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A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

ConditionmCRPC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJinming Zhang

About this trial

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have the ability to understand and sign an approved informed consent form (ICF).

Patients must be >= 18 and <＝80 years of age.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Patients must have a life expectancy >6 months.

Disqualifiers

Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.

Known other malignancies.

Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.

Known hypersensitivity to the components of the study therapy or its analogs.

Trial design

Design model

Single group

Treatments tested in this trial

  • [177Lu]Lu-PSMA-XT

    Drug

    \[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: [177Lu]Lu-PSMA-XTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.

Time frame
Through study completion, assessed up to 2 years
2

Dose-limiting toxicity（DLT）

Incidence and severity of dose-limiting toxicities.

Time frame
Through study completion, assessed up to 2 years
3

Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection

Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered \[177Lu\]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.

Time frame
From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months

Secondary outcomes

1

Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)

Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline.

Time frame
Through study completion, assessed up to 2 years.
2

Prostate-specific Antigen 50 (PSA50) Response

PSA50 response was defined as the proportion of participants who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.

Time frame
Through study completion, assessed up to 2 years.
3

Time to PSA progression

PSA progression was defined as: 1) Where a decline from baseline was documented, date that a \>= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a \>= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.

Time frame
Through study completion, assessed up to 2 years.
4

Radiographic Progression-free Survival (rPFS)

Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.

Time frame
Through study completion, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinming Zhang

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Sinotau Pharmaceutical Group

Collaborator

Source ClinicalTrials.gov
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