KPG-121 + Standard Therapies for Prostate Cancer

No longer recruiting at 5 trial locations

Overseen By YONG GUO, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Kangpu Biopharmaceuticals, Ltd.

Must be taking: Enzalutamide, Abiraterone, Apalutamide

Must not be taking: Prohibited medications

Disqualifiers: Chemotherapy, Radiation, Seizure, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 6 cycles (28-day per cycle)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KPG-121 for men with prostate cancer that no longer responds to standard hormone therapies. The researchers aim to determine if KPG-121 is safe and effective when combined with other cancer medications, such as Abiraterone (Zytiga or Yonsa), Apalutamide (Erleada), and Enzalutamide (Xtandi). Men with prostate cancer, whether or not it has spread, who have maintained a stable dose of certain medications for at least four weeks, may qualify for this study. The trial targets individuals who can swallow pills and attend regular check-ups. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that current use of or anticipated requirement of prohibited medications is an exclusion criterion. It is best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that KPG-121 is likely to be safe for humans?

Research shows that KPG-121, a new treatment, has undergone safety testing in earlier studies. In one study, 12 patients experienced a total of 88 treatment-related side effects, meaning 75% of the patients had some side effects. Additionally, eight serious side effects were reported.

These studies are in the early stages and focus on the body's reaction to the treatment and potential side effects. This helps researchers understand KPG-121's safety before administering it to more patients. These early studies aim to find the best dose that patients can handle with the fewest side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KPG-121 because it offers a novel approach to treating castration-resistant prostate cancer (CRPC). Unlike traditional treatments like Enzalutamide, Abiraterone, and Apalutamide, which primarily target androgen receptors, KPG-121 has a unique mechanism of action that researchers believe may enhance antitumor activity. This innovative approach could potentially improve treatment outcomes and offer new hope for patients who have become resistant to existing therapies.

What evidence suggests that KPG-121 might be an effective treatment?

Research has shown that KPG-121, which participants in this trial will receive, shows promise for treating advanced prostate cancer that no longer responds to hormone therapy. In earlier studies, patients tolerated KPG-121 well, and it demonstrated significant positive effects. Specifically, doses of 1.5 mg and 2.5 mg helped control cancer growth. This treatment works by adjusting certain proteins that influence cancer cell survival. These early findings suggest that KPG-121 could be a helpful treatment option for patients with this type of prostate cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Yao Wang

Principal Investigator

Kangpu Biopharmaceuticals, Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to swallow and retain orally administered medication;

Histologically or cytologically confirmed diagnosis of prostate carcinoma;

Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;

Exclusion Criteria

You have a severe medical condition affecting your brain or nervous system.

You have received chemotherapy, radiation or experimental immunotherapy within the last 4 weeks. Limited radiation to control bone pain is allowed.

You cannot take certain medications during the study, including experimental drugs, anti-cancer treatments, and certain herbs or supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

3+3 dose escalation design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121

28 days

Cycle-1 (up to 28-day)

Treatment

Participants receive KPG-121 capsules at different dose levels for 21 days in 28-day treatment cycles

Up to 6 cycles (28-day per cycle)

Cycle-1 to Cycle-6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone
• Apalutamide
• Enzalutamide
• KPG-121

How Is the Trial Designed?

Group I: KPG-121 Experimental Treatment 1 Intervention

Safety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days

Who Is Running the Clinical Trial?

Kangpu Biopharmaceuticals, Ltd.

Lead Sponsor

Trials

4

Recruited

150+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e17054

KPG-121, a novel cereblon modulator, in patients with ... Conclusions: KPG-121 1.5 mg and 2.5 mg were generally well tolerated and showed meaningful clinical activity based on the preliminary efficacy ...

2. targetedonc.com targetedonc.com/view/fda-greenlights-phase-2-3-trial-of-kpg-121-abiraterone-in-mcrpc

FDA Greenlights Phase 2/3 Trial of KPG-121/Abiraterone in ... An earlier phase 1 study (NCT03569280) evaluated KPG-121 and showed a favorable safety profile and promising early signs of efficacy, with a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03569280

NCT03569280 | Evaluation of Safety and Efficacy of KPG- ... This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.

4. urologytimes.com urologytimes.com/view/fda-approves-phase-2-3-trial-of-kpg-121-plus-abiraterone-in-mcrpc

FDA approves phase 2/3 trial of KPG-121 plus abiraterone ... “KPG-121 1.5 mg and 2.5 mg were generally well tolerated and showed meaningful clinical activity based on the preliminary efficacy data in mCRPC ...

5. aacrjournals.org aacrjournals.org/cancerres/article/80/16_Supplement/5327/644081/Abstract-5327-KPG-121-a-novel-CRBN-modulator

Abstract 5327: KPG-121, a novel CRBN modulator, potently ... KPG-121, a novel CRBN modulator, potently inhibits growth of metastatic castration resistant prostate cancer as a single agent or in combination with androgen ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03569280/

Clinical Trial: NCT03569280 This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles (21 days on and 7 ...