DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
NCT ID: NCT07035249
Last Updated: 2025-07-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-07-15
Study Completion Date
2027-07-30
Brief Summary
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To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
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Detailed Description
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Conditions
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DCSZ11
Solid Tumors
HNSCC
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This single-center, open-label, single-arm trial employs a dose-escalation framework to assess DCSZ11's safety and biological activity when co-administered with guideline-directed standard therapy in advanced solid tumor patients. All participants will maintain fixed chemotherapy/immunotherapy regimens specific to their malignancy, with sole dose variation occurring for DCSZ11.
Three subjects in the lead-in cohort will initiate DCSZ11 at 600 mg triweekly. Sequential cohorts will escalate to 800 mg and 1200 mg administered Q3W. The 800 mg tier derives from prior clinical evidence (NCT05785754) evaluating DCSZ11-pembrolizumab combinations. Incorporation of the 600 mg cohort facilitates refined escalation protocols and enhanced resolution in safety/tolerability profiling.
Dose-limiting toxicities (DLTs) will undergo surveillance through a 21-day monitoring window. Escalation decisions will implement the Bayesian Optimal Interval (BOIN) methodology, with DLT classifications adhering to
Three subjects in the lead-in cohort will initiate DCSZ11 at 600 mg triweekly. Sequential cohorts will escalate to 800 mg and 1200 mg administered Q3W. The 800 mg tier derives from prior clinical evidence (NCT05785754) evaluating DCSZ11-pembrolizumab combinations. Incorporation of the 600 mg cohort facilitates refined escalation protocols and enhanced resolution in safety/tolerability profiling.
Dose-limiting toxicities (DLTs) will undergo surveillance through a 21-day monitoring window. Escalation decisions will implement the Bayesian Optimal Interval (BOIN) methodology, with DLT classifications adhering to
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Low Dose
DCSZ11 at Low Dose in combination with the available standard treatment.
Group Type
EXPERIMENTAL
Low Dose DCSZ11
Intervention Type
DRUG
Patients will receive DCSZ11 at 600 mg every three weeks (Q3W).
Standard Treatment
Intervention Type
DRUG
The available standard treatment for head and neck cancer patients.
Medium Dose
DCSZ11 at Medium Dose in combination with the available standard treatment.
Group Type
EXPERIMENTAL
Medium Dose DCSZ11
Intervention Type
DRUG
Patients will receive DCSZ11 at 800 mg Q3W.
Standard Treatment
Intervention Type
DRUG
The available standard treatment for head and neck cancer patients.
High Dose
DCSZ11 at High Dose in combination with the available standard treatment.
Group Type
EXPERIMENTAL
High Dose DCSZ11
Intervention Type
DRUG
Patients will receive DCSZ11 at 1200 mg Q3W.
Standard Treatment
Intervention Type
DRUG
The available standard treatment for head and neck cancer patients.
Interventions
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Low Dose DCSZ11
Patients will receive DCSZ11 at 600 mg every three weeks (Q3W).
Intervention Type
DRUG
Medium Dose DCSZ11
Patients will receive DCSZ11 at 800 mg Q3W.
Intervention Type
DRUG
High Dose DCSZ11
Patients will receive DCSZ11 at 1200 mg Q3W.
Intervention Type
DRUG
Standard Treatment
The available standard treatment for head and neck cancer patients.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Male or female patients aged ≥18 years.
2. Willing and able to provide written informed consent for the study.
3. Patients with histologically confirmed advanced or metastatic solid tumors. Note: Patients must have guideline-eligible standard chemotherapy and immunotherapy options available.Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) must have PD-L1 Combined Positive Score (CPS) ≥1.Lung cancer patients with known actionable driver gene mutations/genomic aberrations (e.g., EGFR sensitizing mutations, BRAF V600E mutation, ROS1 rearrangements, NTRK gene fusions, ALK rearrangements) are excluded.Prior adjuvant or neoadjuvant chemotherapy is permitted, provided ≥6 months have elapsed between the last dose of chemotherapy/immunotherapy and documented recurrent disease.Gastric cancer patients must be HER2-negative.
4. Patients must have at least one measurable lesion per RECIST 1.1 criteria. Lesions located in previously irradiated areas may be considered measurable if there is objective evidence of progression in those lesions prior to study enrollment.
