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New treatment option for Prostate Cancer
Official title A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT06970119
What this study is testing
What is INR102 injection?
INR102 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of INR102 injection in patients with prostate cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willingly participate in this clinical trial, demonstrate a clear understanding of the research procedures, and be capable of signing the informed...
- Be at least 18 years of age at the time of signing the informed consent form.
- Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine or small cell features).
- A positive result on the 18F-PSMA-137 PET/CT scan is required.
- The serum testosterone levels of the people must be maintained at a castrate level (\< 50 ng/dL or \< 1.7 nmol/L). Despite maintaining castrate-level...
You likely can't join if
- Within six months prior to the first study treatment, people had received systemic or local radioisotope therapy. people who have undergone any prior...
- Within 28 days before the first study treatment or within five half-lives of the agent (whichever is shorter), people received systemic anti-tumor...
- people who have experienced Grade 4 myelosuppression following prior anti-tumor therapy, or Grade 3 myelosuppression requiring more than six weeks...
- The people' prior anti-tumor treatment toxicity had not resolved to CTCAE grade ≤1 (NCI CTCAE v5.0), with the exception of alopecia (all grades...
- Within 28 days prior to the first study treatment, people must not have participated in other treatment clinical trials or be within five half-lives...
- people with a documented history of hypersensitivity reactions to 18F-PSMA-137 and/or 177Lu-PSMA-137 drugs, their excipients, or chemically similar...
See the full eligibility criteria
Who can join
- Willingly participate in this clinical trial, demonstrate a clear understanding of the research procedures, and be capable of signing the informed consent form in person.
- Be at least 18 years of age at the time of signing the informed consent form.
- Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine or small cell features).
- A positive result on the 18F-PSMA-137 PET/CT scan is required.
- The serum testosterone levels of the people must be maintained at a castrate level (\< 50 ng/dL or \< 1.7 nmol/L). Despite maintaining castrate-level serum testosterone, disease progression was confirmed based on at...
- people who have previously failed treatment with at least one novel androgen receptor pathway inhibitor (e.g., enzalutamide, apalutamide, and/or abiraterone) and taxane-based therapies are eligible. Prior exposure to...
- Imaging examinations conducted during the screening period of the people (within 4 weeks prior to administration) confirmed the presence of one or more metastatic lesions.
- people must demonstrate adequate organ function as follows: Bone marrow reserve: Absolute neutrophil count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin level ≥90g/L. No relevant supportive treatments, including...
- The ECOG PS score must range from 0 to 2.
- Expected survival should exceed six months.
- Participants must use condoms during sexual intercourse throughout the study period and for 18 weeks following the administration of the last dose of the investigational product to prevent conception and avoid...
What rules you out
- Within six months prior to the first study treatment, people had received systemic or local radioisotope therapy. people who have undergone any prior treatment targeting PSMA are ineligible for participation in the...
- Within 28 days before the first study treatment or within five half-lives of the agent (whichever is shorter), people received systemic anti-tumor treatments, including chemotherapy, immunotherapy, small molecule...
- people who have experienced Grade 4 myelosuppression following prior anti-tumor therapy, or Grade 3 myelosuppression requiring more than six weeks for recovery, or who have received external radiotherapy targeting...
- The people' prior anti-tumor treatment toxicity had not resolved to CTCAE grade ≤1 (NCI CTCAE v5.0), with the exception of alopecia (all grades permitted) and peripheral neuropathy (requiring recovery to grade ≤2).
- Within 28 days prior to the first study treatment, people must not have participated in other treatment clinical trials or be within five half-lives of the investigational drug, whichever is shorter.
- people with a documented history of hypersensitivity reactions to 18F-PSMA-137 and/or 177Lu-PSMA-137 drugs, their excipients, or chemically similar agents are excluded.
- people with untreated active brain metastases or meningeal metastases are ineligible. However, people with previously treated active brain metastases (e.g., surgery, radiotherapy, gamma knife) who do not require steroid...
- people with symptomatic spinal cord compression or imaging evidence suggesting imminent spinal cord compression are eligible (people who have undergone treatment for spinal cord compression, including surgery and/or...
- Bone scans conducted during the screening period reveal findings suggestive of supra-bone imaging abnormalities;
- people with claustrophobia or other conditions, such as an inability to lie flat or remain still, that preclude tolerance of imaging examination procedures;
- people with poor venous conditions, as assessed, making frequent collection of pharmacokinetic (PK) blood samples impractical (applicable only to people participating in the PK study).
- The concurrent presence of severe and/or uncontrollable diseases or conditions (as determined by the central researcher), which may compromise people' participation in the study, will be excluded. This includes but is...
- Other malignant tumors diagnosed as potentially affecting life expectancy or interfering with disease evaluation will be considered. people with a history of other malignant tumors prior to enrollment, who have received...
- Participants with uncontrollable bladder outlet obstruction or urinary incontinence are excluded. Note: people with bladder outlet obstruction or urinary incontinence that can be managed through the best available...
- History of any physical or mental health condition deemed by the investigator to potentially compromise the safety or adherence to the drug treatment in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuxi, Jiangsu, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuxi, Jiangsu, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.