Non-Small Cell Lung CancerPhase 1/2NCT05278364
Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor
A Phase 1/2 study testing SY-5007 in people with Non-Small Cell Lung Cancer and Medullary Thyroid Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 2 sites in China.
Trial summary
This is a phase I/II, open-label, multi-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of SY-5007 administered orally to participants with advanced solid tumors, including RET Fusion-Positive NSCLC or RET-mutated MTC or other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Solid Tumor
- What is being tested?
- SY-5007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesChina
- Study dates
- 23 Apr 2021to 10 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- -
- For Phase I:
- Male or female, at least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Estimated life expectancy >12 weeks.
- Patients must have at least one assessable lesion in dose-escalation part and one measurable lesion in dose-expansion part per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Show all 26Show fewer
- Dose-escalation Part: patients must have histological or cytological confirmed advanced solid tumours with RET alteration (fusion or mutation) and have progressed after standard therapy, or no standard or available curative therapy exists.
- Dose-expansion Part: Patients with advanced tumor must have histological or cytological confirmed RET alteration, including NSCLC patients with RET-fusion or MTC patients with RET-mutation or other patients with RET alteration, and either have progressed after standard therapy or no standard/ available curative therapy exists.
- Patients must have adequate organ function as defined in the below:
- Hepatic function:
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) if no hepatic metastases are present, or otherwise ≤ 5 times ULN, Total serum bilirubin (TBIL) ≤ 1.5 times ULN.
- Bone marrow function (No blood transfusion or haematopoietic stimulating factor treatment within 10 days prior to testing):
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L; Platelets (PLT) count ≥ 75 x 10⁹/L; Hemoglobin (Hb) ≥ 85 g/L.
- Renal function:
- Creatinine clearance ≥ 50 mL/min.
- Coagulation function:
- Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.5 times ULN.
- Serum lipid:
- Cholesterol ≤ 500mg/dL（12.92mmol/L）.
- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose, male and female patients of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception during the entire study duration and for at least 3 months after the last dose of study medication.
- Willingness and ability to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
- For Phase II: As for phase I with the following modifications:
- Participants must have histological or cytological confirmed locally advanced or metastatic RET Fusion-Positive NSCLC, have progressed following platinum-based chemotherapy and/or PD-1/PD-L1 immunotherapy, or have not received prior systemic therapy, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy.
- The participants' tumor tissue or blood sample test results meet 1 of the following 2 criteria:
- Previous tumor tissue or blood sample confirmed positive for RET fusion by local laboratory.
- If no previous positive RET fusion test report is available, a compliant tumor tissue or blood sample must be tested at a central laboratory designated by the sponsor, using a second-generation sequencing (NGS)-based assay, and confirmed as positive for RET fusion.
Who cannot join
- Dose-expansion Part: Patient's cancer has a known primary driver alteration other than RET. e.g. EGFR, ALK, ROS1, KRAS, etc.
- Dose-expansion Part: Patients previously treated with a selective RET inhibitor.
- Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following:
- Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks.
- Patients received other unlisted clinical trial drugs or treatments within 4 weeks prior to the first dose.
- Patients underwent major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks prior to the first dose.
Show all 24Show fewer
- Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.)
- Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms.
- Patients with active uncontrolled systemic bacterial, viral, or fungal infection despite optimal treatment (chronic disease screening not required).
- Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA ≥ 1000 IU/ml), HIV antibody-positive; Active syphilis.
- Patients have a history of severe cardiovascular disease, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, e.g. ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.
- Mean QT interval corrected using Fridericia's formula (QTcF)> 480ms at rest. Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke or other grade 3 or higher cardiovascular or cerebrovascular events within 6 months prior to the first dose.
- New York Heart Association (NYHA) ≥ class II heart failure or left ventricular ejection fraction (LVEF) < 50%.
- Hypertension remains uncontrolled after aggressive antihypertensive therapy.
- Patients have been treated with any CYP3A inhibitors or inducers within 14 days prior to the first dose.
- Patients with malignancies other than tumors treated in this study (except: malignancies that are cured and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type).
- Patients are unable to swallow the drug orally, or has a condition that seriously affects gastrointestinal absorption in the judgment of the investigator.
- For Phase II: As for phase I with the following modifications:
- Patients received any selective RET inhibitor (including marketed drugs such as selpercatinib, pralsetinib, and unmarketed experimental drugs).
