Solid TumorPhase 1/2NCT06220318

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

A Phase 1/2 study testing C019199 and Sintilimab in people with Solid Tumor, run by Fujian Haixi Pharmaceuticals Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor
What is being tested?: C019199 and Sintilimab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 155 participants
Where: 2 sitesChina
Study dates: 19 Jul 2023to 30 Aug 2026
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 ;

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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.

Who cannot join

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;

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Hunan Cancer Hospital
Changsha, Hunan
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian

Other trials in China

About this study

Official title: 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 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.

Read the detailed description

Phase I will determine and confirm the maximum tolerated dose(MTD) and recommended phase II dose(RP2D) for C019199 in combination with 200 milligrams (mg) ( intravenous[IV], every 3 weeks [Q3W]) Sintilimab in patients with advanced Solid tumors.

Phase II will evaluate the safety and efficacy of the combination of C019199 and Sintilimab in selected solid tumors at the RP2D from Phase I.

Conditions: Solid Tumor
Being tested: C019199, Sintilimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C019199Drug
Also called C019199 Tablets
The C019199 will be taken orally, once a day
SintilimabDrug
Also called IBI308
Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.

Study groups in NCT06220318
Study group	Role	What they receive
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 . Receives: Drug: C019199; Drug: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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）
A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 28 days following the last dose of study drug,which does not necessarily have a causal relationship with the treatment. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria
Measured: From the first dose until 28 days after the last dose
Cmax
Maximum Plasma Concentration
Measured: Cycle 1 Day 1; Cycle 1 Day 21
AUC(0-t):
Area under the concentration-time curve (AUC)
Measured: Cycle 1 Day 1; Cycle 1 Day 21
T1/2
Terminal Half-life
Measured: Cycle 1 Day 1; Cycle 1 Day 21
Disease Control Rate (DCR) after administration
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.
Measured: From date of enrollment until the date of first documented progression or death
Duration of Remission (DoR) after administration
Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to iRECIST ) of the responders (who achieve PR or better response).se).
Measured: From date of enrollment until the date of first documented progression or death
Overall Survival (OS) after administration
OS is defined as the time from the date of study treatment to the date of death due to any cause .
Measured: The time from the date of enrollment until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 202330 Aug 2026

First posted23 Jan 2024
Study start19 Jul 2023
Primary completion30 Aug 2026 (estimated)
Study completion30 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: DRUG: C019199 The C019199 will be taken orally, once a day DRUG: Sintilimab Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.
Masking: None (open label)
Enrolment: 155 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06220318
Sponsor's protocol ID: HXP019-CTPI-02
Status last verified: Nov 2025
First submitted: 14 Jan 2024
Last updated: 28 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06220318
Acronym / sponsor ID: HXP019-CTPI-02
Conditions: Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 155 participants (estimated)
Lead sponsor: Fujian Haixi Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Jul 2023 (actual)
Primary completion: 30 Aug 2026 (estimated)
Study completion: 30 Aug 2026 (estimated)
First posted: 23 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Phase II will evaluate the safety and efficacy of the combination of C019199 and Sintilimab in selected solid tumors at the RP2D from Phase I.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: DRUG: C019199 The C019199 will be taken orally, once a day DRUG: Sintilimab Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.

Arm	Type	Receives
C019199 plus Sintilimab	Experimental	Drug: C019199, Drug: SintilimabPatients 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 .

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C019199Also: C019199 TabletsThe C019199 will be taken orally, once a day	Drug	C019199 plus Sintilimab
SintilimabAlso: IBI308Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.	Drug	C019199 plus Sintilimab

Primary outcome

Dose-Limiting Toxicity (DLT)
Time frame: Cycle 1 (Cycle length=21 days)
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.
Objective Response Rate (ORR) Based on iRECIST
Time frame: From date of enrollment until the date of first documented progression or death
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.
Progression-free Survival (PFS) after administration
Time frame: From date of enrollment until the date of first documented progression or death
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.

7 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events( TEAEs )and Serious Adverse Events （SAEs）
Time frame: From the first dose until 28 days after the last dose
Cmax
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
AUC(0-t):
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
T1/2
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
Disease Control Rate (DCR) after administration
Time frame: From date of enrollment until the date of first documented progression or death
Duration of Remission (DoR) after administration
Time frame: From date of enrollment until the date of first documented progression or death
Overall Survival (OS) after administration
Time frame: The time from the date of enrollment until death

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

FENG YE principal investigator

The First Affiliated Hospital of Xiamen University

YONGCHANG ZHANG principal investigator

Hunan Cancer Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing C019199 and Sintilimab in people with Solid Tumor, run by Fujian Haixi Pharmaceuticals Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Cycle 1 (Cycle length=21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.