5. Patients with previously treated central nervous system (CNS) metastases are eligible provided they meet all the following criteria:
1. Stability (i.e., no evidence of progression on magnetic resonance imaging \[MRI\]) for ≥4 weeks prior to the first dose of study drug, and
2. All neurological symptoms have returned to baseline, and
3. No requirement for steroid therapy for at least 14 days prior to the first dose of study intervention.
Patients with signs or symptoms suggestive of CNS metastases must undergo brain imaging within 2 weeks prior to the first dose of study drug to confirm the absence of detectable CNS disease.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function and bone marrow reserve per laboratory assessments within 10 days prior to first study drug administration:
1. Bone marrow function:
* Absolute neutrophil count (ANC) ≥1,500/µL
* Hemoglobin ≥9 g/dL (must be achieved without erythropoietin dependency AND without packed red blood cell \[pRBC\] transfusion within the preceding 2 weeks)
* Platelet count ≥100,000/µL
2. Hepatic function:
* Total serum bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin \>1.5 × ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN if liver metastases present)
3. Renal function:
* Estimated creatinine clearance ≥30 mL/min (per Cockcroft-Gault formula)
8. PD-L1 status must be available for all patients via approved immunohistochemistry assay.
9. Resolution of all prior treatment-related toxicities to Grade ≤1 or baseline, or determination as irreversible sequelae.
\*Note: Grade ≤2 neuropathy and/or hearing loss, alopecia of any grade, or autoimmune endocrinopathies on stable replacement therapy are permitted.\*
10. Female patients must agree to refrain from breastfeeding for 5 months after last study dose and satisfy one of:
1. Postmenopausal for ≥1 year prior to screening, or
2. Surgically sterile, or
3. Agreement to use one highly effective contraceptive method plus one additional barrier method from signing informed consent form (ICF) until 5 months after last study dose, or
4. Practice true abstinence\* when consistent with preferred lifestyle Periodic abstinence, withdrawal, spermicide-only, or lactational amenorrhea are unacceptable. Female/male condoms must not be used concomitantly.
11. Male patients, even surgically sterilized (i.e., post-vasectomy), must agree to either:
1. Use effective barrier contraception from ICF signing until 2 months after last DCSZ11 dose, or
2. Practice true abstinence\* when consistent with preferred lifestyle Exclusions as per Criterion 10.
12. Willingness and ability to comply with scheduled visits and procedures per protocol.
2. Willing and able to provide written informed consent for the study.
3. Patients with histologically confirmed advanced or metastatic solid tumors. Note: Patients must have guideline-eligible standard chemotherapy and immunotherapy options available.Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) must have PD-L1 Combined Positive Score (CPS) ≥1.Lung cancer patients with known actionable driver gene mutations/genomic aberrations (e.g., EGFR sensitizing mutations, BRAF V600E mutation, ROS1 rearrangements, NTRK gene fusions, ALK rearrangements) are excluded.Prior adjuvant or neoadjuvant chemotherapy is permitted, provided ≥6 months have elapsed between the last dose of chemotherapy/immunotherapy and documented recurrent disease.Gastric cancer patients must be HER2-negative.
4. Patients must have at least one measurable lesion per RECIST 1.1 criteria. Lesions located in previously irradiated areas may be considered measurable if there is objective evidence of progression in those lesions prior to study enrollment.
5. Patients with previously treated central nervous system (CNS) metastases are eligible provided they meet all the following criteria:
1. Stability (i.e., no evidence of progression on magnetic resonance imaging \[MRI\]) for ≥4 weeks prior to the first dose of study drug, and
2. All neurological symptoms have returned to baseline, and
3. No requirement for steroid therapy for at least 14 days prior to the first dose of study intervention.
Patients with signs or symptoms suggestive of CNS metastases must undergo brain imaging within 2 weeks prior to the first dose of study drug to confirm the absence of detectable CNS disease.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function and bone marrow reserve per laboratory assessments within 10 days prior to first study drug administration:
1. Bone marrow function:
* Absolute neutrophil count (ANC) ≥1,500/µL
* Hemoglobin ≥9 g/dL (must be achieved without erythropoietin dependency AND without packed red blood cell \[pRBC\] transfusion within the preceding 2 weeks)
* Platelet count ≥100,000/µL
2. Hepatic function:
* Total serum bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin \>1.5 × ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN if liver metastases present)
3. Renal function:
* Estimated creatinine clearance ≥30 mL/min (per Cockcroft-Gault formula)
8. PD-L1 status must be available for all patients via approved immunohistochemistry assay.
9. Resolution of all prior treatment-related toxicities to Grade ≤1 or baseline, or determination as irreversible sequelae.
\*Note: Grade ≤2 neuropathy and/or hearing loss, alopecia of any grade, or autoimmune endocrinopathies on stable replacement therapy are permitted.\*
10. Female patients must agree to refrain from breastfeeding for 5 months after last study dose and satisfy one of:
1. Postmenopausal for ≥1 year prior to screening, or
2. Surgically sterile, or
3. Agreement to use one highly effective contraceptive method plus one additional barrier method from signing informed consent form (ICF) until 5 months after last study dose, or
4. Practice true abstinence\* when consistent with preferred lifestyle Periodic abstinence, withdrawal, spermicide-only, or lactational amenorrhea are unacceptable. Female/male condoms must not be used concomitantly.
11. Male patients, even surgically sterilized (i.e., post-vasectomy), must agree to either:
1. Use effective barrier contraception from ICF signing until 2 months after last DCSZ11 dose, or
2. Practice true abstinence\* when consistent with preferred lifestyle Exclusions as per Criterion 10.
12. Willingness and ability to comply with scheduled visits and procedures per protocol.
Exclusion Criteria
1. Systemic anticancer therapy or investigational products within 6 months prior to first study dose.
\*Note: Low-dose corticosteroids (oral prednisolone ≤10 mg daily or equivalent) and therapy with bisphosphonates or RANK ligand (RANKL) inhibitors are permitted.\*
2. Extensive radiotherapy (RT) ≤6 months prior to treatment initiation (\*≤7 days for palliative local RT outside chest/brain\*) OR unresolved RT-related toxicity requiring corticosteroids.
3. Second primary malignancy within 3 years, except:
Adequately treated basal cell/locally confined squamous skin cancer Localized prostate cancer Carcinoma in situ of cervix/breast Resected colorectal adenomatous polyps Other malignancies not requiring active anticancer therapy.
4. Known active CNS metastases and/or carcinomatous meningitis.
5. Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.
All wounds must be fully healed without infection/dehiscence, with full recovery and no ongoing surgical complications.
6. Known hypersensitivity to any component of the study drug(s).
7. Prior immunotherapy discontinued due to:
Grade ≥3 immune-related adverse events (irAEs) (except endocrinopathies controlled with replacement) Grade 2 myocarditis OR recurrent Grade 2 pneumonitis.
8. Active autoimmune disease requiring systemic immunosuppression within 2 years. Exempt: Physiologic hormone replacement (thyroxine, insulin, corticosteroids for adrenal/pituitary insufficiency).
9. Immunodeficiency diagnosis OR chronic systemic steroids (\>10 mg prednisolone-equivalent/day) or other immunosuppressants within 7 days prior to first dose.
10. History of lung RT \>30 Gy within 6 months prior to treatment.
11. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) requiring steroids OR current pneumonitis/ILD.
12. History of allogeneic tissue/solid organ transplantation.
13. Live/live-attenuated vaccines within 4 weeks prior to treatment initiation. Inactivated vaccines permitted.
14. Active infection requiring systemic therapy.
15. Hepatitis B surface antigen (HBsAg)-positive with detectable HBV DNA.
16. Hepatitis C virus (HCV) infection with detectable HCV RNA at screening.
17. History within ≤6 months prior to first dose of:
NYHA Class III/IV congestive heart failure
Unstable angina
Myocardial infarction
Symptomatic ischemic heart disease
Uncontrolled hypertension despite optimal therapy
Persistent symptomatic arrhythmia \>Grade 2
Pericardial effusion/restrictive cardiomyopathy. Permitted: Chronic atrial fibrillation on stable anticoagulation.
18. Any condition compromising informed consent, confounding results, or limiting protocol compliance-including medical/psychiatric/social factors-that, per investigator judgment, contraindicates participation.
19. Pregnant or lactating females.
\*Note: Low-dose corticosteroids (oral prednisolone ≤10 mg daily or equivalent) and therapy with bisphosphonates or RANK ligand (RANKL) inhibitors are permitted.\*
2. Extensive radiotherapy (RT) ≤6 months prior to treatment initiation (\*≤7 days for palliative local RT outside chest/brain\*) OR unresolved RT-related toxicity requiring corticosteroids.
3. Second primary malignancy within 3 years, except:
Adequately treated basal cell/locally confined squamous skin cancer Localized prostate cancer Carcinoma in situ of cervix/breast Resected colorectal adenomatous polyps Other malignancies not requiring active anticancer therapy.
4. Known active CNS metastases and/or carcinomatous meningitis.
5. Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.
All wounds must be fully healed without infection/dehiscence, with full recovery and no ongoing surgical complications.
6. Known hypersensitivity to any component of the study drug(s).
7. Prior immunotherapy discontinued due to:
Grade ≥3 immune-related adverse events (irAEs) (except endocrinopathies controlled with replacement) Grade 2 myocarditis OR recurrent Grade 2 pneumonitis.
8. Active autoimmune disease requiring systemic immunosuppression within 2 years. Exempt: Physiologic hormone replacement (thyroxine, insulin, corticosteroids for adrenal/pituitary insufficiency).
9. Immunodeficiency diagnosis OR chronic systemic steroids (\>10 mg prednisolone-equivalent/day) or other immunosuppressants within 7 days prior to first dose.
