DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors

NCT07035249 | Recruiting Phase 1 DMC

• 1 other identifier: 2025（648）
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ratio of participants assessed with complete response (CR) or partial response(PR) as a best overall response.

  2 years

Secondary Outcomes (7)

• Disease Control Rate (DCR)

  2 years

• DRR (Durable Response Rate)

  2 years

• DOR (Duration of Response)

  2 years

• TTR (Response Time）

  2 years

• PFS (progression-free survival)

  2 years

Study Arms (3)

Low Dose

EXPERIMENTAL

DCSZ11 at Low Dose in combination with the available standard treatment.

Drug: Low Dose DCSZ11; Drug: Standard Treatment

Medium Dose

EXPERIMENTAL

DCSZ11 at Medium Dose in combination with the available standard treatment.

Drug: Medium Dose DCSZ11; Drug: Standard Treatment

High Dose

EXPERIMENTAL

DCSZ11 at High Dose in combination with the available standard treatment.

Drug: High Dose DCSZ11; Drug: Standard Treatment

Interventions

Low Dose DCSZ11 DRUG

Patients will receive DCSZ11 at 600 mg every three weeks (Q3W).

Low Dose

Medium Dose DCSZ11 DRUG

Patients will receive DCSZ11 at 800 mg Q3W.

Medium Dose

High Dose DCSZ11 DRUG

Patients will receive DCSZ11 at 1200 mg Q3W.

High Dose

Standard Treatment DRUG

The available standard treatment for head and neck cancer patients.

High Dose; Low Dose; Medium Dose

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Sichuan University West China Hospital, Chengdu, Sichuan

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 15331400 RESULT

• 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.

  PMID: 31138217 RESULT

• 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.

  PMID: 30656676 RESULT

• 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.

  PMID: 34321321 RESULT

• 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.

  PMID: 36761750 RESULT

• 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.

  PMID: 29763414 RESULT

• 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.

  PMID: 26363010 RESULT

• 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.

  PMID: 22786655 RESULT

• Khan 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.

  PMID: 28671670 RESULT

• Jain 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.

  PMID: 25517747 RESULT

• Reichart 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.

  PMID: 15975518 RESULT

• Boucher 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.

  PMID: 34188163 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Xingchen Peng, Professor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng, Professor

CONTACT

18980606753; pxx2014@163.com

Ziyu Xu

CONTACT

+86 19961578835; 19961578835@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD，professor

Model Details: 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

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 25, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)