Technetium [99mTc]-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers

NCT06443710 | Completed Phase 1

• 1 other identifier: 2023LP02630
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is: to evaluate the safety of technetium \[99mTc\]-H7ND injection in patients with gastrointestinal malignancies and in healthy subjects. The secondary objectives of this study are: (1) to examine the pharmacokinetics of technetium \[99mTc\]-H7ND Injection in healthy subjects. (2) Detect the metabolic stability of technetium \[99mTc\]-H7ND injection in healthy humans. (3) Detect the biodistribution and estimate the absorbed dose of radiation from internal irradiation of technetium \[99mTc\]-H7ND injection in patients with malignant tumors of the gastrointestinal tract and in healthy humans.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Security Indicators

  Evaluation of adverse events and serious adverse events according to the Common Terminology Criteria for the Evaluation of Adverse Events (NCI-CTCAE) version 5.0

  1-7 days from time of injection

Secondary Outcomes (14)

• uptake value ratio

  3 days after injection

• biodiversity distribution

  3 days after injection

• internal radiation dose

  3 days after injection

• Concentration of technetium [99mTc] H7ND prototype and its radioactive metabolites

  Predose and up to 72 hours postdose

• Pharmacokinetic parameters

  Predose and up to 72 hours postdose

Study Arms (1)

Patients with malignant tumors of the gastrointestinal tract or healthy subjects

EXPERIMENTAL

Each patient will receive 10 or 20 mCi ± 20% technetium \[99mTc\]-H7ND injection intravenously

Drug: Technetium [99mTc]-H7ND injection

Interventions

Technetium [99mTc]-H7ND injection DRUG

Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor

Patients with malignant tumors of the gastrointestinal tract or healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects should be adult males or females aged 18-75 years (including borderline values, based on the time of signing the informed consent form) at screening, and not less than 1/3 of the total number of cases of each gender
• All subjects who are males or females of childbearing potential must be using effective contraception during the study period (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or vasectomy)
• All subjects are fully aware of the purpose, nature, methods, and possible adverse effects of the trial, voluntarily participate and sign a written informed consent form, and are able to follow the protocol requirements to complete the study
• Healthy subjects with a body mass index within the range of 18.0 to 26.0 kg/m2 (including the borderline value), male subjects weighing ≥ 50 kg, female subjects weighing ≥ 45 kg
• Healthy subjects are in good health or do not have a history of major diseases
• Vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) results of healthy subjects during the screening period are not abnormal or the abnormalities are not clinically significant.
• Gastrointestinal malignant tumor subjects with histologically/cytologically confirmed diagnosis of gastrointestinal malignant tumors (including stomach, small intestine and colorectum)
• Subjects with gastrointestinal malignant tumors with an ECOG score of 0 - 1
• Subjects with gastrointestinal malignant tumors Blood routine: WBC ≥ 3 × 109 / L, ANC ≥ 1.5 × 109 / L, Hb ≥ 90 g / L, PLT ≥ 75 × 109 / L; Liver function: TBIL ≤ 1.5 × ULN, ALT, AST ≤ 3 × ULN (≤ 5 × ULN for liver metastases); Kidney function: Cr ≤ 1.5 × ULN; Coagulation function: Prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN, international normalized ratio (INR) ≤1.5×ULN; Electrolytes: corrected magnesium ≥LLN, allowed to correct electrolytes during the screening period Cardiac function: left ventricular ejection fraction ≥ 50%
• Subjects who have recovered to Grade 1 (CTCAE Version 5.0) from damage caused by other therapies, except: alopecia, hyperpigmentation; and if nutritionally stable, the presence of irrecoverable long-term toxicity as determined by the Investigator is permitted.
• Subjects with gastrointestinal malignancies expected to survive ≥ 12 weeks

You may not qualify if:

• Pregnant (positive screening pregnancy test) or breastfeeding female
• History of alcohol or drug abuse/dependence
• Known allergy to radioactive rays, or history of other severe allergies
• Human immunodeficiency virus (HIV) positive or not definitively negative, hepatitis C virus (HCV) or syphilis spirochete antibody test positive, hepatitis B virus (HBV) surface antigen positive and quantitative HBV DNA test ≥ 1.0×103 IU/mL
• Significant occupational exposure to ionizing radiation in the past 10 years
• Unable to repeat venipuncture
• Participation in a clinical study of another drug within 30 days prior to screening and use of another test drug
• Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate
• Subjects with gastrointestinal malignancies requiring treatment of symptomatic brain metastases
• Subjects with gastrointestinal malignancies who have a history of other malignancies, except for malignant lesions that have been treated with therapeutic measures 5 or more years prior to the initiation of investigational drug use and are not known to be active, and who, in the judgment of the Investigator, are at low risk of recurrence. Adequately treated non-melanoma skin cancer or malignant freckle-like nevus without evidence of disease progression. Adequately treated in situ cervical cancer with no evidence of progression. Intraepithelial tumor of the prostate gland without evidence of prostate adenocarcinoma
• Subjects with gastrointestinal malignancies who have developed clinically significant cardiovascular disease (including, but not limited to, myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure, and uncontrolled severe arrhythmia) within 6 months prior to initiation of study drug use
• Subjects with gastrointestinal malignancies who have hypertension that is uncontrollable with a single agent
• Subjects with malignant tumors of the gastrointestinal tract who have a history of hepatic disease or other conditions that interfere with the absorption, distribution, excretion, or metabolism of the drug, as determined by the investigator
• Subjects with gastrointestinal malignancies have a history of coagulopathy or coagulation disorders.
• History of arterial or venous embolism in subjects with gastrointestinal malignancies

Sponsors & Collaborators

• Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Technetium

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Study Design

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

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 5, 2024
• Study Start: May 14, 2024
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: July 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)