10. History of lung RT \>30 Gy within 6 months prior to treatment.
11. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) requiring steroids OR current pneumonitis/ILD.
12. History of allogeneic tissue/solid organ transplantation.
13. Live/live-attenuated vaccines within 4 weeks prior to treatment initiation. Inactivated vaccines permitted.
14. Active infection requiring systemic therapy.
15. Hepatitis B surface antigen (HBsAg)-positive with detectable HBV DNA.
16. Hepatitis C virus (HCV) infection with detectable HCV RNA at screening.
17. History within ≤6 months prior to first dose of:
NYHA Class III/IV congestive heart failure
Unstable angina
Myocardial infarction
Symptomatic ischemic heart disease
Uncontrolled hypertension despite optimal therapy
Persistent symptomatic arrhythmia \>Grade 2
Pericardial effusion/restrictive cardiomyopathy. Permitted: Chronic atrial fibrillation on stable anticoagulation.
18. Any condition compromising informed consent, confounding results, or limiting protocol compliance-including medical/psychiatric/social factors-that, per investigator judgment, contraindicates participation.
19. Pregnant or lactating females.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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West China Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Xingchen Peng
PhD，professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Xingchen Peng, Professor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Central Contacts
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References
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BACKGROUND
Barbera S, Nardi F, Elia I, Realini G, Lugano R, Santucci A, Tosi GM, Dimberg A, Galvagni F, Orlandini M. The small GTPase Rab5c is a key regulator of trafficking of the CD93/Multimerin-2/beta1 integrin complex in endothelial cell adhesion and migration. Cell Commun Signal. 2019 May 28;17(1):55. doi: 10.1186/s12964-019-0375-x.
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BACKGROUND
Blackburn JWD, Lau DHC, Liu EY, Ellins J, Vrieze AM, Pawlak EN, Dikeakos JD, Heit B. Soluble CD93 is an apoptotic cell opsonin recognized by alphax beta2. Eur J Immunol. 2019 Apr;49(4):600-610. doi: 10.1002/eji.201847801. Epub 2019 Feb 7.
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BACKGROUND
Sun Y, Chen W, Torphy RJ, Yao S, Zhu G, Lin R, Lugano R, Miller EN, Fujiwara Y, Bian L, Zheng L, Anand S, Gao F, Zhang W, Ferrara SE, Goodspeed AE, Dimberg A, Wang XJ, Edil BH, Barnett CC, Schulick RD, Chen L, Zhu Y. Blockade of the CD93 pathway normalizes tumor vasculature to facilitate drug delivery and immunotherapy. Sci Transl Med. 2021 Jul 28;13(604):eabc8922. doi: 10.1126/scitranslmed.abc8922.
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BACKGROUND
Wu B, Fu L, Guo X, Hu H, Li Y, Shi Y, Zhang Y, Han S, Lv C, Tian Y. Multi-omics profiling and digital image analysis reveal the potential prognostic and immunotherapeutic properties of CD93 in stomach adenocarcinoma. Front Immunol. 2023 Jan 25;14:984816. doi: 10.3389/fimmu.2023.984816. eCollection 2023.
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BACKGROUND
Lugano R, Vemuri K, Yu D, Bergqvist M, Smits A, Essand M, Johansson S, Dejana E, Dimberg A. CD93 promotes beta1 integrin activation and fibronectin fibrillogenesis during tumor angiogenesis. J Clin Invest. 2018 Aug 1;128(8):3280-3297. doi: 10.1172/JCI97459. Epub 2018 Jun 25.
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BACKGROUND
Langenkamp E, Zhang L, Lugano R, Huang H, Elhassan TE, Georganaki M, Bazzar W, Loof J, Trendelenburg G, Essand M, Ponten F, Smits A, Dimberg A. Elevated expression of the C-type lectin CD93 in the glioblastoma vasculature regulates cytoskeletal rearrangements that enhance vessel function and reduce host survival. Cancer Res. 2015 Nov 1;75(21):4504-16. doi: 10.1158/0008-5472.CAN-14-3636. Epub 2015 Sep 11.
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Dieterich LC, Mellberg S, Langenkamp E, Zhang L, Zieba A, Salomaki H, Teichert M, Huang H, Edqvist PH, Kraus T, Augustin HG, Olofsson T, Larsson E, Soderberg O, Molema G, Ponten F, Georgii-Hemming P, Alafuzoff I, Dimberg A. Transcriptional profiling of human glioblastoma vessels indicates a key role of VEGF-A and TGFbeta2 in vascular abnormalization. J Pathol. 2012 Nov;228(3):378-90. doi: 10.1002/path.4072. Epub 2012 Aug 31.
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Reference Type
BACKGROUND
Other Identifiers
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2025（648）
Identifier Type: -
Identifier Source: org_study_id
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