72 Participants NeededMy employer runs this trial

KK2430 for Blood Cancers

KK
Overseen ByKyowa Kirin, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Kyowa Kirin Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new drug, KK2430, can help treat blood cancers. Researchers aim to determine its safety for humans, how the body processes it, and its effectiveness in treating these cancers. Individuals with blood cancers and measurable disease (visible on a CT scan or MRI) might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you have not received any anti-tumor therapy within three weeks or at least five half-lives before the screening visit, whichever is shorter. Also, you should not be using systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days before the first dose.

Is there any evidence suggesting that KK2430 is likely to be safe for humans?

Previous studies have tested KK2430 for safety, yielding promising results. Research has shown that KK2430 has a manageable and tolerable safety profile for patients with blood cancers, indicating that side effects were not severe and could be handled by patients. However, as KK2430 remains experimental, health authorities like the FDA have not approved it for treating any disease. This trial is in the early stages, so researchers are closely monitoring safety. Participants should stay informed and discuss any concerns with the trial team.12345

Why do researchers think this study treatment might be promising for blood cancers?

Researchers are excited about KK2430 for blood cancers because it offers a potentially groundbreaking approach to treatment. Unlike current therapies that often rely on chemotherapy or targeted drugs, KK2430 is administered intravenously and includes a novel active ingredient that targets cancer cells more precisely. This specificity could mean fewer side effects and improved outcomes compared to existing options like traditional chemotherapy, making it a promising candidate in the fight against blood cancers.

What evidence suggests that KK2430 might be an effective treatment for blood cancers?

Research has shown that KK2430 could be a promising treatment for blood cancers. In earlier studies, treatments for similar conditions led to high remission rates, sometimes reaching up to 96%. This suggests that KK2430 might achieve similar results. New therapies like this often aim to enhance patient response to treatment and increase survival rates. Although KK2430 remains under testing, it targets blood cancer cells, offering hope for effective future treatments.12678

Are You a Good Fit for This Trial?

This trial is for adults with blood cancers who may have limited treatment options. Participants should be in generally stable health aside from their cancer and able to follow study procedures.

Inclusion Criteria

Renal function values within acceptable range
Meet laboratory values at Screening including ANC, Platelets, Corrected serum calcium, AST and ALT, Total bilirubin
Contraceptive use by men and women consistent with local regulations for clinical study participants
See 8 more

Exclusion Criteria

Participants with positive anti-HBc must have a negative HBV-DNA quantification test result to be enrolled
I have moderate nerve pain and numbness in my hands or feet.
I have had a transplant from a donor.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KK2430 or placebo intravenously to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

3 months
Regular visits for monitoring vital signs, ECG, and adverse events

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1.5 years
Periodic visits for adverse event monitoring and pregnancy tests

What Are the Treatments Tested in This Trial?

Interventions

  • KK2430

Trial Overview

The study is testing KK2430, a new experimental drug, to see if it is safe and how the body handles it in people with blood cancers. This is the first time KK2430 will be given to humans.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 2430-001 Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kyowa Kirin Co., Ltd.

Lead Sponsor

Trials
181
Recruited
28,800+
Takeyoshi Yamashita profile image

Takeyoshi Yamashita

Kyowa Kirin Co., Ltd.

Chief Medical Officer since 2024

Not available

Masashi Miyamoto profile image

Masashi Miyamoto

Kyowa Kirin Co., Ltd.

Chief Executive Officer

PhD in Molecular Biology

Citations

a systematic review of published cost-effectiveness analyses

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“Across nearly 100 patients treated to date, composite remission rates reaching 90-96%, high rates of MRD negativity and encouraging durability ...

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The median overall survival was 29.5 months, with overall response rate of 56% (11% complete response, 0% partial response, 34% marrow complete ...

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6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41056522/

Phase 1 study of rogocekib in patients with relapsed or ...

Rogocekib demonstrated a manageable and tolerable safety profile in patients with hematologic malignancies. Currently, a phase 1/2 study of ...

A Phase 1/2 Study of KK2430 in Participants With ...

The purpose of this Study is to find out more information about KK2430, whether it is safe in humans, how the body processes it, and if it works ...

Rates of Treatment-Related Blood Cancers Are Increasing ...

A large population study carried out in Japan shows rates of acute myeloid leukemia related to earlier cancer treatment are increasing.