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Solid TumorsPhase 1NCT06553846

A Clinial Trial of Lutetium [177Lu]-FAP-75 for the Treatment of Patients With Advanced Solid Tumors

A Phase 1 study testing Lutetium [177Lu]-FAP-75 in people with Solid Tumors, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the safety, tolerability, initial efficacy, pharmacokinetic profile and radiation dosimetry of lutetium [177Lu]-FAP-75 in the treatment of patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Solid Tumors
What is being tested?
Lutetium [177Lu]-FAP-75
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
19 Aug 2024to 18 Aug 2025
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the clinical trial, understand the research procedure and be able to sign the informed consent in person;
  • Age 18-80 years old (including 18 and 80 years old), gender is not limited;
  • ECOG score 0-1;
  • The expected survival period is not less than 4 months;
  • Subjects with solid tumors diagnosed histologically or cytologically at advanced stage (unresectable or metastatic) after failure of standard treatment (disease progression or intolerance) or lack of effective treatment are enrolled in this study.
  • There must be at least one measurable target lesion (according to RECIST V1.1);
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  • Positive lesion uptake in FAP PET/CT imaging
  • The level of vital organ function meets the following requirements :
  • Neutrophil ≥1.5×109/L;
  • Platelets ≥100×109/L;
  • Hemoglobin ≥90g/L;
  • Total bilirubin ≤1.5×ULN; If there is biliary obstruction or Gilbert syndrome, total bilirubin ≤3×ULN;
  • ALT and AST≤3 x ULN; If liver metastasis exists, ALT and AST≤5×ULN;
  • Serum albumin ≥30g/L;
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockcroft-Gault formula);
  • INR≤1.5×ULN and APTT≤1.5×ULN (for subjects not receiving anticoagulant therapy, stable therapy dose is required for subjects receiving anticoagulant therapy).
  • Women of childbearing age must undergo a blood pregnancy test within 72 hours before the first dosing, must be non-lactating.

Who cannot join

  • Known significant weight loss (>10%) within 28 days prior to signing the informed consent.
  • Prior and follow-up treatment:
  • Received any radionuclide therapy or radiotherapy within 6 months before enrollment.
  • Prior treatment with any FAP target nuclide.
  • Received anti-tumor therapy such as surgery (except diagnostic biopsy and drainage of serosal effusion), chemotherapy, immunotherapy, and monoclonal antibodies within 4 weeks prior to admission; received anti-tumor endocrine drugs within 2 weeks; received nitrosourea or mitomycin chemotherapy within 6 weeks; eluted oral targeted therapy drugs with less than 5 half-lives or 4 weeks (whichever is shorter).
  • Received any other investigational drug treatment within 4 weeks prior to enrollment.
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  • Any surgical procedures requiring general anesthesia and significant incisions (e.g., central venous access, percutaneous feeding tube insertion) within 6 weeks of enrollment (expected surgery).
  • Combined with the following diseases:
  • Patients with meningeal metastasis or diffuse central nervous system metastasis or active central nervous system metastasis who require any radiotherapy, gamma knife, surgery, or medication to control the symptoms of metastasis 1 month prior to screening are excluded. Patients with a limited number of stable central nervous system metastases could be enrolled.
  • severe urinary incontinence, hydronephrosis, and severe urination dysfunction. Note: Subjects with bladder outflow tract obstruction that can be controlled with the best available standard of care are eligible for study participation.
  • Co-active hepatitis B, hepatitis C.
  • Known to have acquired immune deficiency syndrome (AIDS) or tested positive for HIV.
  • Active syphilis infection.
  • Known allergy to components of the investigatory drug or its analogues.
  • Malignancies outside the target tumor species that are expected to alter life expectancy or may interfere with disease assessment within the first 5 years of enrollment. The exception is for cured malignancies with a low risk of metastasis and death, such as non-metastatic skin basal cell carcinoma or skin superficial squamous cell carcinoma.
  • Serious infections occurred within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc., and signs and symptoms of infection within 2 weeks prior to enrollment requiring intravenous antibiotic treatment (except for prophylactic antibiotic use).

Trial locations and contacts

1 site in 1 country.

