PT-112 Injection for Advanced Prostate Cancer

Not currently recruiting at 24 trial locations

Overseen By Promontory Therapeutics

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Phosplatin Therapeutics

Must not be taking: Chemotherapy, Immunomodulatory, Corticosteroids, others

Disqualifiers: Inadequate bone marrow, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new drug, PT-112 Injection, for men with advanced prostate cancer that has spread and is resistant to standard hormone treatments. Researchers seek to determine the treatment's safety, how the body processes it, and the most effective dose. The trial includes different groups receiving varying doses of the drug. Men whose prostate cancer has not responded to at least three previous treatments and who show signs of cancer spreading may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

You will need to stop taking any chemotherapy, immunomodulatory drugs, hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factors at least 14 to 21 days before starting the study drug. The trial protocol does not specify other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PT-112 is safe, based on earlier studies. These studies found that PT-112 works well and is generally easy for patients to tolerate. Evidence indicates that it helps kill cancer cells without causing major harm to patients. Due to these positive results, PT-112 has been approved for further testing, meaning most patients do not experience severe side effects.

While some side effects can occur, they are usually manageable. Patients should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about PT-112 injections for advanced prostate cancer because they offer a new approach compared to traditional hormone therapies and chemotherapy. PT-112 works by targeting cancer cells with a unique mechanism called immunogenic cell death, which helps the immune system recognize and attack cancer cells more effectively. Unlike standard treatments, PT-112 is administered through an intravenous infusion, allowing for precise dosing and potentially fewer side effects. This innovative method could lead to more effective and safer treatment options for patients with advanced prostate cancer, sparking much anticipation in the medical community.

What evidence suggests that PT-112 Injection might be an effective treatment for advanced prostate cancer?

Research shows that PT-112 holds promise for treating advanced prostate cancer. It stops cancer cells from growing and causes them to die, while sparing healthy cells. Studies have shown that PT-112 can shrink tumors and help control the disease. Additionally, it strengthens the immune system, enhancing the body's ability to fight cancer. These findings have led to the approval of more trials, indicating confidence in its potential. Participants in this trial will receive PT-112 in varying dosages across different treatment arms to further evaluate its effectiveness. ^{2 3 4 5 6}

Who Is on the Research Team?

Daniel D. Karp, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including metastatic castrate-resistant prostate cancer, who have limited treatment options. Participants must be in good physical condition (ECOG 0-1), have stable brain metastases if present, and adequate organ function. They can't join if they've had extensive chemotherapy, uncontrolled heart issues, recent major surgery or radiotherapy, active infections or certain previous cancers.

Inclusion Criteria

My prostate cancer was confirmed by a lab test.

My organ functions are within normal ranges.

My prostate cancer has spread and is resistant to hormone therapy.

Exclusion Criteria

More than 25% of my bone marrow has been exposed to radiation.

I have not had major surgery in the last 28 days.

I haven't taken any immune-modifying, cancer hormone treatments, steroids, or growth factors in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and pharmacokinetics

Completed

Dose Expansion

Study of PT-112 in patients with thymoma, thymic carcinoma, and metastatic castrate-resistant prostate cancer (mCRPC)

Ongoing for mCRPC cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• PT-112 Injection

Trial Overview The study tests PT-112 Injection's safety and how the body processes it. It has two parts: an initial phase to find the highest dose patients can tolerate without severe side effects (completed) and a second phase focusing on specific cancers like thymoma/thymic carcinoma and metastatic prostate cancer.

How Is the Trial Designed?

Group I: Arm 3: PT-112 injection Experimental Treatment 1 Intervention

Arm 3: PT-112 Injection, administered by intravenous infusion, 360 mg/m2 for two doses, 250 mg/m2 for subsequent doses

Group II: Arm 2: PT-112 injection Experimental Treatment 1 Intervention

Arm 2: PT-112 Injection, administered by intravenous infusion, biweekly 250 mg/m2

Group III: Arm 1: PT-112 injection Experimental Treatment 1 Intervention

Arm 1: PT-112 Injection, administered by intravenous infusion, biweekly 360 mg/m2

Who Is Running the Clinical Trial?

Phosplatin Therapeutics

Lead Sponsor

Trials

3

Recruited

200+

Promontory Therapeutics Inc.

Lead Sponsor

Trials

3

Recruited

200+

Citations

1. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/160934-asco-2025-preliminary-phase-2-results-of-pt-112-monotherapy-in-late-line-metastatic-castration-resistant-prostate-cancer-mcrpc.html

ASCO 2025: Preliminary Phase 2 Results of PT-112 ... PT-112 is a novel therapy that inhibits ribosome biogenesis and induces immune activation, resulting in tumor regression and disease control in ...

2. cancernetwork.com cancernetwork.com/view/meeting-with-fda-successful-regarding-pt-112-in-mcrpc

Meeting With FDA “Successful” Regarding PT-112 in mCRPC The conclusion from that presentation was that PT-112 demonstrated strong immune activity. In the trial, blood samples were collected from 74 ...

3. targetedonc.com targetedonc.com/view/fda-oks-phase-3-trial-of-pt-112-in-mcrpc-following-successful-eop2-meeting

FDA Oks Phase 3 Trial of PT-112 in mCRPC Following ... PT-112 monotherapy advances to phase 3 trial in metastatic castration-resistant prostate cancer after positive FDA end of phase 2 meeting.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11470694/

Cancer cell-selective induction of mitochondrial stress and ... PT-112 demonstrated cancer cell selectivity, inhibiting cell growth and leading to cell death in prostate cancer cells without affecting the non-tumorigenic ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-pt-112-for-patients-with-advanced-prostate-cancer/

Study on the Safety and Effects of PT-112 for Patients with ... The purpose of the study is to evaluate the safety and effects of PT-112 in patients with advanced solid tumors, including prostate cancer. The ...

6. urologytimes.com urologytimes.com/view/enrollment-complete-in-phase-2-study-of-pt-112-in-mcrpc

Enrollment complete in phase 2 study of PT-112 in mCRPC "Data from our earlier Phase 1/2 studies have shown that PT-112 is clinically safe and active, and promotes immunogenic cancer cell death ...