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

NCT06553846 | Not Yet Recruiting Phase 1

• 1 other identifier: [177Lu]-FAP-75-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumors

Keywords

solid tumors; FAP; Radionuclide therapy

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate(ORR)

  Evaluated by RECIST1.1

  Up to approximately 12 months

• Adverse events(AEs)

  AEs , are assessed by NCI-CTCAE v5.0

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

• Dose Limiting Toxicity(DLT)

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

  within 6 weeks from the first drug administration

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Overall survival(OS)

  Up to approximately 12 months

• Disease Control Rate(DCR)

  Up to approximately 12 months

• Duration of Response(DoR)

  Up to approximately 12 months

• Progression free survival (PFS)

  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

• Radiation dosimetry

  Up to 6 weeks

Study Arms (1)

treatment group

EXPERIMENTAL

Lutetium \[177Lu\]-FAP-75 accumulates at the tumor site, and beta rays act on surrounding tumor cells, causing tumor cell apoptosis.

Drug: Lutetium [177Lu]-FAP-75

Interventions

Lutetium [177Lu]-FAP-75 DRUG

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

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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);

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Lutetium

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Miaoyan Wei, Professor

CONTACT

02164175590; weimiaoyan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 14, 2024
• Study Start: August 19, 2024
• Primary Completion: February 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

CN (1)