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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    30
  • sponsor
    Kangpu Biopharmaceuticals, Ltd.
Updated on 21 July 2022
cancer
corticosteroids
calcium
immunosuppressant
lymphoid leukemia
chronic lymphocytic leukemia
lymphoma
bone marrow transplant
multiple myeloma
measurable disease
leukemia
dexamethasone
experimental drug
progressive disease
neutrophil count
mantle cell lymphoma
t-all

Summary

This is a Phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, PK, and preliminary clinical activity of KPG-818 in combination with dexamethasone in adult subjects with multiple myeloma (MM), and KPG-818 as monotherapy in subjects with other selected hematological malignancies, including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), adult T-cell leukemia lymphoma (ATL), indolent lymphoma, such as follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), etc.

This study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in subjects with selected hematological malignancies.

Description

This is a Phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, PK, and preliminary clinical activity of KPG-818 in combination with dexamethasone in adult subjects with multiple myeloma (MM), and KPG-818 as monotherapy in subjects with other selected hematological malignancies, including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), adult T-cell leukemia lymphoma (ATL), indolent lymphoma, such as follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), etc.

This will be a dose escalation study in subjects with selected hematological malignancies. All study center(s) will be in the US.

After providing informed consent, subjects will be assessed for study eligibility at the Screening visit (Days -28 to -1). Cohorts of 1 to 6 subjects per dose level will be given escalating doses of KPG-818 during each 28-day cycle orally until progressive disease (PD), unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met. The 4 planned dose escalation cohorts will be 5, 10, 20, and 30 mg. The highest does level which may be tested is 30mg. If there are safety concerns, dose level or dosing schedule may be modified and recommended by SRC.

Dose escalation will use an accelerated titration design (ATD) where the first dose level will include one subject. Subsequent dose levels will use a 3+3 approach to establish a MTD. The first subject will receive the initial escalation dose level 5 mg/day and be dosed according to specific dosing schedule over a 28-day treatment cycle, and in the absence of a DLT or Grade 2 or greater study drug-related AE and after review of the data from the first full cycle by the Safety Review Committee (SRC), the next 3 subjects will receive 10 mg/day followed by review of the data by the SRC. Once 10 mg/day is reached, the enrolment will revert to a standard 3+3 escalation design.

If 1 or more Grade 2 or greater study drug-related AE is observed at dose level 5 mg/day, two additional subjects will be enrolled at the same dose level, and dose escalation reverts to a standard 3+3 escalation design. If 1 or more DLT is observed at dose level 5 mg/day, five additional subjects will be enrolled at the same dose level and dose escalation reverts to a standard 3+3 escalation design . Enrolment to 10 mg/day will follow a standard 3+3 escalation design.

Dose-limiting toxicity (DLT) will be assessed during the 28-day DLT evaluation period. Non-DLT evaluable subjects who exit the study for reasons other than DLT prior to completion of the 28-day evaluation period with a drug exposure of at least 80% of the planned doses will be replaced to ensure an adequate safety assessment at each dose.

The Safety Review Committee (SRC), will be responsible for dose escalation decisions, including whether to modify the dose escalation based on the DLT observations or determine RP2D. Escalation to the Maximal Tolerated Dose (MTD) is not appropriate if activity plateaus at a lower dose.

Details
Condition Hematological Malignancies
Treatment KPG-818
Clinical Study IdentifierNCT04283097
SponsorKangpu Biopharmaceuticals, Ltd.
Last Modified on21 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note