Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors

NCT06220318 | Active Not Recruiting Phase 1

• 1 other identifier: HXP019-CTPI-02
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT)

  Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

  Cycle 1 (Cycle length=21 days)

• Objective Response Rate (ORR) Based on iRECIST

  ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions.

  From date of enrollment until the date of first documented progression or death

• Progression-free Survival (PFS) after administration

  Progression-free Survival (PFS) is defined as the time from the date of first dose of the study drug to the first documented disease progression (according to iRECIST ) or death (due to any cause), whichever occurs first.

  From date of enrollment until the date of first documented progression or death

Secondary Outcomes (7)

• Number of Participants With Treatment-emergent Adverse Events( TEAEs )and Serious Adverse Events （SAEs）

  From the first dose until 28 days after the last dose

• Cmax

  Cycle 1 Day 1; Cycle 1 Day 21

• AUC(0-t):

  Cycle 1 Day 1; Cycle 1 Day 21

• T1/2

  Cycle 1 Day 1; Cycle 1 Day 21

• Disease Control Rate (DCR) after administration

  From date of enrollment until the date of first documented progression or death

Study Arms (1)

C019199 plus Sintilimab

EXPERIMENTAL

Patients with selected tumors will received oral C019199 at a starting dose of 100mg once daily in combination with intravenous Sintilimab 200mg every 3 weeks ( Q3W ) on a 21-day treatment cycle until disease progression, development of unacceptable toxicity, or withdrawal of consent .

Drug: C019199; Drug: Sintilimab

Interventions

C019199 DRUG

The C019199 will be taken orally, once a day

Also known as: C019199 Tablets

C019199 plus Sintilimab

Sintilimab DRUG

Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.

Also known as: IBI308

C019199 plus Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age ≥18 years and \<76 years at the time of signing informed consent, male or female;
• 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;
• ECOG score: 0-1;
• Life expectancy of 3 months or more;
• Phase II: have measurable disease based on RECIST 1.1 ;
• Phase II: agree to provide archival tumor tissue or newly obtained biopsy of a tumor lesion ;
• Have adequate organ function ;
• 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 ;
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.

You may not qualify if:

• Subjects meeting any of the following criteria must be excluded from this study:
• Known hypersensitivity to CSF-1R inhibitors or Sintilimab;
• Receipt of (or planned receipt of) anti-tumor therapies within 4 weeks prior to first dose through the end of the study treatment period;
• 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);
• 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);
• Major surgery (grade III or IV surgery) within 4 weeks prior to first dose without complete recovery;
• 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;
• 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);
• Known active infection of human immunodeficiency virus (HIV) or hepatitis C virus (HCV);
• For hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive subjects, HBV DNA level above upper limit of reference range;
• Pregnant or lactating women;
• Severe psychological or psychiatric abnormalities that may affect compliance with study requirements;
• 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.

Sponsors & Collaborators

• Fujian Haixi Pharmaceuticals Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

MeSH Terms

Interventions

sintilimab

Study Officials

• FENG YE

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• YONGCHANG ZHANG

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: DRUG: C019199 The C019199 will be taken orally, once a day DRUG: Sintilimab Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: July 19, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)