally advanced or metastatic solid tumors
             that have progressed on or intolerant to standard therapy or whom no standard therapy
             exists;
          3. ECOG score: 0-1;
          4. Life expectancy of 3 months or more;
          5. Phase II: have measurable disease based on RECIST 1.1 ;
          6. Phase II: agree to provide archival tumor tissue or newly obtained biopsy of a tumor
             lesion ;
          7. Have adequate organ function ;
          8. A male or female participant must agree to use contraception during the treatment
             period and for at least 6 months after the last dose of study treatment ;
          9. Voluntary agreement to provide written informed consent and the willingness and
             ability to comply with all aspects of the protocol.
        Exclusion Criteria:
        Subjects meeting any of the following criteria must be excluded from this study:
          1. Known hypersensitivity to CSF-1R inhibitors or Sintilimab;
          2. Receipt of (or planned receipt of) anti-tumor therapies within 4 weeks prior to first
             dose through the end of the study treatment period;
          3. Incomplete recovery from prior therapy toxicities (i.e. grade 2 or higher toxicities
             at screening, except for alopecia, pigmentation changes, or immune-mediated
             hypothyroidism that is stable with hormone replacement);
          4. History of malignancies other than the cancer being treated in this study (Exceptions
             include: malignancies that have been cured with no recurrence within 3 years prior to
             enrollment; completely resected basal cell or squamous cell skin cancer; any
             completely resected carcinoma in situ);
          5. Major surgery (grade III or IV surgery) within 4 weeks prior to first dose without
             complete recovery;
          6. History of prior surgeries or severe gastrointestinal diseases such as dysphagia,
             active gastric ulcers, ulcerative colitis, Crohn's disease, intestinal obstruction
             etc., that may affect absorption, distribution, metabolism of study treatment per
             investigator's judgement;
          7. Any significant clinical or laboratory abnormalities that are considered clinically
             significant per investigator's judgement and make the subject unsuitable for
             enrollment, such as: uncontrolled active infections (CTCAE v5.0 grade 2), uncontrolled
             diabetes (fasting blood glucose >7.8 mmol/L despite optimal medical therapy),
             uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood
             pressure >100 mmHg despite optimal medical therapy), peripheral neuropathy ≥ grade 2
             (CTCAE v5.0), congestive heart failure ≥ grade 2 (CTCAE v5.0), myocardial infarction
             within the last 6 months, severe/unstable angina or coronary/peripheral artery bypass
             graft, arterial thromboembolism or deep vein thrombosis, stroke and/or transient
             ischemic attack, moderate to severe hepatic cirrhosis, uncontrolled major seizure
             disorders, known history of autoimmune disease that is active or may relapse (except
             for clinically stable hypothyroidism);
          8. Known active infection of human immunodeficiency virus (HIV) or hepatitis C virus
             (HCV);
          9. For hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive
             subjects, HBV DNA level above upper limit of reference range;
         10. Pregnant or lactating women;
         11. Severe psychological or psychiatric abnormalities that may affect compliance with
             study requirements;
         12. Detection of active or untreated CNS metastases on baseline imaging assessments by CT
             or MRI during screening: a) If new asymptomatic CNS metastases are detected on
             baseline scans, subjects must receive radiotherapy and/or surgery for CNS metastases,
             and can be enrolled without repeat CNS imaging if meeting all other criteria; b)
             Subjects with history of treated brain or meningeal metastases can be enrolled if
             clinically stable for at least 2 months and systemic high-dose corticosteroids (>10
             mg/day prednisone or equivalent) has been discontinued for at least 4 weeks.