- Patients have a history of hypersensitivity to any component or excipient of SY-5007 capsule.
- Patients participated in another clinical study within 4 weeks prior to the first dose or is scheduled to participate in another clinical study during the study period.
- Pregnant or breastfeeding female patients.
- Other conditions deemed by the investigator to be inappropriate for participation in this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, PhD, 13301825532, caicunzhoudr@163.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300000
Ming Gao, PhD, Headandneck2008@126.com
About this study
Official title: A Phase I/II, Open-Label, Single-arm, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of SY-5007 in Patients With RET-altered Advanced Solid Tumor.
This is a phase I/II, open-label, multi-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of SY-5007 administered orally to participants with advanced solid tumors, including RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor.
Read the detailed description
The study consists of 2 parts:
Part 1: Dose-escalation and dose-expansion in patients with RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor. Dose-escalation study phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of SY-5007. Dose-expansion study phase is designed to evaluate the antitumor activity (ORR, DCR and DoR) of SY-5007 in patients.
Part 2: Phase II study to evaluate the antitumor efficacy of SY-5007. Patients with advanced RET Fusion-Positive NSCLC will be enrolled in this phase. SY-5007 will be administered orally 160mg twice daily in a 28-day cycle. This phase is designed to determine the antitumor activity (ORR, DCR, DoR, PFS and OS), safety, and PK of SY-5007.
- Being tested
- SY-5007
- Keywords
- SY-5007, RET-fusion positive NSCLC, RET-mutant MTC, RET-altered advanced solid tumor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-5007Drug
Also called SY-5007 Capsule
a RET selective Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation and Dose-expansion | Experimental | Dose-escalation Phase:
Multiple doses of SY-5007 for oral administration.
Dose Expansion Phase:
RP2D of SY-5007 as determined during Dose Escalation. Receives: Drug: SY-5007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine the dose-limiting toxicities (DLT) during the first 28-day cycle of SY-5007 treatment
Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) in Cycle 1
Measured: Dose-escalation Cycle 1 (each cycle is 28 days)
Phase I: Number of patients with adverse events and serious adverse events
Characterization of the safety and tolerability
Measured: Up to 24 months
Phase II: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Anti-tumor activity of SY-5007
Measured: Up to 24 months
Secondary outcomes (10)
Phase I: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteriaOverall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Preliminary anti-tumor activity of SY-5007
Measured: Up to 24 months
Phase I & II: Disease control rate (DCR) as assessed by RECIST 1.1 criteria
Preliminary anti-tumor activity of SY-5007
Measured: Up to 24 months
Phase I & II: Duration of response (DOR)
Preliminary anti-tumor activity of SY-5007
Measured: Up to 24 months
Phase I & II: Progression Free Survival (PFS)
Preliminary anti-tumor activity of SY-5007
Measured: Up to 24 months
Phase I & II: Overall survival (OS)
Anti-tumor activity of SY-5007
Measured: Up to 24 months
Phase I & II: Percentage of Participants with any Serious Adverse Events (SAEs)
Characterization of the safety and tolerability
Measured: Up to 24 months
Phase I & II: Pharmacokinetic Parameters Including Maximum Plasma Drug Concentration (Cmax)
Cmax of SY-5007
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including time to maximum plasma concentration (Tmax) of SY-5007
Tmax of SY-5007
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including Area Under the Plasma Concentration-Time Curve of SY-5007 (AUC)
AUC of SY-5007
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including Terminal Elimination Half-life (t1/2) of SY-5007
plasma terminal phase disposition half-life of SY-5007
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start23 Apr 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion10 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghui Sun, PhD, Study director, Shouyao Holdings (Beijing) Co. LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278364
- Sponsor's protocol ID
- SY-5007-I
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li W, Wang Y, Xiong A, Gao G, Song Z, Zhang Y, Huang D, Ye F, Wang Q, Li Z, Liu J, Xu C, Sun Y, Liu X, Zhou F, Zhou C. First-in-human, phase 1 dose-escalation and dose-expansion study of a RET inhibitor SY-5007 in patients with advanced RET-altered solid tumors. Signal Transduct Target Ther. 2024 Nov 4;9(1):300. doi: 10.1038/s41392-024-02006-9.
PubMed 39489747
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Single-arm, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of SY-5007 in Patients With RET-altered Advanced Solid Tumor.
