Hematological MalignanciesPhase 1NCT04283097
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
A Phase 1 study testing KPG-818 in people with Hematological Malignancies, run by Kangpu Biopharmaceuticals, Ltd. at 10 sites in United States.
Trial summary
This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- KPG-818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Sep 2021to 12 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Willing and able to provide written consent.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.
- Subjects who have relapsed from or are refractory to MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL.
- Have measurable or assessable disease.
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- Meet the laboratory requirements:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Males and females of childbearing potential must agree to use at least two methods of contraception and continue until 3 months after the completion of study treatment.
Who cannot join
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Currently enrolled in another clinical study, except observational studies.
- Has known active central nervous system metastases and/or lymphomatous meningitis.
- Persisting toxicities related to prior anticancer treatment > Grade 1.
- Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
- Received live attenuated vaccine within 4 weeks of first dose.
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- Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug.
- Subjects with a plasma cell leukemia.
- Subjects with prior history of malignancies, other than MM, lymphoma, or CLL/SLL, unless the subject has been free of the disease for ≥ 5 years.
- Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
- Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP).
- Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days of initiating IP.
- Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP.
- Has any one of the following:
- Clinically significant abnormal ECG finding at Screening.
- Congestive heart failure.
- Myocardial infarction within 12 months prior to initiating IP.
- Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
- Peripheral neuropathy ≥ Grade 2.
- Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within 2 weeks prior to dosing and during the course of study.
- Has current or prior use of immunosuppressive medication within 14 days prior initiating IP.
- Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C.
- Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
- Subject is a female who is pregnant, nursing, or breastfeeding.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
Detroit, Michigan, 48202-2689
Duke University Health System - Duke Endoscopy - Duke Clinic 2H
Durham, North Carolina, 27710-4000
Laguna Clinical Research Associates
Laredo, Texas, 78041
Norton Cancer Institute
Louisville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-0509
Mohamad Medical Cherry
Morristown, New Jersey, 07960
UPMC CancerCenter
Pittsburgh, Pennsylvania, 15232
BRCR Global - USA
Plantation, Florida, 33322
Providence Portland Medical Center
Portland, Oregon, 97213
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase 1, Multicenter, Open-label, Multiple-ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of KPG-818 in Subjects With Hematological Malignancies
This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels.
Indication: Hematological malignancies (multiple myeloma [MM], mantle cell lymphoma [MCL], diffuse large B-cell lymphoma [DLBCL], adult T-cell leukemia-lymphoma [ATL], and indolent non Hodgkin lymphomas such as follicular lymphoma [FL] and chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL]).
Read the detailed description
This will be a dose escalation study in subjects with selected hematological malignancies. 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-818 will be administered orally until the completion of treatment cycles, or progressive disease (PD), unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met.
The highest dose level which may be tested is 5 mg KPG-818 and dose levels 2, 3, 4, and 5 mg and/or intermediate dosing or alternative dosing schedule may be explored. Each dose level (1-4) will be tested using the standard 3+3 design. DLT will be assessed during the DLT evaluation period (Cycle 1) and the treatment of study is divided into 6 cycles.
- Conditions
- Hematological Malignancies
- Being tested
- KPG-818
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPG-818Drug
Also called KPG-818 capsules
The 4 planned dose level (cohorts) of KPG-818 will be explored: 2, 3, 4 and 5mg. Each dose of KPG-818 will be administered orally with approximately 240 ml of water daily, and used as a single agent in subjects with selected hematological malignancies (or in combination with dexamethasone weekly for MM), according to specific dosing schedule in each treatment cycle until disease progression, unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met. The treatment of study is divided into 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | KPG-818 dose escalation Receives: Drug: KPG-818 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Treatment-Emergent Adverse Events(TEAE), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and changes from baseline in laboratory parameters, vital signs, and ECG.
Measured: Up to 6 months of treatment
Recommended Phase 2 Dose (RP2D)
Maximum tolerated dose defined as the highest dose level at which 33% or less subjects experience DLT as defined by the protocol.
Measured: Up to 4 weeks of treatment
Secondary outcomes (15)
PK profile of KPG-818: maximum observed plasma concentration (Cmax).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: time of the maximum observed plasma concentration (Tmax)
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: area under the plasma concentration-time profile (AUC) from time zero to the last quantifiable concentration (AUC0-t).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: AUC from time zero extrapolated to infinity (AUC0-∞).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: AUC within a dosing interval (AUC0-τ).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: apparent total plasma clearance (CL/F).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: apparent total plasma clearance at steady-state (CLss/F).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: apparent volume of distribution (Vz/F)
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: apparent volume of distribution at steady-state (Vss).
Measured: Up to 4 weeks of treatment
PK profile of KPG-818: apparent plasma terminal elimination. half-life (t1/2)
Measured: Up to 4 weeks of treatment
Assessment of clinical activity: objective response rate (ORR).
Responses are evaluated based on International Myeloma Working Group (IMWG) Uniform Response Criteria (for MM), Lugano Classification (for lymphoma), International Workshop Group on CLL (iwCLL) Response Criteria, and according to the 'Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma' (for ATL).
Measured: Up to 6 months of treatment
Assessment of clinical activity: disease control rate (DCR).
Responses are evaluated based on International Myeloma Working Group (IMWG) Uniform Response Criteria (for MM), Lugano Classification (for lymphoma), International Workshop Group on CLL (iwCLL) Response Criteria, and according to the 'Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma' (for ATL).