Miaoyan Wei, Professor contact

02164175590

weimiaoyan@fudanpci.org

China1 site

  • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center;Pancreatic Cancer Institute, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Miaoyan Wei, Professor, 02164175590, weimiaoyan@fudanpci.org

    Xianjun Yu, Professor

Other trials in China

About this study

Official title: A Clinical Trial on Pharmacokinetics and Radiation Dosimetry, Safety and Preliminary Efficacy Evaluation of Lutetium [177Lu]-FAP-75 for the Treatment of Patients With Advanced Solid Tumors

To explore the safety, tolerability, initial efficacy, pharmacokinetic profile and radiation dosimetry of lutetium [177Lu]-FAP-75 in the treatment of patients with advanced solid tumors.

Read the detailed description

This is a prospective, open, dose-exploring clinical study of Lutetium [177Lu]-FAP-75 in the treatment of patients with advanced solid tumors. The study was divided into two stages, the first stage was dose exploration study, and the second stage was case expansion study. In the first phase of this study, several dose groups were designed. Subjects may receive only one of these doses and may not receive multiple doses in the same subject. The drug was administered every 6 weeks, and the DLT observation period was 6 weeks after the first dose. Firstly, the first dose safety introduction of human body was carried out. Based on the results of the preclinical study of this product, an appropriate number of enrolled subjects in the first and second stages were selected to enter the PK and radiation dosimetry detection groups. After the end of the DLT observation period, subjects who met the criteria for continued dosing were allowed to continue to receive the investigational drug therapy for subsequent cycles. For all participants enrolled in this study, the study process included a screening period, a treatment period and a follow-up period. In the course of the trial, extended studies of other tumor species can be conducted based on new advances and results of clinical studies of similar drugs to further explore the safety, tolerability and initial effectiveness of specific tumor types.

Conditions
Solid Tumors
Being tested
Lutetium [177Lu]-FAP-75
Keywords
solid tumors, FAP, Radionuclide therapy

What participants receive

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

  • Lutetium [177Lu]-FAP-75Drug

    Lutetium [177Lu]-FAP-75 will be administrated per dose level in which the patients are assigned.

Study groups in NCT06553846
Study groupRoleWhat they receive
treatment groupExperimentalLutetium [177Lu]-FAP-75 accumulates at the tumor site, and beta rays act on surrounding tumor cells, causing tumor cell apoptosis.
Receives: Drug: Lutetium [177Lu]-FAP-75

What is being measured

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

  1. Overall Response Rate(ORR)

    Evaluated by RECIST1.1

    Measured: Up to approximately 12 months

  2. Adverse events(AEs)

    AEs , are assessed by NCI-CTCAE v5.0

    Measured: From the first drug administration to within 90 days for the last drugs dose

  3. Dose Limiting Toxicity(DLT)

    Dose Limiting Toxicity are assessed by NCI-CTCAE v5.0

    Measured: within 6 weeks from the first drug administration

  4. Second-stage dose

    Second-stage dose is the recommend dose for the second stage of this trial which is determined by the safety profile of the first stage of this trial.

    Measured: through study completion, an average of 1 year

Secondary outcomes (5)

  1. Overall survival(OS)

    Time from the date of enrollment to date of death from any cause.

    Measured: Up to approximately 12 months

  2. Disease Control Rate(DCR)

    Evaluated by RECIST1.1

    Measured: Up to approximately 12 months

  3. Duration of Response(DoR)

    Evaluated by RECIST1.1

    Measured: Up to approximately 12 months

  4. Progression free survival (PFS)

    PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  5. Radiation dosimetry

    Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.

    Measured: Up to 6 weeks

Timeline

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

  1. First posted14 Aug 2024
  2. Study start19 Aug 2024 (estimated)
  3. Primary completion18 Feb 2025 (estimated)
  4. Study completion18 Aug 2025 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553846
Sponsor's protocol ID
[177Lu]-FAP-75-001
Status last verified
Aug 2024
First submitted
2 Aug 2024
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lutetium [177Lu]-FAP-75 in people with Solid Tumors, run by Fudan University 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 17 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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?

Results are not available in the source record.

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

Contact Miaoyan Wei, Professor (02164175590, weimiaoyan@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate(ORR) (time frame: Up to approximately 12 months). The study lists 4 primary outcomes in all. 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 NCT06553846.

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 14 Aug 2024.

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