Non-Small Cell Lung Cancer With EGFR MutationPhase 1NCT06641609
A Phase I Study of CFT8919 in Patients With Advanced NSCLC
A Phase 1 study testing Dose-Escalation (Phase Ia) CFT8919 capsule, Dose-Expansion (Phase Ib) CFT8919 capsule and Cohort-Expansion (Phase Ic) CFT8919 capsule in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer With EGFR Mutation
- What is being tested?
- Dose-Escalation (Phase Ia) CFT8919 capsule, Dose-Expansion (Phase Ib) CFT8919 capsule and Cohort-Expansion (Phase Ic) CFT8919 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to Dec 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose-Escalation and Dose-Expansion Phases: Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack standard treatment options, or are deemed unsuitable for standard treatment by the investigator, or have refused standard treatment.
- Cohort-Expansion Phase: In addition to the above criteria, the following must also be met:
- Cohort A: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have experienced disease progression after third-generation EGFR-TKI treatment and carry secondary EGFR mutations (such as C797S, L718Q, G724S, S768I, etc.).
- Cohort B: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have failed standard treatment or are unsuitable for or have refused standard treatment (patients with secondary EGFR mutations are prioritized for Cohort A).
- • Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.
- • Age ≥18 years, no gender restrictions.
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- • Expected survival ≥12 weeks.
- • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- • Adequate organ function, meeting the following criteria:
- Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/mm³), platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL (90 g/L) without transfusion or hematopoietic growth factors within 14 days prior to screening.
- Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).
- Liver: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in the presence of liver metastases; total bilirubin (TBIL) ≤1.5 × ULN, or ≤3.0 × ULN in the presence of liver metastases or known Gilbert\'s syndrome (unconjugated hyperbilirubinemia).
- Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or for patients with Scr \>1.5 × ULN, creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft-Gault formula); urine protein ≤1+, or if ≥2+, 24-hour urine protein quantification showing \<1 g.
- • Toxicity from prior anti-tumor treatments must have resolved to CTCAE grade ≤1 (except for toxicities that, in the investigator\'s judgment, are long-lasting and non-recoverable but pose no safety risk and are ≤2 in grade).
- • Patients must have been previously diagnosed with the EGFR-L858R mutation via local testing. In the Dose-Escalation and Dose-Expansion Phases, patients who progressed on prior EGFR-TKI treatment must provide the genetic mutation results from their most recent EGFR-TKI treatment. For Cohort A patients, progression on third-generation EGFR-TKI treatment must have confirmed the presence of secondary EGFR mutations (e.g., C797S, L718Q, G724S, S768I) via tissue or blood tests.
- • Patients must be willing to provide blood samples and optionally provide tissue samples for exploratory biomarker research.
- • Non-breastfeeding women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before starting study treatment, and all enrolled patients must agree to use medically accepted contraception for 1 month prior to treatment, during the entire treatment period, and for 3 months after completing treatment.
- • Signed informed consent form.
Who cannot join
- Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.
- Less than 5 half-lives or 4 weeks (whichever is shorter) since the last anti-tumor treatment before the first dose of study drug; less than 6 weeks since the last treatment with nitrosoureas or mitomycin C; less than 1 week since the last anti-tumor herbal treatment.
- Patients who underwent major surgery (as defined by the investigator) or experienced significant trauma within 4 weeks before the first dose of study drug; patients who received radiation therapy within 4 weeks prior to the first dose, except for palliative radiation (e.g., for bone metastases to control pain) that is unlikely to affect bone marrow function, which may allow inclusion 2 weeks post-radiation.
- Patients with unstable central nervous system (CNS) metastases (those who have received treatment for brain metastases, have stable brain lesions, and have discontinued corticosteroids, anticonvulsants, or mannitol treatment for ≥2 weeks before the first dose may be considered for inclusion); patients with leptomeningeal metastases or spinal cord compression.
