AzTrials
AzTrials

Soft Tissue SarcomaPhase 1NCT07920822

Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing 177Lu-HX02 injection in people with Soft Tissue Sarcoma and Non-small Cell Lung Cancer, run by Hexin (Suzhou) Pharmaceutical Technology Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single-center, open-label, phase I dose-escalation clinical trial, aiming to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, as well as the preliminary efficacy of 177Lu-HX02 injection in patients with advanced malignant solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
177Lu-HX02 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
29 Jan 2026to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a thorough understanding of this study and have voluntarily signed the informed consent form;
  • Age 18 to 75 years old, gender not restricted;
  • ECOG score 0 to 1, able to tolerate PET/CT and SPECT/CT examinations;
  • Expected survival period ≥ 6 months;
  • Histologically or cytologically diagnosed as advanced malignant solid tumor;
  • Previous standard treatment failed;
Show all 15Show fewer
  • 68Ga-HX01 PET/CT imaging positive. Defined as at least one lesion in the 68Ga-HX01 PET/CT imaging having SUVmax ≥ 3.0 or tumor-to-liver ratio (SUVmax/SUVmean) (T/L ratio) > 1;
  • According to RECIST 1.1 standard, at least one measurable tumor lesion. For lesions that have received previous radiotherapy, the lesion can be included in the measurable lesion only when there is clear disease progression after radiotherapy;
  • Toxicity of previous anti-tumor treatment (such as previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has recovered to ≤ grade 1 level (except for hair loss);
  • The functional level of organs must meet the following requirements:
  • Bone marrow Neutrophil count ≥ 1.5×109/L and white blood cell count ≥ 2.5×109/L; Platelets ≥ 100×109/L; Hemoglobin ≥ 90 g/L;
  • Liver function Total bilirubin ≤ 1.5×ULN (for liver metastasis subjects, total bilirubin ≤ 2×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3×ULN (for liver metastasis subjects, ALT and AST < 5×ULN); Albumin > 30 g/L;
  • Renal function Serum creatinine ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL/min;
  • Coagulation function International normalized ratio (INR) ≤ 2.0, activated partial thromboplastin time (APTT) ≤ 1.5×ULN. Exception: Subjects receiving warfarin anticoagulation therapy can have INR 2 to ≤ 3;
  • Pregnant women of childbearing age need negative pregnancy test results. Subjects with reproductive capacity (and their partners) voluntarily use effective contraceptive methods during the treatment period and within 6 months after the last use of the investigational drug, such as condoms, oral or injectable contraceptives, etc.

Who cannot join

  • Within the 3 months prior to the administration of 177Lu-HX02, the subject had received radiotherapy drugs, including but not limited to: lutetium-177, radium-223, etc.
  • Within the 4 weeks prior to the administration of 177Lu-HX02, the subject had undergone major surgery, chemotherapy, biological therapy, immunotherapy, endocrine therapy (except hormone replacement), large molecule targeted therapy or off-label drug treatment. Within the 2 weeks prior to administration, the subject had received local palliative radiotherapy, traditional Chinese medicine with anti-tumor indications, small molecule targeted drugs.
  • Within 2 weeks prior to the first administration of the study drug, the subject had received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), albumin infusion and renal replacement therapy.
  • The medical history, computed tomography (CT) or magnetic resonance imaging (MRI) examination indicated the presence of central nervous system (CNS) metastatic lesions. Excluding: CNS metastatic lesions that have undergone radiotherapy or surgery, the subject did not use corticosteroids, anticonvulsants, or diuretics to control symptoms within 2 weeks prior to the first administration, the imaging indicated no progression or new onset of brain lesions, and there were no neurological symptoms.
  • Suffering from severe cardiovascular diseases, including but not limited to the following conditions:
  • Within 6 months prior to administration, suffered from acute myocardial infarction, unstable angina pectoris, or received coronary angioplasty or stent;
Show all 18Show fewer
  • New York Heart Association class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or within the lower limit of the normal range;
  • Uncontrolled hypertension (even with optimal treatment, with systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Baseline electrocardiogram QTcF interval prolonged (> 480 ms);
  • Currently has active infection and requires systemic anti-infection treatment (such as acute bacterial infection, tuberculosis, active hepatitis B/ C, active syphilis, etc.). Active hepatitis B is defined as: HBsAg or HBcAb test result is positive or exceeds the normal reference range, accompanied by hepatitis B virus titer > 2500 copies/mL or 500 IU/mL (excluding subjects who received anti-hepatitis B virus treatment for at least 14 days, HBV-DNA降至≤ 2500 copies/mL or 500 IU/mL， and agreed to continue treatment during the study period)； active hepatitis C is defined as： hepatitis C antibody positive or exceeds the normal reference range and HCV-RNA positive； syphilis-specific antibody positive； HIV antibody positive；
  • Non-infectious pneumonia requiring hormone treatment and radiation pneumonitis， hemodynamic-altering thrombotic events， active bleeding events or other serious complications；
  • Within the 5 years prior to the administration of 177Lu-HX02， the subject had any other active malignant tumors (excluding surgically resected and non-recurrent skin basal cell carcinoma， skin squamous cell carcinoma， superficial bladder cancer， local prostate cancer， in situ cervical cancer or other in situ cancers)；
  • Known to be allergic to the components of the study drug or its analogues；
  • Any person with difficulty in urination or urinary incontinence；
  • Suffering from claustrophobia or other conditions that prevent cooperation in PET/CT or SPECT/CT examinations；
  • Patients with mental disorders such as depression， schizophrenia， delusion， hallucination or suicidal ideation；
  • Pregnant women；
  • Other situations that the investigator considers the subject is not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Radiation Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors

This study is a single-center, open-label, phase I dose-escalation clinical trial, aiming to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, as well as the preliminary efficacy of 177Lu-HX02 injection in patients with advanced malignant solid tumors.

Being tested
177Lu-HX02 injection
Medical subject headings
Sarcoma, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • 177Lu-HX02 injectionDrug

    The subjects who met the inclusion and exclusion criteria were intravenously administered the test drug 177Lu-HX02 injection. The dosage was given according to their respective dose groups (50 mCi, 100 mCi, 150 mCi, 200 mCi), with a ±10% fluctuation in dosage. Each subject received one administration.

Study groups in NCT07920822
Study groupRoleWhat they receive
single ARMExperimentalNot described
Receives: Drug: 177Lu-HX02 injection

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

    Measured: 12months

Secondary outcomes (1)

  1. Use image analysis software to process SPECT/CT images,determine the standard uptake values (SUVmean and SUVmax) for the tumor .

    Measured: 12months

Timeline

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

  1. First posted6 Nov 2026
  2. Study start29 Jan 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920822
Sponsor's protocol ID
HX02-202501
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
6 Nov 2026
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 177Lu-HX02 injection in people with Soft Tissue Sarcoma and Non-small Cell Lung Cancer, run by Hexin (Suzhou) 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 15 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (time frame: 12months). 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 NCT07920822.

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 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in