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Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects

Primary Purpose

Hematological Malignancies

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KPG-818
Sponsored by
Kangpu Biopharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Willing and able to provide written consent.
  3. Willing and able to adhere to the study visit schedule and other protocol requirements.
  4. Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.
  5. Subjects who have relapsed from or are refractory to ALL FDA approved therapies* known to provide clinical benefit for the specific disease, unless the subject is not eligible for the approved therapy.

    *Definition of ALL FDA approved therapies are specified as below:

    Prior treatments for MM subjects:

    • Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and an anti-CD38 antibody (induction with or without a bone marrow transplant with or without maintenance therapy is considered one regimen).
    • Refractory disease defined as disease that is nonresponsive to therapy (failure to achieve minimal response or development of progressive disease) or disease progression within 60 days from the last dose of their last myeloma therapy.

    Prior treatments for NHL subjects:

    • ATL: at least 2 prior lines of therapy containing alkylator-based chemotherapy.
    • MCL: at least 2 prior lines of therapy, including CD20 antibody and alkylator chemotherapy, and a Bruton's tyrosine kinase (BTK) inhibitor.
    • DLBCL: at least 2 prior lines of therapy, including prior CD20 antibody therapy, and has received prior autologous bone marrow transplant (or is ineligible for bone marrow transplant).
    • FL: at least 2 prior lines of therapy, including CD20 antibody therapy and alkylator chemotherapy.
    • CLL/SLL: at least 2 prior lines of therapy for CLL/SLL and require treatment by 2018 iwCLL criteria.
    • Other indolent NHL: Subjects must have been treated with all standard of care therapies available to the subject which, in the assessment of the investigator, may be beneficial to the subject.
  6. Have measurable or assessable disease.

    For MM:

    • M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (SPEP or SIFE) or
    • M-protein quantities ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (UPEP or UIFE) or
    • Serum free light chain (FLC) levels > 100 mg/L involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without detectable serum or urine M-protein or
    • For subjects with immunoglobulin (Ig) class A (IgA) myeloma whose disease can only be reliably measured by quantitative Ig measurement, a serum IgA level ≥ 0.50 g/dL.

    For MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.:

    • At least 1 bidimensionally measurable lesion larger than 1.5 cm in largest dimension by computed tomography (CT), positron emission tomography CT (PET-CT), or magnetic resonance imaging (MRI) scan.

  7. Meet following laboratory requirements:

    • Absolute neutrophil count ≥ 1.0 × 109/L (Granulocyte-colony stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF] allowed if received within 2 weeks prior to screening parameter).
    • Hemoglobin > 7.5 g/dL (red blood cell [RBC] transfusion is allowed to meet eligibility if performed more than 7 days prior to screening parameter).
    • Platelet count > 75 000/μL (platelet transfusions are allowed if received more than 2 weeks prior to screening parameter)
    • Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).
    • AST and/or ALT < 2.5 × ULN or < 5.0 × ULN if liver tumor is present.
    • Total serum bilirubin ≤ 1.5 × ULN.
    • Estimated serum creatinine clearance of > 60 mL/min that does not require dialysis; estimated serum creatinine clearance between 50-60 mL/min may be enrolled for KPG-818 dose ≤ 10mg/day. For subjects with serum creatinine clearance between 50-60 mL/min at screening, serum creatinine clearance levels should be monitored during the study.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. In case of ECOG 2, the Investigator can discuss with Sponsor before making eligibility decision.
  9. Males and females of childbearing potential must agree to use at least two methods of contraception, as detailed in Section 6.1.3, during the study treatment and continue until 3 months after the completion of study treatment.

4.2. Exclusion Criteria

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

  1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Currently enrolled in another clinical study, except observational studies.
  3. Has known active central nervous system metastases and/or lymphomatous meningitis.
  4. Persisting toxicities related to prior anticancer treatment > Grade 1 according to NCI CTCAE v5.0.
  5. Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
  6. Received live attenuated vaccine within 4 weeks of first dose.
  7. Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug.
  8. Subjects with a plasma cell leukemia.
  9. 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 with the exception of the following noninvasive malignancies:

    • Basal cell carcinoma of the skin.
    • Squamous cell carcinoma of the skin.
    • Carcinoma in situ.
    • Incidental histological findings of prostate cancer such as T1a or T1b using the tumor/node/metastasis classification of malignant tumors or prostate cancer that is curative.
  10. Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
  11. Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP).
  12. Has received any of the following within the last 14 days of initiating IP:

    • Plasmapheresis
    • Radiation therapy other than local therapy for MM associated bone lesions
    • Use of any systemic myeloma/lymphoma/CLL/SLL drug therapy.
  13. Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP.
  14. Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP.
  15. Has any one of the following:

    • Clinically significant abnormal ECG finding, including QTcF interval elongation (> 480 ms), at Screening.
    • Congestive heart failure (New York Heart Association Class III or IV).
    • 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.
  16. Has current or prior use of immunosuppressive medication within 14 days prior initiating IP. The following are exceptions to this criterion:

    • Intranasal, inhaled, topical, or local steroid injections (e.g., intra-articular injection)
    • Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or equivalent
    • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  17. Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C.