- ClinicalTrials.gov ID
- NCT05278364
- Acronym / sponsor ID
- SY-5007-I
- Keywords
- SY-5007, RET-fusion positive NSCLC, RET-mutant MTC, RET-altered advanced solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 14 Mar 2022 (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, open-label, multi-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of SY-5007 administered orally to participants with advanced solid tumors, including RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor.
Detailed description
The study consists of 2 parts:
Part 1: Dose-escalation and dose-expansion in patients with RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor. Dose-escalation study phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of SY-5007. Dose-expansion study phase is designed to evaluate the antitumor activity (ORR, DCR and DoR) of SY-5007 in patients.
Part 2: Phase II study to evaluate the antitumor efficacy of SY-5007. Patients with advanced RET Fusion-Positive NSCLC will be enrolled in this phase. SY-5007 will be administered orally 160mg twice daily in a 28-day cycle. This phase is designed to determine the antitumor activity (ORR, DCR, DoR, PFS and OS), safety, and PK of SY-5007.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation and Dose-expansion | Experimental | Drug: SY-5007Dose-escalation Phase: Multiple doses of SY-5007 for oral administration. Dose Expansion Phase: RP2D of SY-5007 as determined during Dose Escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- -
- Male or female, at least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Estimated life expectancy >12 weeks.
- Patients must have at least one assessable lesion in dose-escalation part and one measurable lesion in dose-expansion part per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key exclusion criteria (24 listed)
- Dose-expansion Part: Patient's cancer has a known primary driver alteration other than RET. e.g. EGFR, ALK, ROS1, KRAS, etc.
- Dose-expansion Part: Patients previously treated with a selective RET inhibitor.
- Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following:
- Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks.
- Patients received other unlisted clinical trial drugs or treatments within 4 weeks prior to the first dose.
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 |
|---|---|---|
| SY-5007Also: SY-5007 Capsulea RET selective Inhibitor | Drug | Dose-escalation and Dose-expansion |
Primary outcome
Phase I: Determine the dose-limiting toxicities (DLT) during the first 28-day cycle of SY-5007 treatment
Time frame: Dose-escalation Cycle 1 (each cycle is 28 days)
Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) in Cycle 1
Phase I: Number of patients with adverse events and serious adverse events
Time frame: Up to 24 months
Characterization of the safety and tolerability
Phase II: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Anti-tumor activity of SY-5007
10 secondary outcomes
Phase I: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteriaOverall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Phase I & II: Disease control rate (DCR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Phase I & II: Duration of response (DOR)
Time frame: Up to 24 months
Phase I & II: Progression Free Survival (PFS)
Time frame: Up to 24 months
Phase I & II: Overall survival (OS)
Time frame: Up to 24 months
Phase I & II: Percentage of Participants with any Serious Adverse Events (SAEs)
Time frame: Up to 24 months
Phase I & II: Pharmacokinetic Parameters Including Maximum Plasma Drug Concentration (Cmax)
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including time to maximum plasma concentration (Tmax) of SY-5007
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including Area Under the Plasma Concentration-Time Curve of SY-5007 (AUC)
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Phase I & II: Pharmacokinetic Parameters Including Terminal Elimination Half-life (t1/2) of SY-5007
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 39489747Li W, Wang Y, Xiong A, Gao G, Song Z, Zhang Y, Huang D, Ye F, Wang Q, Li Z, Liu J, Xu C, Sun Y, Liu X, Zhou F, Zhou C. First-in-human, phase 1 dose-escalation and dose-expansion study of a RET inhibitor SY-5007 in patients with advanced RET-altered solid tumors. Signal Transduct Target Ther. 2024 Nov 4;9(1):300. doi: 10.1038/s41392-024-02006-9.
Related trials for Non-Small Cell Lung Cancer
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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Yinghui Sun, PhD study director
Shouyao Holdings (Beijing) Co. LTD
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 SY-5007 in people with Non-Small Cell Lung Cancer and Medullary Thyroid Cancer, run by Shouyao Holdings (Beijing) 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 26 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinghui Sun, PhD (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Determine the dose-limiting toxicities (DLT) during the first 28-day cycle of SY-5007 treatment (time frame: Dose-escalation Cycle 1 (each cycle is 28 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 NCT05278364, which also lists 1 linked publication.
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 12 Apr 2023.