- History of other primary malignancies within the past 3 years, except for malignancies that have been treated curatively with no known active disease and a low risk of recurrence, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.
- Clinically significant cardiovascular diseases, including but not limited to:
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- a) Unstable angina, acute myocardial infarction, or New York Heart Association (NYHA) class II-IV heart failure;
- b) Ventricular arrhythmias or conduction disorders requiring clinical intervention (e.g., complete left bundle branch block, third-degree atrioventricular [AV] block, or second-degree AV block);
- c) Uncontrolled atrial fibrillation or atrial flutter;
- d) Prolonged QTcF interval (resting mean QTcF \>450 msec for men or \>470 msec for women);
- e) Left ventricular ejection fraction (LVEF) \<50% on echocardiography;
- f) Hypertension not controlled with medication.
- • History of interstitial lung disease (ILD) or non-infectious pneumonitis.
- • Adrenal insufficiency.
- • Use of proton pump inhibitors, strong CYP3A4 inhibitors or inducers, or P-glycoprotein inhibitors or inducers within 7 days before the first dose.
- • History of chronic diarrhea or diseases causing chronic diarrhea, such as Crohn\'s disease or irritable bowel syndrome, or any condition that might affect drug absorption (e.g., continuous diarrhea \>CTCAE grade 1 within 1 week prior to the first dose).
- • Known severe hypersensitivity to the study drug or any of its excipients.
- • History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic events within 6 months before the first dose, except for catheter-related or superficial venous thrombosis, or lacunar infarcts.
- • Clinically significant gastrointestinal bleeding or hemoptysis within 3 months before the first dose, or any other significant bleeding history (e.g., pulmonary hemorrhage).
- • Clinically significant third-space fluid accumulation (e.g., uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage).
- • Receipt of autologous transplantation within 3 months or allogeneic organ or stem cell transplantation within 6 months prior to the first dose.
- • Active hepatitis B virus (HBV) infection (screening positive for HBsAg or anti-HBc, and HBV DNA levels above the detection limit; patients with stable disease for at least 4 weeks after antiviral therapy may be included), active hepatitis C virus (HCV) infection (positive HCV antibodies and detectable HCV RNA), human immunodeficiency virus (HIV) infection, or active syphilis infection.
- • Active infection requiring systemic treatment within 1 week before the first dose.
- • History of substance abuse or any condition that, in the investigator\'s judgment, may interfere with study participation or assessment of study results, or any unstable condition that may compromise patient safety or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yun Fan
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are:
- What is the maximum tolerated dose (MTD) of CFT8919?
- Does CFT8919 demonstrate antitumor activity in these patients?
Participants will:
- Take CFT8919 capsules at different doses.
- Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.
Read the detailed description
This is a Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who carry EGFR mutations. The study includes three parts: dose-escalation, dose-expansion, and cohort-expansion. The primary objectives are to determine the maximum tolerated dose (MTD) in the dose-escalation phase and to assess the antitumor efficacy in the cohort-expansion phase. Secondary objectives include assessing pharmacokinetic parameters, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will evaluate biomarkers and the relationship between drug exposure and treatment outcomes.
- Being tested
- Dose-Escalation (Phase Ia) CFT8919 capsule, Dose-Expansion (Phase Ib) CFT8919 capsule, Cohort-Expansion (Phase Ic) CFT8919 capsule
- Keywords
- Non-small cell lung cancer, EGFR mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-Escalation (Phase Ia) CFT8919 capsuleDrug
Also called CFT8919
Phase 1a，enrolled, eligible patients receive CFT8919 150-900mg twice daily.
Dose-Expansion (Phase Ib) CFT8919 capsuleDrug
Also called CFT8919
Phase 1b，enrolled, eligible patients receive CFT8919 RP2D twice daily.
