Evaluating C019199 and Sintilimab for Advanced Solid Tumors

A Phase I/II Clinical Study on the Safety, Tolerability and Preliminary Efficacy of C019199 in Combination With Sintilimab in Patients With Advanced Solid Tumors

This study is testing a new combination of two drugs, C019199 and Sintilimab, to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: Sintilimab, prednisone
• Locations: 2 sites (Xiamen, Fujian and 1 other locations)
• Trial ID: NCT06220318 on ClinicalTrials.gov

What this trial studies

This clinical trial is a phase I/II non-randomized, open-label, single-arm study designed to assess the safety and efficacy of the drug combination C019199 and Sintilimab in patients with advanced solid tumors. In phase I, the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of C019199 will be determined. Phase II will focus on evaluating the safety and efficacy of this combination therapy in patients with specific solid tumors at the RP2D established in phase I.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with advanced solid tumors that have progressed on or are intolerant to standard treatments.

Not a fit: Patients with early-stage solid tumors or those who have not yet undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: While this approach is being explored in this specific combination, similar studies involving immunotherapy and targeted therapies have shown promising results in treating advanced solid tumors.

Eligibility criteria

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.

Where this trial is running

Xiamen, Fujian and 1 other locations

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Principal investigator: FENG YE — The First Affiliated Hospital of Xiamen University
• Study coordinator: JUNQING LI

Conditions: Solid Tumor