Measured: Up to 6 months of treatment
Assessment of clinical activity: time to response, duration of response.
Responses are evaluated based on International Myeloma Working Group (IMWG) Uniform Response Criteria (for MM), Lugano Classification (for lymphoma), International Workshop Group on CLL (iwCLL) Response Criteria, and according to the 'Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma' (for ATL).
Measured: Up to 6 months of treatment
Assessment of clinical activity: progression-free survival.
Responses are evaluated based on International Myeloma Working Group (IMWG) Uniform Response Criteria (for MM), Lugano Classification (for lymphoma), International Workshop Group on CLL (iwCLL) Response Criteria, and according to the 'Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma' (for ATL).
Measured: Up to 6 months of treatment
Assessment of clinical activity: event-free survival (EFS), and transplantation rate (TR).
Responses are evaluated based on International Myeloma Working Group (IMWG) Uniform Response Criteria (for MM), Lugano Classification (for lymphoma), International Workshop Group on CLL (iwCLL) Response Criteria, and according to the 'Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma' (for ATL).
Measured: Up to 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start13 Sep 2021
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation will use a standard 3+3 approach to establish a maximum tolerated dose (MTD), and the initial escalation dose level will be 2mg/day. Subjects may be enrolled at dose levels 2, 3, 4, and 5 mg and/or intermediate dosing or alternative dosing schedule
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Kangpu Biopharmacuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283097
- Sponsor's protocol ID
- KPG-818-HEM-101
- Status last verified
- May 2025
- First submitted
- 21 Feb 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Multiple-ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of KPG-818 in Subjects With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04283097
- Acronym / sponsor ID
- KPG-818-HEM-101
- Conditions
- Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kangpu Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels.
Indication: Hematological malignancies (multiple myeloma [MM], mantle cell lymphoma [MCL], diffuse large B-cell lymphoma [DLBCL], adult T-cell leukemia-lymphoma [ATL], and indolent non Hodgkin lymphomas such as follicular lymphoma [FL] and chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL]).
Detailed description
This will be a dose escalation study in subjects with selected hematological malignancies. 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-818 will be administered orally until the completion of treatment cycles, or progressive disease (PD), unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met.
The highest dose level which may be tested is 5 mg KPG-818 and dose levels 2, 3, 4, and 5 mg and/or intermediate dosing or alternative dosing schedule may be explored. Each dose level (1-4) will be tested using the standard 3+3 design. DLT will be assessed during the DLT evaluation period (Cycle 1) and the treatment of study is divided into 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation will use a standard 3+3 approach to establish a maximum tolerated dose (MTD), and the initial escalation dose level will be 2mg/day. Subjects may be enrolled at dose levels 2, 3, 4, and 5 mg and/or intermediate dosing or alternative dosing schedule
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: KPG-818KPG-818 dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years of age
- Willing and able to provide written consent.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.
- Subjects who have relapsed from or are refractory to MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL.
Key exclusion criteria (24 listed)
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Currently enrolled in another clinical study, except observational studies.
- Has known active central nervous system metastases and/or lymphomatous meningitis.
- Persisting toxicities related to prior anticancer treatment > Grade 1.
- Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPG-818Also: KPG-818 capsulesThe 4 planned dose level (cohorts) of KPG-818 will be explored: 2, 3, 4 and 5mg. Each dose of KPG-818 will be administered orally with approximately 240 ml of water daily, and used as a single agent in subjects with selected hematological malignancies (or in combination with dexamethasone weekly for MM), according to specific dosing schedule in each treatment cycle until disease progression, unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met. The treatment of study is divided into 6 cycles. | Drug | Single arm |
Primary outcome
Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 6 months of treatment
Number of Treatment-Emergent Adverse Events(TEAE), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and changes from baseline in laboratory parameters, vital signs, and ECG.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 4 weeks of treatment
Maximum tolerated dose defined as the highest dose level at which 33% or less subjects experience DLT as defined by the protocol.
15 secondary outcomes
PK profile of KPG-818: maximum observed plasma concentration (Cmax).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: time of the maximum observed plasma concentration (Tmax)
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: area under the plasma concentration-time profile (AUC) from time zero to the last quantifiable concentration (AUC0-t).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: AUC from time zero extrapolated to infinity (AUC0-∞).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: AUC within a dosing interval (AUC0-τ).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: apparent total plasma clearance (CL/F).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: apparent total plasma clearance at steady-state (CLss/F).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: apparent volume of distribution (Vz/F)
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: apparent volume of distribution at steady-state (Vss).
Time frame: Up to 4 weeks of treatment
PK profile of KPG-818: apparent plasma terminal elimination. half-life (t1/2)
Time frame: Up to 4 weeks of treatment
Assessment of clinical activity: objective response rate (ORR).
Time frame: Up to 6 months of treatment
Assessment of clinical activity: disease control rate (DCR).
Time frame: Up to 6 months of treatment
Assessment of clinical activity: time to response, duration of response.
Time frame: Up to 6 months of treatment
Assessment of clinical activity: progression-free survival.
Time frame: Up to 6 months of treatment
Assessment of clinical activity: event-free survival (EFS), and transplantation rate (TR).
Time frame: Up to 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Kangpu Biopharmacuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KPG-818 in people with Hematological Malignancies, run by Kangpu Biopharmaceuticals, Ltd. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 6 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.