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A Phase 0 clinical trial evaluating the safety and tolerability, radiation dosimetry, biodistribution, and imaging characteristics of 64Cu-TRD2206 injection in patients with malignant solid tumors

A Phase 0 clinical trial evaluating the safety and tolerability, radiation dosimetry, biodistribution, and imaging characteristics of 64Cu-TRD2206 injection in patients with malignant solid tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091450
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant solid tumors

Interventions

Experimental group:64Cu-TRD2206 PET/CT

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. A signed informed consent must be obtained before participating in the study; 2.18 years old <= age <=79 years old; 3. Malignant solid tumors confirmed histologically or cytologically (urothelial carcinoma, esophageal carcinoma, cervical cancer, etc.); 4. Imaging examination confirmed or suspected the presence of at least 2 metastases (except biopsy lesions) 28 days before administration, and those with visceral metastases were prefered to be included; 5.ECOG score is 0-2 points; 6.Adequate organ function: bone marrow reserve: neutrophil count (ANC) = 1.5×10^9/L, platelet count =90×10^9/L, hemoglobin =90 g/L; Liver: total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0×ULN; Kidney: Serum creatinine (SCr) =1.5×ULN.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to undergo PET examination due to reasons such as weight, claustrophobia, radiation phobia, or inability to lie still for a long time during the examination, or researchers judge that patients are unable to cooperate with the imaging examination and operation; 2.4 Received previous chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy (except anti-cancer Chinese medicine treatment) within weeks; 3. Patients with central nervous system (CNS) metastases who have symptoms or are receiving glucocorticoid therapy; 4. Patients with a history of other malignant tumors (except those who have received radical treatment, who have finished treatment for more than 3 years before enrollment, and who have no evidence of recurrence/metastasis); 5. Combination of serious or poorly controlled medical conditions, including but not limited to difficult-to-control infections, hypertension, acute coronary syndromes, or other conditions that the investigator believes may affect the study; 6. Allergic to the investigational drug and its components; 7. The woman's blood pregnancy test is positive within 7 days before the study drug injection; 8. Patients who do not agree to use effective contraception or restrictive practices during the study period and 4 weeks after dosing; 9. Lactating women; 10.There are other conditions that the investigator deems unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Biological distribution characteristics;Safety and tolerability;Radiation dosimetry characteristics;Imaging characteristics;

Countries

China

Contacts

Public ContactWen Dan

Affiliated Hospital of North Sichuan Medical College

876008292@qq.com+86 152 8174 1725

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026