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New hope for tough prostate cancer: experimental combo targets resistant tumors

NCT ID NCT07389187

Disease control Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug (LC-K76) combined with an immunotherapy (Tislelizumab) and hormone therapy in 10 men with metastatic castration-resistant prostate cancer that has worsened after standard treatments. The goal is to check safety and see if the combination can shrink tumors or slow the disease. Participants take oral and intravenous medications for 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male, aged 18 to 85 years. 2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components. 3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and/or docetaxel chemotherapy. 4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT). 5. Serum testosterone at castration levels (\< 50 ng/dL or 1.75 nmol/L). 6. ECOG performance status ≤ 2. 7. Life expectancy \> 6 months. 8. Adequate bone marrow, hepatic, and renal function. 9. Willing to undergo biopsies before and during treatment Exclusion Criteria: 1. Lack of pathological evidence for prostate cancer. 2. Other primary malignant tumors active or requiring treatment within the past 3 years. 3. Has visceral metastases. 4. Poorly controlled diabetes after continuous insulin therapy. 5. Significant abnormalities in laboratory values at randomization (Hb \< 90 g/L; Neutrophils \< 1.5x10\^9/L; Platelets \< 75x10\^9/L; ALT/AST \> 2.5xULN; Bilirubin \> 1.5xULN; eGFR \< 60 mL/min/1.73m\^2) . 6. Severe cardiopulmonary disease or high-risk conditions. 7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1). 8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts. 9. History of severe drug allergies. 10. Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea). 11. Concurrent psychiatric or neurological conditions

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MCRPC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Changzheng hospital

    Shanghai, Shanghai Municipality, 201109, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.