DCSZ11Phase 1/2NCT07035249
DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing Low Dose DCSZ11, Medium Dose DCSZ11 and High Dose DCSZ11 in people with DCSZ11 and Solid Tumors, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DCSZ11, Solid Tumors, HNSCC
- What is being tested?
- Low Dose DCSZ11, Medium Dose DCSZ11 and High Dose DCSZ11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 30 Jul 2027
- Phase
- Phase 1/2
- 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
- Male or female patients aged ≥18 years.
- Willing and able to provide written informed consent for the study.
- 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.
- 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.
- Patients with previously treated central nervous system (CNS) metastases are eligible provided they meet all the following criteria:
- Stability (i.e., no evidence of progression on magnetic resonance imaging [MRI]) for ≥4 weeks prior to the first dose of study drug, and
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- All neurological symptoms have returned to baseline, and
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function and bone marrow reserve per laboratory assessments within 10 days prior to first study drug administration:
- 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
- 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)
- Renal function:
- Estimated creatinine clearance ≥30 mL/min (per Cockcroft-Gault formula)
- PD-L1 status must be available for all patients via approved immunohistochemistry assay.
- 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.
- Female patients must agree to refrain from breastfeeding for 5 months after last study dose and satisfy one of:
- Postmenopausal for ≥1 year prior to screening, or
- Surgically sterile, or
- 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
- 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.
- Male patients, even surgically sterilized (i.e., post-vasectomy), must agree to either:
- Use effective barrier contraception from ICF signing until 2 months after last DCSZ11 dose, or
- Practice true abstinence* when consistent with preferred lifestyle Exclusions as per Criterion 10.
- Willingness and ability to comply with scheduled visits and procedures per protocol.
Who cannot join
- 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.
- 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.
- 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.
- Known active CNS metastases and/or carcinomatous meningitis.
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- 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.
- Known hypersensitivity to any component of the study drug(s).
- 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.
- Active autoimmune disease requiring systemic immunosuppression within 2 years. Exempt: Physiologic hormone replacement (thyroxine, insulin, corticosteroids for adrenal/pituitary insufficiency).
- Immunodeficiency diagnosis OR chronic systemic steroids (>10 mg prednisolone-equivalent/day) or other immunosuppressants within 7 days prior to first dose.
- History of lung RT >30 Gy within 6 months prior to treatment.
- History of (non-infectious) pneumonitis/interstitial lung disease (ILD) requiring steroids OR current pneumonitis/ILD.
- History of allogeneic tissue/solid organ transplantation.
- Live/live-attenuated vaccines within 4 weeks prior to treatment initiation. Inactivated vaccines permitted.
- Active infection requiring systemic therapy.
- Hepatitis B surface antigen (HBsAg)-positive with detectable HBV DNA.
- Hepatitis C virus (HCV) infection with detectable HCV RNA at screening.
- 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.
- Any condition compromising informed consent, confounding results, or limiting protocol compliance-including medical/psychiatric/social factors-that, per investigator judgment, contraindicates participation.
- Pregnant or lactating females.
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
Sichuan University West China Hospital, Chengdu, Sichuan
Chengdu, Sichuan, 610041
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
Official title: A Prospective, Single-Arm Clinical Trial Evaluating DCSZ11 Combined With Standard-of-Care Therapy in Patients With Advanced or Metastatic Solid Tumors
To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
- Conditions
- DCSZ11, Solid Tumors, HNSCC
- Being tested
- Low Dose DCSZ11, Medium Dose DCSZ11, High Dose DCSZ11, Standard Treatment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose DCSZ11Drug
Patients will receive DCSZ11 at 600 mg every three weeks (Q3W).
Medium Dose DCSZ11Drug
Patients will receive DCSZ11 at 800 mg Q3W.
High Dose DCSZ11Drug
Patients will receive DCSZ11 at 1200 mg Q3W.
The available standard treatment for head and neck cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | DCSZ11 at Low Dose in combination with the available standard treatment. Receives: Drug: Low Dose DCSZ11; Drug: Standard Treatment |
| Medium Dose | Experimental | DCSZ11 at Medium Dose in combination with the available standard treatment. Receives: Drug: Medium Dose DCSZ11; Drug: Standard Treatment |
| High Dose | Experimental | DCSZ11 at High Dose in combination with the available standard treatment. Receives: Drug: High Dose DCSZ11; Drug: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The ratio of participants assessed with complete response (CR) or partial response(PR) as a best overall response.
