SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors

NCT06873659 | Recruiting Phase 1

• 1 other identifier: SON-DP-A003-ST
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Solid Tumor; Gastric Cancer; Liver Cancer

Keywords

SON-DP; Solid Tumor; Gastric Cancer; Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with AEs, with abnormal vital signs, abnormal ECG readings, abnormal clinical laboratory tests results, abnormal physical examinations and abnormal ECOG performance status.

  Up to 7 months after the first dose

• MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)

  28 days post first administration of SON-DP

Secondary Outcomes (11)

• ORR

  Up to 6 months after the first dose. Up to 9 months if treated for 9 cycles.

• DCR

  Up to 6 months after the first dose

• TTP

  Up to 6 months after the first dose

• DOR

  Up to 6 months after the first dose

• PFS

  Up to 6 months after the first dose

Other Outcomes (1)

• SON-DP concentration in tumor biopsy tissue

  Up to 5 weeks after the first dose

Study Arms (8)

Dose escalation, Cohort 1

EXPERIMENTAL

SON-DP 3 or 6 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion in the cohort 1 at 2mg/kg dose level once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 2

EXPERIMENTAL

SON-DP 3 or 6 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion in the cohort 2 at 3mg/kg dose level once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 3

EXPERIMENTAL

SON-DP 3 or 6 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion in the cohort 3 at 4.5mg/kg dose level once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 4

EXPERIMENTAL

SON-DP 3 or 6 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion in the cohort 4 at 6mg/kg dose level once per week in 28-day cycle, for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 5

EXPERIMENTAL

SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion at the RP2D-1 dose level once per week for up to 6 cycles.

Drug: SON-DP

Dose escalation, Cohort 6

EXPERIMENTAL

SON-DP Up to 12 participants with solid tumor will be treated with SON-DP by 150-minute IV infusion at the RP2D dose level once per week for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 1

EXPERIMENTAL

SON-DP Up to 24 participants with advanced primary gastric cancer will be treated with SON-DP by 150-minute IV infusion at the RP2D dose level once per week for up to 6 cycles.

Drug: SON-DP

Dose expansion, Arm 2

EXPERIMENTAL

SON-DP Up to 24 participants with advanced primary liver cancer will be treated with SON-DP by 1500-minute IV infusion at the RP2D dose level once per week for up to 6 cycles.

Drug: SON-DP

Interventions

SON-DP DRUG

Solution for IV administration

Dose escalation, Cohort 1; Dose escalation, Cohort 2; Dose escalation, Cohort 3; Dose escalation, Cohort 4; Dose escalation, Cohort 5; Dose escalation, Cohort 6; Dose expansion, Arm 1; Dose expansion, Arm 2

Eligibility Criteria

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

You may qualify 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: advanced primary liver cancer; Group 2: Advanced primary gastric cancer (including gastroesophageal junction adenocarcinoma).
• 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 not affect subsequent tumor evaluations. Lesions that have previously undergone radiation therapy, interventional therapy, or other local treatments should generally not be selected as target lesions, unless the lesion shows clear radiological progression after local treatment.
• 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.
• Subjects 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.
• Subjects 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 administration of any study treatment.
• All subjects in Phase Ia (with partial exceptions for the first 2 dose levels and designated subjects in Phase Ib must be prepared to undergo 2 or more tumor biopsies, one during the screening period and 1-2 biopsy during therapy. In the Investigator's assessment, these biopsies should be feasible considered, safe by the investigator, and not expected to interfere with all other study assessments.
• Adequate hepatic/renal function as evidenced by meeting all the following requirements:
• Total bilirubin ≤ 1.5 × ULN except for subjects 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 acute hepatic decompensation, as assessed by the investigator.
• AST \< 3.0×ULN, except for subjects 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 decompensation, as assessed by the investigator.
• ALT ≤ 3.0×ULN, except for subjects 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, as assessed by the investigator.
• Blood Urea Nitrogen (BUN) \< 2.5×ULN.
• The calculated creatinine clearance (CrCL) using the Cockcroft-Gault formula must be ≥ 60 mL/min.

You may not qualify if:

• 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 following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or documented biological or physiological evidence of postmenopausal status (defined as no menstruation for more than 12 months without other conditions), or women who have been menopausal for 6-12 months must have a serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL to confirm menopause; otherwise, female subjects will be considered fertile.
• Participation in an interventional, 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 corticosteroids within the prior 2 weeks.
• 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 by multiple gated acquisition (MUGA) or echocardiogram (ECHO), uncontrolled hypertension, or clinically significant arrhythmia.
• QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 ms ECG or congenital long QT syndrome at the Screening Visit, except subjects 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 encephalopathy.
• 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 pneumonia considered based on imaging examination or investigator assessment at screening, as well as a history of non-infectious pneumonia requiring steroid treatment within 12 months prior to signing informed consent.
• Subject with active human immunodeficiency virus (HIV) infection or a history of HIV infection; subjects with active chronic hepatitis B or active chronic hepatitis C (excluding hepatitis B virus carriers, those with stable hepatitis B after antiviral treatment \[HBV DNA negative/ below the lower limit of detection in hospital's quantitative testing or \< 500 IU/mL\], and HCV-Ab positive but HCV-RNA negative subjects); subject with active syphilis.
• 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 no signs of recurrence, fully treated and completely resected cervical carcinoma in situ, completely resected skin basal cell carcinoma or squamous cell carcinoma, any malignancy considered indolent and not requiring treatment, or any type of carcinoma in situ that has been completely resected.
• 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 localized lesions (e.g., radiation therapy for bone lesions aimed at symptom relief) or local interventional treatments (such as transarterial chemoembolization \[TACE\] and others) assessed by the investigator as posing no safety risks.

Sponsors & Collaborators

• Qurgen Inc.: lead

Study Sites (11)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Introduction to Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, 250117, China

RECRUITING

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases

Central Study Contacts

Jianjun Wang

CONTACT

+1 (248)607 8451; sponsor-qurgen-mm@qurgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential assignment and dose expansion of RP2D in selected tumor types. This is an open-label clinical trial for patients with advanced solid tumors. The design follows an accelerated titration combined with the traditional 3+3 dose escalation rule to ensure the safety of the participants, while also obtaining key information about SON-DP when administering it to subjects who have signed informed consent. In order to minimize the number of participants in dose groups with limited antitumor activity but relatively low toxic side effects. Since the primary objective of this study is to gather information on the antitumor activity of SON-DP and determine the RP2D (Recommended Phase 2 Dose), various methods to assess drug activity have been designed to evaluate the safety, antitumor efficacy, and RP2D of the product.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)