metastatic CRC
Conditions
Interventions
68Ga-R12033 Group:[68Ga]-R12033 PET/CT Imaging
177Lu-R12033 Group:[177Lu]-R12033 SPECT/CT imaging
68Ga-R14014 Group:[68Ga]-R14014 PET/CT Imaging
177Lu-R14014 Group:[177Lu]-R14014 SPECT/CT imaging
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Have signed the informed consent form prior to any study procedures; 2.Male or female Participants aged >=18 years; 3.Histologically or cytologically confirmed advanced cancer as follows: Cohort 1: metastatic CRC; Cohort 2: unresectable, locally advanced or metastatic PDAC; Cohort 3: unresectable, locally advanced or metastatic HNSCC; 4.At least one tumor lesion equals or exceeds 2 cm in largest diameter within 60days prior to dosing, confirmed by the standard of care imaging (enhanced CT or MRI); 5.ECOG score of 0 to 2; 6.Estimated life expectancy >3 months; 7.Adequate organ function as evidenced by: Absolute neutrophil count (ANC) >=1.5× 10 9/L (Part B only), Platelets count >=100 × 10 9/L (Part B only), Hemoglobin>=85 g/L, Total bilirubin (TBIL) <=1.5 × upper limit of normal range (ULN),alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 ×ULN (or <=5 × ULN if liver metastases are present), Serum creatinine (SCr) <=1.5×ULN. 8.For Participants with childbearing potential: Partner and/or Participant must use a method of birth control with adequate barrier protection, deemed acceptable by the Investigator during the study (Part A1, A2, B1 and Part B2), and for at least 90 days after administration of 177 Lu-R12033 or 177Lu-R14014 (Part B1 and B2);
Exclusion criteria
Exclusion criteria: 1. Have received other Investigational Products targeting the same target (except IPs in the current study) for imaging or treatment prior to administration of IP. 2. Taking part in any other clinical trials or receiving other Investigational Products (observational trials can be allowed). 3. Administration of any radiopharmaceutical (except 177Lu-IPs in the current study) within 10 half-lives of that radionuclide before IP administration. 4. Radiotherapy <=14 days prior to dosing with IP. 5. Had undergone surgery within 21 days before IP administration or have plan to undergo surgery during the study. 6. With symptomatic brain metastases or receiving high-dose hormones therapy to maintain the integrity of the central nervous system function. 7. The presence of other active malignancies that may interfere with disease assessment; Study Participants with a history of malignant tumor previously who had fully recovered at least 3 years prior to receiving IP and have no evidence of recurrence can be enrolled. 8. Concomitant uncontrolled medical conditions, including but not limited to severe infections requiring hospitalization or continuous antibiotic treatment. 9. Serious cardiovascular system diseases, such as chronic heart failure NYHA heart function class III-IV, uncontrolled high blood pressure, malignant arrhythmia, unstable angina, coronary artery bypass surgery (CABG) history or myocardial infarction (MI) within 6 months prior to study screening. 10. Study Participants are unwilling or unable to undergo study related imaging scans during the study due to various reasons. 11. Any uncontrolled significant medical, psychiatric or surgical condition or laboratory finding that would pose a risk to patient safety or interfere with study participation by the investigator’s discretion. 12. Known or expected hypersensitivity to the assigned IP or any of its components. 13. Pregnant or lactating women. 14. Had any other serious medical condition that was deemed to be inappropriate for participation of study by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Biodistribution; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosimetry; | — |
Countries
China
Contacts
Public ContactGao Rui
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed