Inclusion Criteria:
1. Voluntarily sign the informed consent form and comply with the protocol
requirements.
2. Male or female.
3. For other solid tumor patients: Age ≥18 years and ≤75 years；For prostate cancer
patients: Age ≥18 years.
4 .Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance
status score of 0 or 1.
6. 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.
9. 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%.
10. 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.
Exclusion Criteria:
1. 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).
2. 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.
3. History of solid organ transplantation.
4. 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.
5. 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).
6. Uncontrolled diabetes mellitus.
7. 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.
8. 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)].
9. 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.
10. History of allergy to any component or excipient of DXC014 .
11. 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).
12. 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).
13. 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.
14. 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.
15. Female participants who are pregnant (positive serum pregnancy test) or
breastfeeding.
16. Active infection requiring systemic medication (CTCAE ≥ Grade 2) within 2 weeks
prior to the first dose of study treatment; uncontrolled pleural effusion, ascites,
or pericardial effusion requiring repeated drainage.
17. Administration of a live attenuated vaccine within 28 days prior to the first dose
or planned vaccination during the study period.
18. Any other condition that, in the judgment of the investigator or sponsor, may affect
the participant's participation in this study.
