What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as tyrosine kinase inhibitors (e.g., imatinib, dasatinib) and other novel agents, often have side effects including cytopenias (low blood cell counts), gastrointestinal issues (nausea, diarrhea), hepatic toxicity, and pulmonary toxicity. Other potential side effects can include mucocutaneous ulcers, peripheral neuropathy, and increased risk of infections. Specific agents may also cause unique side effects, such as severe dizziness with imatinib or hyperglycemia with certain chemotherapy regimens.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and novel agents for the treatment of blood cancers. For instance, romiplostim was approved in 2021 for acute radiation syndrome based on animal studies. Additionally, brexucabtagene autoleucel, a CAR-T cell therapy directed against CD19, has been approved for relapsed or refractory mantle cell lymphoma, demonstrating high response rates. Other notable approvals include ibrutinib for relapsed refractory hairy cell leukemia and various tyrosine kinase inhibitors like dasatinib and imatinib for Philadelphia chromosome-positive leukemias. These approvals highlight the ongoing advancements in targeted therapies and novel agents for hematological malignancies.

What other types of research exist?

Promising novel alternatives to KPG-818 for blood cancer patients include: <ol> <li>Venetoclax combined with low-dose cytarabine for acute myeloid leukemia (AML).</li> <li></li> </ol> Ivosidenib for newly diagnosed IDH1-mutant AML. 3. Enasidenib for mutant IDH2 relapsed or refractory AML. 4. Gemtuzumab Ozogamicin for older patients with newly diagnosed AML unsuitable for intensive chemotherapy. 5. Acalabrutinib for relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia (CLL). 6. Obinutuzumab combined with chlorambucil for previously untreated CLL.

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Other

KPG-818 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Kangpu Biopharmaceuticals, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.

Must not have

Myocardial infarction within 12 months prior to initiating IP

Received live attenuated vaccine within 4 weeks of first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called KPG-818 for patients with certain blood cancers. The drug is taken by mouth and researchers will check its safety and effectiveness. They will monitor how the drug moves through the body and its impact on cancer cells.

Who is the study for?

Adults over 18 with certain blood cancers (like multiple myeloma, lymphomas) who have tried all approved treatments without success can join. They must be able to consent and follow the study plan, have measurable disease, meet specific health criteria, and use two contraception methods if of childbearing potential.

What is being tested?

The trial is testing KPG-818's safety and how it affects the body at different doses in patients with various blood cancers. It's an early-stage study (phase 1), involving about 30 people to see how well they tolerate escalating doses.

What are the potential side effects?

Since this is a phase 1 trial primarily focused on safety and dosage levels, specific side effects are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with a specific type of blood or lymph node cancer.

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My disease can be measured or assessed by doctors.

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My cancer has returned or is not responding to treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack in the last year.

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I have not received a live vaccine in the last 4 weeks.

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I have been diagnosed with plasma cell leukemia.

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I have side effects from cancer treatment that are mild or better.

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I cannot or do not want to follow the required blood clot prevention treatment.

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I haven't taken PD-1 or PD-L1 inhibitors in the last 3 months.

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I am currently pregnant, nursing, or breastfeeding.

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I haven't had major surgery or serious injuries in the last 6 weeks and don't plan any during the study.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I do not have unstable or poorly controlled chest pain.

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I have been diagnosed with congestive heart failure.

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I have active brain metastases or cancer in the lining of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended Phase 2 Dose (RP2D)

Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary study objectives

Assessment of clinical activity: disease control rate (DCR).

Assessment of clinical activity: event-free survival (EFS), and transplantation rate (TR).

Assessment of clinical activity: objective response rate (ORR).

+2 more

Other study objectives

Biomarkers of KPG-818

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

KPG-818 dose escalation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KPG-818

2019

Completed Phase 1

~40

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers, such as targeted therapies and novel agents, work by interfering with specific molecules involved in cancer cell growth and survival. Tyrosine kinase inhibitors (TKIs) block enzymes that signal cancer cells to proliferate, while monoclonal antibodies target specific antigens on cancer cells, marking them for immune destruction. Proteasome inhibitors disrupt protein degradation within cancer cells, leading to cell death. These targeted approaches are important for blood cancer patients as they provide more precise treatment options with potentially fewer side effects compared to traditional chemotherapy.