PT-112 Injection for Advanced Prostate Cancer

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

109 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is complete and no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

Research Team

Daniel D. Karp, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+