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Solid TumorPhase 1NCT06443710

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

A Phase 1 study testing Technetium [99mTc]-H7ND injection in people with Solid Tumor, run by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Solid Tumor
What is being tested?
Technetium [99mTc]-H7ND injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
14 May 2024to 19 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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
  • Subjects with gastrointestinal malignancies who, in the judgment of the investigator, have received any medications and treatments prior to enrollment that may interfere with the trial data or that may have resulted in serious side effects that have not been fully cleared
  • Subjects with gastrointestinal malignancies who have an active or uncontrolled infection requiring systemic therapy within 14 days prior to initiation of study drug use
  • Subjects with malignant tumors of the gastrointestinal tract who have undergone major surgical procedures within 28 days prior to the start of investigational drug use-

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai

Other trials in China

About this study

Official title: A Phase I Clinical Study of the Pharmacokinetics and Safety of Technetium [99mTc]-H7ND Injection in Patients With Gastrointestinal Malignancies and Healthy Volunteers

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
Being tested
Technetium [99mTc]-H7ND injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technetium [99mTc]-H7ND injectionDrug

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

Study groups in NCT06443710
Study groupRoleWhat they receive
Patients with malignant tumors of the gastrointestinal tract or healthy subjectsExperimentalEach patient will receive 10 or 20 mCi ± 20% technetium [99mTc]-H7ND injection intravenously
Receives: Drug: Technetium [99mTc]-H7ND injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1-7 days from time of injection

Secondary outcomes (14)

  1. uptake value ratio

    Measure the count ratio of technetium [99mTc]-H7ND tumor area to blood pool, surrounding normal tissue, liver, and muscle in the integrated region of interest.

    Measured: 3 days after injection

  2. biodiversity distribution

    SPECT/CT whole-body scans were performed at different time points after drug injection to obtain radioactivity counts (%ID) in each major irradiated organ at each time phase to reflect the biodistribution of the drug in the body

    Measured: 3 days after injection

  3. internal radiation dose

    Plot the "time-activity count" curve for each major organ and calculate the area under the curve. Calculate the retention time of each major exposed organ and apply the software to estimate the absorbed dose of internal radiation for each major exposed organ.

    Measured: 3 days after injection

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

    Blood samples were collected at different time points after drug injection, and urine samples were collected at different time intervals for detection of technetium [99mTc] H7ND prototype and its radioactive metabolites using either a radioactive HPLC detector or a radioactive TLC detector.

    Measured: Predose and up to 72 hours postdose

  5. Pharmacokinetic parameters

    Cmax

    Measured: Predose and up to 72 hours postdose

  6. Pharmacokinetic parameters

    AUC(0-t)

    Measured: Predose and up to 72 hours postdose

  7. Pharmacokinetic parameters

    AUC(0-∞)

    Measured: Predose and up to 72 hours postdose

  8. Pharmacokinetic parameters

    Tmax

    Measured: Predose and up to 72 hours postdose

  9. Pharmacokinetic parameters

    T1/2

    Measured: Predose and up to 72 hours postdose

  10. Pharmacokinetic parameters

    AUC_%Extrap

    Measured: Predose and up to 72 hours postdose

  11. Pharmacokinetic parameters

    CL

    Measured: Predose and up to 72 hours postdose

  12. Pharmacokinetic parameters

    Vd

    Measured: Predose and up to 72 hours postdose

  13. Pharmacokinetic parameters

    MRT

    Measured: Predose and up to 72 hours postdose

  14. Pharmacokinetic parameters

    λz

    Measured: Predose and up to 72 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start14 May 2024
  3. Primary completion19 Nov 2024
  4. Study completion19 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443710
Sponsor's protocol ID
2023LP02630
Status last verified
Sep 2024
First submitted
23 May 2024
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Technetium [99mTc]-H7ND injection in people with Solid Tumor, run by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Security Indicators (time frame: 1-7 days from time of injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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