Measured: 2 years
Secondary outcomes (7)
Disease Control Rate (DCR)
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overalresponse.
Measured: 2 years
DRR (Durable Response Rate)
DRR is defined as the proportion of objective response (CR and PR as determined by the investigator) lasting at least 6 months at any time within 12 months of initiation of treatment.
Measured: 2 years
DOR (Duration of Response)
DOR is defined as the time from the date when the PR is first recorded or better to the date when the disease progression is first recorded (for the responder, i.e., PR or better). Responders who did not record disease progress will be censored on the date that the last assessment was SD or better.
Measured: 2 years
TTR (Response Time）
TTR is defined as the time from the date of the first administration to the date of the first record of the objective tumor response (CR and PR determined by the investigator).
Measured: 2 years
PFS (progression-free survival)
PFS is defined as the duration until disease progression or death in participants fromthe first dose of immunization.
Measured: 2 years
OS (Overall Survival)
0S is defined as the duration until death in participants from the first dose ofimmunization.
Measured: 2 years
TTP (Time to Progression)
TTP is defined as the time from the date of first dose to the date of first documented disease progression, as defined by standard disease criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start16 Dec 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DCSZ11Studies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035249
- Sponsor's protocol ID
- 2025（648）
- Status last verified
- Mar 2026
- First submitted
- 15 Jun 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilgus TA, Bergdall VK, Tober KL, Hill KJ, Mitra S, Flavahan NA, Oberyszyn TM. The impact of cyclooxygenase-2 mediated inflammation on scarless fetal wound healing. Am J Pathol. 2004 Sep;165(3):753-61. doi: 10.1016/S0002-9440(10)63338-X.
PubMed 15331400Barbera 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.
PubMed 31138217Blackburn 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.
PubMed 30656676Sun 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.
PubMed 34321321Wu 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.
PubMed 36761750Lugano 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.
PubMed 29763414Langenkamp 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.
PubMed 26363010Dieterich 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.
PubMed 22786655Khan KA, Naylor AJ, Khan A, Noy PJ, Mambretti M, Lodhia P, Athwal J, Korzystka A, Buckley CD, Willcox BE, Mohammed F, Bicknell R. Multimerin-2 is a ligand for group 14 family C-type lectins CLEC14A, CD93 and CD248 spanning the endothelial pericyte interface. Oncogene. 2017 Nov 2;36(44):6097-6108. doi: 10.1038/onc.2017.214. Epub 2017 Jul 3.
PubMed 28671670Jain RK. Antiangiogenesis strategies revisited: from starving tumors to alleviating hypoxia. Cancer Cell. 2014 Nov 10;26(5):605-22. doi: 10.1016/j.ccell.2014.10.006. Epub 2014 Nov 10.
PubMed 25517747Reichart PA, Philipsen HP. Oral erythroplakia--a review. Oral Oncol. 2005 Jul;41(6):551-61. doi: 10.1016/j.oraloncology.2004.12.003. Epub 2005 Apr 9.
PubMed 15975518Boucher Y, Kumar AS, Posada JM, Gjini E, Pfaff K, Lipschitz M, Lako A, Duda DG, Rodig SJ, Hodi FS, Jain RK. Bevacizumab improves tumor infiltration of mature dendritic cells and effector T-cells in triple-negative breast cancer patients. NPJ Precis Oncol. 2021 Jun 29;5(1):62. doi: 10.1038/s41698-021-00197-w.
PubMed 34188163
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Clinical Trial Evaluating DCSZ11 Combined With Standard-of-Care Therapy in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07035249
- Acronym / sponsor ID
- 2025（648）
- Conditions
- DCSZ11, Solid Tumors, HNSCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Low Dose DCSZ11, Drug: Standard TreatmentDCSZ11 at Low Dose in combination with the available standard treatment. |
| Medium Dose | Experimental | Drug: Medium Dose DCSZ11, Drug: Standard TreatmentDCSZ11 at Medium Dose in combination with the available standard treatment. |
| High Dose | Experimental | Drug: High Dose DCSZ11, Drug: Standard TreatmentDCSZ11 at High Dose in combination with the available standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Male or female patients aged ≥18 years.
