KPG-818 for Blood Cancers

No longer recruiting at 10 trial locations

Overseen By Yao Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kangpu Biopharmaceuticals, Ltd.

Must not be taking: Immunosuppressants, PD-1/PD-L1 inhibitors

Disqualifiers: CNS metastases, Plasma cell leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KPG-818, an experimental drug, to determine its safety and effectiveness for people with certain blood cancers, such as multiple myeloma and various types of lymphoma. The goal is to assess how the body reacts to different doses and whether the treatment helps combat these cancers. Individuals who have not had success with other treatments for their blood cancer might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take strong inhibitors or inducers of CYP3A4/5, immunosuppressive medications, or have used certain investigational agents recently. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that KPG-818 is likely to be safe for humans?

Research has shown that KPG-818 is promising in terms of patient safety. One study found that KPG-818 was generally safe and well-tolerated, with no serious side effects. Another study demonstrated that KPG-818 was well-tolerated across different dose levels, suggesting patients handled the treatment well. Overall, early findings present a positive picture of KPG-818's safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KPG-818 for blood cancers because it works differently from current treatments like chemotherapy and targeted therapies. Most standard treatments attack cancer cells broadly or target specific proteins, but KPG-818 is designed to inhibit specific proteins involved in the growth and survival of cancer cells, potentially leading to fewer side effects and a more precise attack on the cancer. This unique mechanism could make it a promising option for patients who haven't responded well to existing therapies.

What evidence suggests that KPG-818 might be an effective treatment for blood cancers?

Research has shown that KPG-818 has strong anti-inflammatory effects and can stop cell growth in lab tests. This suggests it might help treat blood cancers by slowing or stopping cancer cell growth. In animal studies, KPG-818 also reduced disease symptoms. Although limited information exists from human studies, these early results indicate that KPG-818 could potentially treat various blood cancers. More research is needed to confirm its effectiveness in people. ^{1 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Kangpu Biopharmacuticals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to adhere to the study visit schedule and other protocol requirements.

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

Willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

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

I have used immunosuppressive medication within the last 14 days.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KPG-818 in combination with dexamethasone for MM or as monotherapy for other hematological malignancies. Treatment is divided into 6 cycles with dose escalation.

Up to 6 months

Dose Limiting Toxicity (DLT) Evaluation

DLT is assessed during Cycle 1 to determine the maximum tolerated dose.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KPG-818

Trial Overview 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.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

KPG-818 dose escalation

Who Is Running the Clinical Trial?

Kangpu Biopharmaceuticals, Ltd.

Lead Sponsor

Trials

4

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04283097

Safety, Tolerability and Pharmacokinetics Study of KPG- ... KPG-818 will be used in combination with dexamethasone in subjects with MM, and as monotherapy for other selected hematological malignancies. Each dose of KPG- ...

2. kangpugroup.com kangpugroup.com/media/3378.html

Kangpu Completes Patient Enrollment for Phase IIa ... KPG-818 demonstrated outstanding in vitro anti-inflammatory properties and a broad spectrum of anti-proliferative activities as well as ...

3. kangpugroup.com kangpugroup.com/media/3419.html

Kangpu Biopharmaceuticals to Present Results from Phase ... KPG-818 showed outstanding in vitro anti-inflammatory properties, broad spectrum of anti-proliferative activities, and remarkable in vivo ...

4. prnewswire.com prnewswire.com/news-releases/kangpu-biopharmaceuticals-to-present-results-from-phase-2a-of-kpg-818-in-sle-at-eular-2024-302168112.html

Kangpu Biopharmaceuticals to Present Results from Phase ... KPG-818 showed outstanding in vitro anti-inflammatory properties, broad spectrum of anti-proliferative activities, and remarkable in vivo ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04643067

NCT04643067 | Phase 1b/2a Study to Evaluate Safety and ... This is a Phase 1b/2a multicenter study to evaluate the safety, PK, PD, and clinical efficacy of KPG-818 in patients with SLE.

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04283097/

Clinical Trial: NCT04283097 This is a Phase 1 study to evaluate the safety, pharmacokinetics(PK), and preliminary clinical activity of KPG-818 as a single agent in adult subjects with ...

7. lupusnewstoday.com lupusnewstoday.com/news/kpg-818-found-safe-to-enter-clinical-trials-for-sle-blood-cancers/

KPG-818 Found Safe to Enter Clinical Trials for SLE, Blood ... Results showed that KPG-818 was generally safe and well-tolerated, with no safety issues reported. No serious adverse reactions or toxicity ...

8. biospace.com biospace.com/kangpu-biopharmaceuticals-initiates-phase-ib-iia-clinical-trial-of-kpg-818-in-systemic-lupus-erythematosus

Kangpu Biopharmaceuticals Initiates Phase Ib/IIa Clinical ... In the Phase I single ascending dose (SAD) clinical study recently completed in the U.S., KPG-818 was well tolerated at all tested dose levels ( ...