    Note: subjects who are hepatitis B core antibody (anti-HBc) positive and hepatitis B surface antigen (HBsAg) negative are required to have a negative hepatitis B DNA PCR result before randomization and must be willing to undergo the DNA PCR testing during the study. Subjects who are HBsAg positive or hepatitis B DNA PCR positive will be excluded.

    Subjects who are hepatitis C virus antibody positive are required to have a negative hepatitis C RNA PCR result. Subjects who are hepatitis C RNA PCR-positive will be excluded.

  18. Subjects with any active and uncontrolled infection.
  19. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
  20. Subject is a female who is pregnant, nursing, or breastfeeding.

Sites / Locations

  • UC Davis Comprehensive Cancer CenterRecruiting
  • BRCR Global - USARecruiting
  • Norton Cancer Institute
  • Henry Ford Health System - Hemophilia and Thrombosis Treatment CenterRecruiting
  • Mohamad Medical CherryRecruiting
  • Duke University Health System - Duke Endoscopy - Duke Clinic 2HRecruiting
  • Providence Portland Medical Center
  • UPMC CancerCenterRecruiting
  • Laguna Clinical Research AssociatesRecruiting
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

KPG-818 dose escalation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

PK profile of KPG-818: maximum observed plasma concentration (Cmax).
PK profile of KPG-818: time of the maximum observed plasma concentration (Tmax)
PK profile of KPG-818: area under the plasma concentration-time profile (AUC) from time zero to the last quantifiable concentration (AUC0-t).
PK profile of KPG-818: AUC from time zero extrapolated to infinity (AUC0-∞).
PK profile of KPG-818: AUC within a dosing interval (AUC0-τ).
PK profile of KPG-818: apparent total plasma clearance (CL/F).
PK profile of KPG-818: apparent total plasma clearance at steady-state (CLss/F).
PK profile of KPG-818: apparent volume of distribution (Vz/F)
PK profile of KPG-818: apparent volume of distribution at steady-state (Vss).
PK profile of KPG-818: apparent plasma terminal elimination. half-life (t1/2)
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).
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).
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).
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).
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).

Full Information

First Posted
February 21, 2020
Last Updated
April 14, 2023
Sponsor
Kangpu Biopharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04283097
Brief Title
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
January 19, 2024 (Anticipated)
Study Completion Date
May 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kangpu Biopharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Masking Description
This is a open label Phase I study
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
KPG-818 dose escalation
Intervention Type
Drug
Intervention Name(s)
KPG-818
Other Intervention Name(s)
KPG-818 capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
Up to 6 months of treatment
Title
Recommended Phase 2 Dose (RP2D)
Description
Maximum tolerated dose defined as the highest dose level at which 33% or less subjects experience DLT as defined by the protocol.
Time Frame
Up to 4 weeks of treatment
Secondary Outcome Measure Information:
Title
PK profile of KPG-818: maximum observed plasma concentration (Cmax).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: time of the maximum observed plasma concentration (Tmax)
Time Frame
Up to 4 weeks of treatment
Title
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
Title
PK profile of KPG-818: AUC from time zero extrapolated to infinity (AUC0-∞).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: AUC within a dosing interval (AUC0-τ).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: apparent total plasma clearance (CL/F).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: apparent total plasma clearance at steady-state (CLss/F).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: apparent volume of distribution (Vz/F)
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: apparent volume of distribution at steady-state (Vss).
Time Frame
Up to 4 weeks of treatment
Title
PK profile of KPG-818: apparent plasma terminal elimination. half-life (t1/2)
Time Frame
Up to 4 weeks of treatment
Title
Assessment of clinical activity: objective response rate (ORR).
Description
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).
Time Frame
Up to 6 months of treatment
Title
Assessment of clinical activity: disease control rate (DCR).
Description
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).
Time Frame
Up to 6 months of treatment
Title
Assessment of clinical activity: time to response, duration of response.
Description
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).
Time Frame
Up to 6 months of treatment
Title
Assessment of clinical activity: progression-free survival.
Description
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).
Time Frame
Up to 6 months of treatment
Title
Assessment of clinical activity: event-free survival (EFS), and transplantation rate (TR).
Description
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).
Time Frame
Up to 6 months of treatment
Other Pre-specified Outcome Measures:
Title
Biomarkers of KPG-818
Description
Aiolos and Ikaros in peripheral blood mononuclear cell (PBMC)
Time Frame
Up to 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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. 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Wang, MD
Phone
+19738738678
Email
yao.wang@kangpugroup.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wei, MD
Phone
+8618201496205
Email
kai.wei@kangpugroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Kangpu Biopharmacuticals
Official's Role
Study Director
Facility Information:
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Rosenberg
Facility Name
BRCR Global - USA
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harshad Amin
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Completed
Facility Name
Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Mattour
Facility Name
Mohamad Medical Cherry
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad M Cherry
Facility Name
Duke University Health System - Duke Endoscopy - Duke Clinic 2H
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiana Costa Chase
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Completed
Facility Name
UPMC CancerCenter
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Zhou Hou
Facility Name
Laguna Clinical Research Associates
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Miranda
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0509
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects

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