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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months of treatment
Awards & highlights
Study Summary
This trial is testing a new drug, KPG-818, to see if it is safe and effective in treating multiple myeloma, mantle cell lymphoma, diffuse large B-cell lymphoma, adult T-cell leukemia lymphoma, and other types of leukemia and lymphoma.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
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).
+12 moreOther outcome measures
Biomarkers of KPG-818
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
Find a Location
Who is running the clinical trial?
Kangpu Biopharmaceuticals, Ltd.Lead Sponsor
3 Previous Clinical Trials
120 Total Patients Enrolled
Kai Wei, MDStudy DirectorKangpu Biopharmacuticals
1 Previous Clinical Trials
64 Total Patients Enrolled
MDStudy DirectorKangpu Biopharmacuticals
913 Previous Clinical Trials
924,101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last year.I am 18 years old or older.I have been diagnosed with a specific type of blood or lymph node cancer.I have used immunosuppressive medication within the last 14 days.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with plasma cell leukemia.My condition hasn't improved with all known treatments, or I wasn't eligible for them.I have side effects from cancer treatment that are mild or better.I have had multiple treatments for my blood cancer and they haven't worked.I have not used strong CYP3A4/5 inhibitors, including grapefruit or St. John's Wort, in the last 2 weeks.My disease can be measured by specific tests or scans.I cannot or do not want to follow the required blood clot prevention treatment.I agree to use two forms of birth control during and for 3 months after the study.My disease can be measured or assessed by doctors.I haven't taken PD-1 or PD-L1 inhibitors in the last 3 months.I am currently pregnant, nursing, or breastfeeding.I haven't had major surgery or serious injuries in the last 6 weeks and don't plan any during the study.My cancer has returned or is not responding to treatment.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have unstable or poorly controlled chest pain.I have been diagnosed with congestive heart failure.I have a stomach or intestine condition that affects how my body absorbs medication.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I have active brain metastases or cancer in the lining of my brain.I have been cancer-free for over 5 years, except for MM, lymphoma, or CLL/SLL.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does KPG-818 pose a risk to patient health?
"A score of 1 was attributed to KPG-818 due it being a Phase 1 trial, and therefore having only limited data showing both its safety and effectiveness."
Answered by AI
What sites are currently hosting the trial?
"Nine medical centres across the US are currently hosting this study. Notable locations include Plantation, Sacramento and Durham. To minimise travelling requirements, it is suggested to choose a site that is close by if you decide to join in."
Answered by AI
What is the scope of participants in this medical experiment?
"The study demands that 30 compliant patients are enrolled in order to proceed. Participants can join from BRCR Global - USA situated in Plantation, Florida and UC Davis Comprehensive Cancer Center located in Sacramento, California."
Answered by AI
Are there any vacancies for individuals to participate in this research study?
"According to the clinicaltrials.gov website, this trial is currently enrolling participants and was initially posted on May 15th 2020. A recent update occurred on July 4th 2022."
Answered by AI
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