A Study of DXC014 in Patients With Advanced Solid Tumors.

NCT07177937 | Recruiting Phase 1

• 1 other identifier: DXC014-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors.

Conditions

Small Cell Lung Cancer; Melanoma; Prostate Cancer; Other Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

  Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.

  28 days

• Number of participants with adverse events (AEs)

  The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.

  After first infusion of study drug, Through study completion an average of 1 year

Secondary Outcomes (2)

• Maximum observed serum or plasma concentration (Cmax)

  Through study completion an average of 1 year

• Maximum serum drug time（Tmax）

  Through study completion an average of 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Dose Escalation DXC014, Cohort Expansion DXC014

Drug: DXC014

Interventions

DXC014 DRUG

Dose Escalation DXC014, Cohort Expansion DXC014

Experimental

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements.
• Male or female.
• For other solid tumor patients: Age ≥18 years and ≤75 years；For prostate cancer patients: Age ≥18 years.
• Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• \. Prostate cancer,other solid tumors. 7. Prostate Cancer (Two Parallel Cohorts): Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: Presence of ≥1 metastatic lesion(s) confirmed by baseline CT, MRI, or bone scan.Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.
• Other Solid Tumors: At least one measurable lesion as defined by RECIST v1.1. 8. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 as defined by NCI-CTCAE v5.0 (except alopecia). Grade 2 toxicities per NCI-CTCAE v5.0 may be permitted if judged by the investigator to pose no safety risk.
• \. Adequate organ function as defined by the following laboratory values: Hematological:(1) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (No use of G-CSF or granulocyte-/white blood cell-boosting drugs within 7 days prior to the screening lab test). (2) Platelet count ≥ 100 × 10⁹/L (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test). (3) Hemoglobin (HGB) ≥ 90 g/L (No red blood cell (RBC) or whole blood transfusion or hemoglobin-boosting drugs within 7 days prior to the screening lab test).Hepatic: (1) Total Bilirubin (TBIL) ≤ 1.5 × ULN (Upper Limit of Normal); except for participants with congenital bilirubinemia, e.g., Gilbert's syndrome (Direct bilirubin ≤ 1.5 × ULN). (2) AST and ALT ≤ 3.0 × ULN. (3) AST and ALT ≤ 5.0 × ULN in the presence of liver metastases. Renal: Creatinine Clearance (Ccr) ≥ 60 mL/min OR Serum Creatinine (Cr) ≤ 1.5 × ULN. For participants with urinalysis showing urine protein ≥ 2+ at screening, a 24-hour urine protein quantification should be performed; participants with a 24-hour urine protein ≤ 1 g may be enrolled. Coagulation: (1) International Normalized Ratio (INR) ≤ 1.5. (2) Activated Partial Thromboplastin Time (APTT) or Prothrombin Time (PT) ≤ 1.5 × ULN. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
• \. Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.

You may not qualify if:

• Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose \>10 mg/day prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).
• Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.
• History of solid organ transplantation.
• Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.
• Evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula \[QTcF\]). b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd-degree (Mobitz Type II) or 3rd-degree atrioventricular block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to screening. d. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. e. Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Uncontrolled diabetes mellitus.
• Current interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, severely impaired pulmonary function, or other conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• History of or current other malignancies within the past 5 years. Participants may be enrolled in the following two scenarios: other malignancies treated with single surgery alone, achieving continuous 5-year disease-free survival (DFS); adequately treated carcinoma in situ with no evidence of recurrence, such as cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\].
• Presence of severe unhealed wounds, ulcers, or fractures; major surgery within 28 days prior to the first dose or anticipated major surgery during the clinical study period.
• History of allergy to any component or excipient of DXC014 .
• Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or above the upper limit of normal \[ULN\] of the testing unit); active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).
• Known positive HIV serology; active syphilis (participants with only a positive syphilis antibody test may be enrolled); suspected active tuberculosis (chest imaging within 3 months prior to the first dose suggests active tuberculosis infection).
• Active bleeding within 30 days prior to screening, or judged by the investigator to be at risk of major gastrointestinal bleeding, hemoptysis, etc.; or hereditary bleeding tendency or coagulation dysfunction; or hemorrhagic symptoms requiring other medical intervention.
• History of severe arterial/venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism.
• Female participants who are pregnant (positive serum pregnancy test) or breastfeeding.

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Melanoma; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Pengyu Shi

CONTACT

86-0571-56050590; Shipengyu@dacbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): October 20, 2030
• Study Completion (Estimated): October 20, 2030
• Last Updated: April 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)