Clinical trial for Solid Tumor
Official title SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06873659
What this study is testing
What is SON-DP?
SON-DP is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female participants aged 18 to 75 years (inclusive).
- For Phase Ia: Participants with histologic diagnosis and confirmed solid tumor; For Phase Ib: Participants with one of the two tumor types: Group 1...
- There must be at least one measurable lesion defined by RECIST v1.1. Lesions intended for biopsy should generally not be selected as target lesions...
- The ECOG performance status ≤ 1.
- Able to understand and willing to sign the informed consent form (ICF) and comply with all the requirements of the protocol.
You likely can't join if
- Pregnant or breastfeeding women. Pregnancy is defined as the state from conception until the termination of pregnancy, confirmed by a positive human...
- Participation in an treatment, investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
- Presence of overt leptomeningeal or active central nervous system (CNS) metastases or primary tumors or CNS metastases that require local...
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA]...
- QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 ms ECG or congenital long QT syndrome at the Screening Visit, except...
See the full eligibility criteria
Who can join
- Male or female participants aged 18 to 75 years (inclusive).
- For Phase Ia: Participants with histologic diagnosis and confirmed solid tumor; For Phase Ib: Participants with one of the two tumor types: Group 1: advanced primary liver cancer; Group 2: Advanced primary gastric...
- There must be at least one measurable lesion defined by RECIST v1.1. Lesions intended for biopsy should generally not be selected as target lesions, unless the investigator assesses that the biopsy of the lesion will...
- The ECOG performance status ≤ 1.
- Able to understand and willing to sign the informed consent form (ICF) and comply with all the requirements of the protocol.
- The investigator assesses that the subject's expected lifespan is greater than 3 months.
- people must be candidates for and agree to the placement of a central venous access line and further must be able, in the opinion of the Investigator, to manage care of this line.
- people with treated brain metastases are allowed but should be neurologically stable (for 4 weeks post-treatment as assessed by CNS imaging and prior to study enrollment) and off steroids for at least 2 weeks before...
- All people in Phase Ia (with partial exceptions for the first 2 dose levels and designated people in Phase Ib must be prepared to undergo 2 or more tumor biopsies, one during the screening period and 1-2 biopsy during...
- Adequate hepatic/renal function as evidenced by meeting all the following requirements:
- Total bilirubin ≤ 1.5 × ULN except for people with Gilbert's syndrome who are excluded if TBIL \> 3.0×ULN or direct bilirubin \< 1.5×ULN. And there is no evidence of sustained liver function elevation (within 7 days) or...
- AST \< 3.0×ULN, except for people that have tumor involvement of the liver, who are included if AST ≤ 5×ULN. And there is no evidence of sustained liver function elevation (within 7 days) or acute hepatic...
- ALT ≤ 3.0×ULN, except for people that have tumor involvement of the liver, who are included if ALT ≤ 5×ULN. And there is no evidence of sustained liver function elevation (within 7 days) or acute hepatic decompensation...
- Blood Urea Nitrogen (BUN) \< 2.5×ULN.
- The calculated creatinine clearance (CrCL) using the Cockcroft-Gault formula must be ≥ 60 mL/min.
- Primary liver cancer: Child-Pugh class A or class B with a score of 7, and no history of hepatic encephalopathy.
- The subject must have adequate bone marrow function (no blood transfusions or hematopoietic growth factor support within 14 days prior to the first dose of SON-DP), with special circumstances to be jointly evaluated by...
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
- Hemoglobin (HGB) ≥ 80 g/L;
- Platelet count (PLT) ≥ 75 × 10⁹/L.。
- Coagulation tests within an acceptable range defined by the following:
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- International normalized ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN. Exception: INR 2 to ≤ 3 ULN is acceptable for people on stable therapeutic anticoagulants without active bleeding within 14 days prior to the...
- Toxicity related to previous antitumor treatments must have returned to baseline or ≤ grade 1 (NCI-CTCAE 5.0), except for toxicities judged by the investigator to pose no safety risk, such as: hair loss, ≤ grade 2...
- Female participants must agree not to breastfeed starting at screening and throughout the study period and for 90 days after final SON-DP administration.
- Fertile, eligible people (both male and female) must agree to use reliable contraception methods (hormonal, barrier methods, or abstinence) during the trial and for at least 90 days after the last dose of the medication.
What rules you out
- Pregnant or breastfeeding women. Pregnancy is defined as the state from conception until the termination of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. Unless one of the...
- Participation in an treatment, investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
- Presence of overt leptomeningeal or active central nervous system (CNS) metastases or primary tumors or CNS metastases that require local CNS-directed therapy (e.g., radiotherapy or surgery) or increasing doses of...
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Grade ≥ 2), left ventricular ejection fraction (LVEF) \< 50% as determined...
- QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 ms ECG or congenital long QT syndrome at the Screening Visit, except people with pacemaker.
- Acute myocardial infarction or unstable angina pectoris \< 6 months prior to study entry.
- Uncontrolled hypertension (systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg), or in the opinion of the Investigator: a recent history of hypertension crisis, or a recent history of hypertensive...
- History of stroke or clinically significant intracranial hemorrhage within 6 months before first dose of study drug.
- Concurrent severe pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or...
- Subject with active human immunodeficiency virus (HIV) infection or a history of HIV infection; people with active chronic hepatitis B or active chronic hepatitis C (excluding hepatitis B virus carriers, those with...
- Other primary malignancies, past or present, except for the enrollment indications of this study. However, this does not include: malignancies that have been cured within 2 years prior to the first dose of SON-DP with...
- The presence of clinically symptomatic, poorly controlled pleural effusion, pericardial effusion, or ascites that requires repeated drainage.
- Anticancer therapy within 5 half-lives or 3 weeks (whichever is shorter) prior to study entry. Chinese anticancer medicine, three weeks prior first dosing.
- Received radical radiation therapy or radiation to an area where the bone marrow proportion is greater than 30% within 4 weeks prior to the first dose of SON-DP. Exceptions include: palliative radiation therapy for...
- people receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10 mg/day prednisone or equivalent) two weeks prior first SON-DP dosing. Topical, inhaled, nasal, and ophthalmic steroids are allowed.
- The use of any live vaccines or live attenuated vaccines against infectious diseases within 4 weeks prior to the first dose of SON-DP and during the study treatment period.
- people with a history of stroke or having active neurological symptoms, with the exception of chronic conditions or sequelae which in the opinion of the neurologist, Investigator, and the Sponsor, would not impact...
- people who are using medications that cannot be used concurrently with urea; people who are using medications that require special caution or careful consideration when used with urea. Enrollment may be allowed if the...
- people with diseases affecting the thirst recognition center, such as central diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion (SIADH), etc.
- Active infection requiring intravenous systemic antibiotic or antiviral therapy within 14 days prior to the first dose of SON-DP.
- Major surgery within 4 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
- people who have undergone solid organ or hematopoietic stem cell transplantation within 5 years prior to signing the informed consent for this study.
- Any medical condition that would, in the Investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study...
- Allergy to study protein drug or components of its formulation such as PEI and urea.
- History of a Grade 3 to 4 allergic reaction to treatment with another protein product.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Nanjing, Jiangsu, China
- Xi'an, Shaanxi, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Nanjing, Jiangsu, China; Xi'an, Shaanxi, China; Jinan, Shandong, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.