Cohort-Expansion (Phase Ic) CFT8919 capsuleDrug
Also called CFT8919
Phase 1c，enrolled, eligible patients receive CFT8919 RP2D twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation (Phase Ia) | Experimental | Intervention Name: CFT8919 capsule Intervention Type: Drug Intervention Description: Participants will receive CFT8919 at different dose levels in a "3+3" dose-escalation design, starting from 150 mg BID, increasing to 300 mg, 600 mg, and up to 900 mg BID. Receives: Drug: Dose-Escalation (Phase Ia) CFT8919 capsule |
| Dose-Expansion (Phase Ib) | Experimental | After the MTD is determined in Phase Ia, participants will receive CFT8919 at the recommended Phase II dose (RP2D). The primary objective is to further evaluate the safety and preliminary antitumor activity of the drug at the RP2D Receives: Drug: Dose-Expansion (Phase Ib) CFT8919 capsule |
| Cohort-Expansion (Phase Ic) | Experimental | Participants will be enrolled based on their EGFR mutation status into separate cohorts. Each cohort will receive CFT8919 at the RP2D to evaluate its efficacy, safety, and pharmacokinetic profile in specific EGFR mutation populations, including those with L858R and other EGFR-resistant mutations after EGFR-TKI treatment. Receives: Drug: Cohort-Expansion (Phase Ic) CFT8919 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of participants who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Measured: up to 104 weeks
Maximum Tolerated Dose (MTD)
The highest dose at which no more than one of six participants experiences dose-limiting toxicity (DLT).
Measured: Determined at the end of the dose-escalation phase，an average of 1 year
Recommended Phase II Dose (RP2D)
The dose selected for Phase II studies based on safety, tolerability, and efficacy data.
Measured: Determined at the end of the dose-expansion，an average of 2 years
Secondary outcomes (5)
Dose-Limiting Toxicities (DLTs)
The occurrence of adverse events that prevent further dose escalation.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Safety and Tolerability
Assessed by the frequency, type, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From the start of treatment until 28 days after the last dose
Peak Plasma Concentration (Cmax)
The maximum observed concentration of the drug in plasma.
Measured: Up to approximately 30 months
Time to Reach Maximum Concentration (Tmax)
The time at which Cmax is observed
Measured: Up to approximately 30 months.
Half-Life (t1/2)
The time required for the plasma concentration of the drug to decrease by half.
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Nov 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer With EGFR MutationStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yun fan, PHD, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641609
- Sponsor's protocol ID
- BTP-662212
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT06641609
- Acronym / sponsor ID
- BTP-662212
- Keywords
- Non-small cell lung cancer, EGFR mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Oct 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.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are:
- What is the maximum tolerated dose (MTD) of CFT8919?
- Does CFT8919 demonstrate antitumor activity in these patients?
Participants will:
- Take CFT8919 capsules at different doses.
- Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.
Detailed description
This is a Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who carry EGFR mutations. The study includes three parts: dose-escalation, dose-expansion, and cohort-expansion. The primary objectives are to determine the maximum tolerated dose (MTD) in the dose-escalation phase and to assess the antitumor efficacy in the cohort-expansion phase. Secondary objectives include assessing pharmacokinetic parameters, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will evaluate biomarkers and the relationship between drug exposure and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation (Phase Ia) | Experimental | Drug: Dose-Escalation (Phase Ia) CFT8919 capsuleIntervention Name: CFT8919 capsule Intervention Type: Drug Intervention Description: Participants will receive CFT8919 at different dose levels in a "3+3" dose-escalation design, starting from 150 mg BID, increasing to 300 mg, 600 mg, and up to 900 mg BID. |
| Dose-Expansion (Phase Ib) | Experimental | Drug: Dose-Expansion (Phase Ib) CFT8919 capsuleAfter the MTD is determined in Phase Ia, participants will receive CFT8919 at the recommended Phase II dose (RP2D). The primary objective is to further evaluate the safety and preliminary antitumor activity of the drug at the RP2D |
| Cohort-Expansion (Phase Ic) | Experimental | Drug: Cohort-Expansion (Phase Ic) CFT8919 capsuleParticipants will be enrolled based on their EGFR mutation status into separate cohorts. Each cohort will receive CFT8919 at the RP2D to evaluate its efficacy, safety, and pharmacokinetic profile in specific EGFR mutation populations, including those with L858R and other EGFR-resistant mutations after EGFR-TKI treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Dose-Escalation and Dose-Expansion Phases: Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack standard treatment options, or are deemed unsuitable for standard treatment by the investigator, or have refused standard treatment.