- Willing and able to provide written informed consent for the study.
- 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.
- 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.
- Patients with previously treated central nervous system (CNS) metastases are eligible provided they meet all the following criteria:
Key exclusion criteria (30 listed)
- 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.
- 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.
- 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.
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 |
|---|---|---|
| Low Dose DCSZ11Patients will receive DCSZ11 at 600 mg every three weeks (Q3W). | Drug | Low Dose |
| Medium Dose DCSZ11Patients will receive DCSZ11 at 800 mg Q3W. | Drug | Medium Dose |
| High Dose DCSZ11Patients will receive DCSZ11 at 1200 mg Q3W. | Drug | High Dose |
| Standard TreatmentThe available standard treatment for head and neck cancer patients. | Drug | High Dose, Low Dose, Medium Dose |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
The ratio of participants assessed with complete response (CR) or partial response(PR) as a best overall response.
7 secondary outcomes
Disease Control Rate (DCR)
Time frame: 2 years
DRR (Durable Response Rate)
Time frame: 2 years
DOR (Duration of Response)
Time frame: 2 years
TTR (Response Time）
Time frame: 2 years
PFS (progression-free survival)
Time frame: 2 years
OS (Overall Survival)
Time frame: 2 years
TTP (Time to Progression)
Time frame: 2 years
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 11 Mar 2026.
- Results publication: PubMed 15331400Wilgus TA, Bergdall VK, Tober KL, Hill KJ, Mitra S, Flavahan NA, Oberyszyn TM. The impact of cyclooxygenase-2 mediated inflammation on scarless fetal wound healing. Am J Pathol. 2004 Sep;165(3):753-61. doi: 10.1016/S0002-9440(10)63338-X.
- Results publication: PubMed 31138217Barbera 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.
- Results publication: PubMed 30656676Blackburn 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.
- Results publication: PubMed 34321321Sun 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.
- Results publication: PubMed 36761750Wu 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.
- Results publication: PubMed 29763414Lugano 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.
- Results publication: PubMed 26363010Langenkamp 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.
- Results publication: PubMed 22786655Dieterich 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.
- Results publication: PubMed 28671670Khan KA, Naylor AJ, Khan A, Noy PJ, Mambretti M, Lodhia P, Athwal J, Korzystka A, Buckley CD, Willcox BE, Mohammed F, Bicknell R. Multimerin-2 is a ligand for group 14 family C-type lectins CLEC14A, CD93 and CD248 spanning the endothelial pericyte interface. Oncogene. 2017 Nov 2;36(44):6097-6108. doi: 10.1038/onc.2017.214. Epub 2017 Jul 3.
- Results publication: PubMed 25517747Jain RK. Antiangiogenesis strategies revisited: from starving tumors to alleviating hypoxia. Cancer Cell. 2014 Nov 10;26(5):605-22. doi: 10.1016/j.ccell.2014.10.006. Epub 2014 Nov 10.
- Results publication: PubMed 15975518Reichart PA, Philipsen HP. Oral erythroplakia--a review. Oral Oncol. 2005 Jul;41(6):551-61. doi: 10.1016/j.oraloncology.2004.12.003. Epub 2005 Apr 9.
- Results publication: PubMed 34188163Boucher Y, Kumar AS, Posada JM, Gjini E, Pfaff K, Lipschitz M, Lako A, Duda DG, Rodig SJ, Hodi FS, Jain RK. Bevacizumab improves tumor infiltration of mature dendritic cells and effector T-cells in triple-negative breast cancer patients. NPJ Precis Oncol. 2021 Jun 29;5(1):62. doi: 10.1038/s41698-021-00197-w.
- Individual participant dataSharing planned: No
Related trials for DCSZ11
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
RecruitingPhase 1
DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumors
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.
Xingchen Peng, Professor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Dose DCSZ11, Medium Dose DCSZ11 and High Dose DCSZ11 in people with DCSZ11 and Solid Tumors, run by West China Hospital 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 32 inclusion and 30 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 11 Mar 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 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?
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 Xingchen Peng, Professor (18980606753, pxx2014@163.com), 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: 2 years). 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 NCT07035249, which also lists 12 linked publications.
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 11 Mar 2026.