KPG-818 for Blood Cancers

Recruiting at 7 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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

MD

Principal Investigator

Kangpu Biopharmacuticals

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+