- Cohort-Expansion Phase: In addition to the above criteria, the following must also be met:
- • Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.
- • Age ≥18 years, no gender restrictions.
- • Expected survival ≥12 weeks.
Key exclusion criteria (24 listed)
- Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.
- Less than 5 half-lives or 4 weeks (whichever is shorter) since the last anti-tumor treatment before the first dose of study drug; less than 6 weeks since the last treatment with nitrosoureas or mitomycin C; less than 1 week since the last anti-tumor herbal treatment.
- Patients who underwent major surgery (as defined by the investigator) or experienced significant trauma within 4 weeks before the first dose of study drug; patients who received radiation therapy within 4 weeks prior to the first dose, except for palliative radiation (e.g., for bone metastases to control pain) that is unlikely to affect bone marrow function, which may allow inclusion 2 weeks post-radiation.
- Patients with unstable central nervous system (CNS) metastases (those who have received treatment for brain metastases, have stable brain lesions, and have discontinued corticosteroids, anticonvulsants, or mannitol treatment for ≥2 weeks before the first dose may be considered for inclusion); patients with leptomeningeal metastases or spinal cord compression.
- History of other primary malignancies within the past 3 years, except for malignancies that have been treated curatively with no known active disease and a low risk of recurrence, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.
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 |
|---|---|---|
| Dose-Escalation (Phase Ia) CFT8919 capsuleAlso: CFT8919Phase 1a，enrolled, eligible patients receive CFT8919 150-900mg twice daily. | Drug | Dose-Escalation (Phase Ia) |
| Dose-Expansion (Phase Ib) CFT8919 capsuleAlso: CFT8919Phase 1b，enrolled, eligible patients receive CFT8919 RP2D twice daily. | Drug | Dose-Expansion (Phase Ib) |
| Cohort-Expansion (Phase Ic) CFT8919 capsuleAlso: CFT8919Phase 1c，enrolled, eligible patients receive CFT8919 RP2D twice daily. | Drug | Cohort-Expansion (Phase Ic) |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 104 weeks
The percentage of participants who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Maximum Tolerated Dose (MTD)
Time frame: Determined at the end of the dose-escalation phase，an average of 1 year
The highest dose at which no more than one of six participants experiences dose-limiting toxicity (DLT).
Recommended Phase II Dose (RP2D)
Time frame: Determined at the end of the dose-expansion，an average of 2 years
The dose selected for Phase II studies based on safety, tolerability, and efficacy data.
5 secondary outcomes
Dose-Limiting Toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety and Tolerability
Time frame: From the start of treatment until 28 days after the last dose
Peak Plasma Concentration (Cmax)
Time frame: Up to approximately 30 months
Time to Reach Maximum Concentration (Tmax)
Time frame: Up to approximately 30 months.
Half-Life (t1/2)
Time frame: Up to approximately 30 months
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
yun fan, PHD study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose-Escalation (Phase Ia) CFT8919 capsule, Dose-Expansion (Phase Ib) CFT8919 capsule and Cohort-Expansion (Phase Ic) CFT8919 capsule in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Betta Pharmaceuticals Co., Ltd. at 1 site 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 18 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
Contact yun fan, PHD (86-0571-88122092 ext. 3180, fanyun@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 104 weeks). 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?
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 4 Sep 2026.