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Prostate CancerPhase 1/2NCT06970119

A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate INR102 Injection in Patients With Prostate Cancer

A Phase 1/2 study testing INR102 injection in people with Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
INR102 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
14 May 2025to 22 Oct 2029
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 subjects 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 least one of the following criteria: Progression in PSA was defined as an increase in serum PSA measured twice, one week apart, with the initial value being ≥ 2.0 ng/mL. Soft tissue progression as defined by RECIST v1.1. Bone progression: two new lesions (PCWG3).
  • Subjects 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 purpurane drugs should not exceed two regimens, defined as at least two cycles of treatment with purpurane agents. If the investigator determines that a subject is unsuitable for receiving or re-initiating paclitaxel-based therapy due to reasons such as poor physical condition or intolerance to prior paclitaxel regimens, or if the subject declines further paclitaxel treatment, they may still be enrolled in the study.
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  • Imaging examinations conducted during the screening period of the subjects (within 4 weeks prior to administration) confirmed the presence of one or more metastatic lesions.
  • Subjects 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 blood product transfusions or granulocyte colony-stimulating factor (G-CSF), should have been administered within 14 days prior to the screening period examination.
  • Liver function: Total bilirubin ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. In cases of liver metastasis, ALT and AST levels ≤5×ULN are acceptable.
  • Kidney function: Serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) ≥60 mL/min (calculated using the Cockcroft-Gault formula). Serum albumin must be ≥3g/dL.
  • 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 transferring the study drug to their partners via semen. Furthermore, participants are required to refrain from donating sperm during this specified timeframe.

Who cannot join

  • Within six months prior to the first study treatment, subjects had received systemic or local radioisotope therapy. Subjects who have undergone any prior treatment targeting PSMA are ineligible for participation in the study.
  • Within 28 days before the first study treatment or within five half-lives of the agent (whichever is shorter), subjects received systemic anti-tumor treatments, including chemotherapy, immunotherapy, small molecule inhibitors, or cell therapy. Within 28 days before the first study treatment, subjects received external beam radiotherapy, with the exception of palliative radiotherapy. Within two weeks before the first study treatment, subjects had received traditional Chinese medicine therapies with anti-tumor indications.
  • Subjects 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 extensive bone marrow (> 25%) in the past are ineligible. Within 28 days prior to the first study treatment, subjects must not have received blood transfusion therapy. -
  • The subjects' 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, subjects must not have participated in other interventional clinical trials or be within five half-lives of the investigational drug, whichever is shorter.
  • Subjects 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.
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  • Subjects with untreated active brain metastases or meningeal metastases are ineligible. However, subjects with previously treated active brain metastases (e.g., surgery, radiotherapy, gamma knife) who do not require steroid or anticonvulsant therapy, exhibit no symptoms, and demonstrate stable neurological function for at least 28 days may participate.
  • Subjects with symptomatic spinal cord compression or imaging evidence suggesting imminent spinal cord compression are eligible (subjects who have undergone treatment for spinal cord compression, including surgery and/or radiotherapy, and are currently stable without neurological deficits, may participate in the study);
  • Bone scans conducted during the screening period reveal findings suggestive of supra-bone imaging abnormalities;
  • Subjects with claustrophobia or other conditions, such as an inability to lie flat or remain still, that preclude tolerance of imaging examination procedures;
  • Subjects with poor venous conditions, as assessed, making frequent collection of pharmacokinetic (PK) blood samples impractical (applicable only to subjects 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 subjects' participation in the study, will be excluded. This includes but is not limited to: New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, long QT syndrome or a confirmed family history of long QT syndrome, severe infections requiring intravenous administration of antibiotics, antifungals, or antivirals according to clinical guidelines, active hepatitis B (positive for HBsAg and/or HBcAb with HBV-DNA > 500 IU/mL or > 2000 copies/mL), or hepatitis C (positive for anti-HCV with HCV-RNA above the lower limit of detection).
  • Other malignant tumors diagnosed as potentially affecting life expectancy or interfering with disease evaluation will be considered. Subjects with a history of other malignant tumors prior to enrollment, who have received adequate treatment and have remained disease-free and treatment-free for more than three years, are eligible to participate in the study. Additionally, patients with fully treated non-melanoma skin cancer and superficial bladder cancer are also eligible for participation.
  • Participants with uncontrollable bladder outlet obstruction or urinary incontinence are excluded. Note: Subjects with bladder outlet obstruction or urinary incontinence that can be managed through the best available standard treatment (e.g., absorbent pads, catheterization, etc.) are eligible for inclusion in the study.
  • 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.

Trial locations and contacts

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

Dong Yuan contact

+86-18611999529

yuandong@ynby.cn

China2 sites, 2 recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300000

    Dong Dai, Doctor of Medicine (M.D.), +86-18622000577, xiandao5502@163.com

    Xin Yao, Doctor of Medicine (M.D.), +86-18600001103, yaoxintjmuch@126.com

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214000

    Chunjing Yu, Doctor of Medicine (M.D.), +86-15312238622, ycj-wxd1978@163.com

    Chunjing Yu, Doctor of Medicine (M.D.)

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Non-randomized Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and Preliminary Efficacy of INR102 Injection in Patients With Prostate-specific Membrane Antigen (PSMA)-Positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

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.

Read the detailed description

This is a Phase I/IIa, open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), radiation dosimetry, and preliminary efficacy of multiple fixed doses of INR102 in subjects with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with at least one novel androgen receptor pathway inhibitor (ARPI) and taxane-based therapies. Based on the collected data, including potential dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and therapeutic doses of similar products, the recommended Phase II dose (RP2D) was determined. Subsequently, a dose-expansion cohort study was conducted using RP2D to further assess the preliminary efficacy, safety, tolerability, PK profile, and radiation dosimetry characteristics of INR102 in the same patient population.

Conditions
Prostate Cancer
Being tested
INR102 injection
Keywords
Prostate Cancer, INR102
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • INR102 injectionDrug

    INR102 injection is a lutetium-177 ([177Lu])-labeled radiopharmaceutical agent targeting prostate-specific membrane antigen (PSMA). It is clinically indicated for the treatment of patients with PSMA-positive prostate cancer.

Study groups in NCT06970119
Study groupRoleWhat they receive
RP2DExperimentalBased on the collected data, including potential dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and therapeutic doses of similar products, the recommended Phase II dose (RP2D) was determined.
Receives: Drug: INR102 injection

What is being measured

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

  1. Validity Index

    The proportion of subjects whose PSA decreased by ≥50% relative to the baseline and was confirmed by the second (next) PSA measurement after 4 weeks.

    Measured: 2 years after the initial study treatment

Timeline

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

  1. First posted14 May 2025
  2. Study start14 May 2025
  3. Primary completion20 Jun 2029 (estimated)
  4. Study completion22 Oct 2029 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970119
Sponsor's protocol ID
INR102-Ⅰ/Ⅱa-01
Other IDs
CTR20251605
Status last verified
May 2025
First submitted
27 Apr 2025
Last updated
7 Jan 2026
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 1/2 study testing INR102 injection in people with Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 2 sites 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 14 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Dong Yuan (+86-18611999529, yuandong@ynby.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity Index (time frame: 2 years after the initial study treatment). 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 NCT06970119.

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 7 Jan 2026.

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Clinical Trial NCT06970119 | AzTrials