Health TrialsbyHealthPanel

Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.

ConditionRelapsed or Refractory AML and Other Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyowa Kirin Co., Ltd.

About this trial

This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill).

For patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies, in Part 1, the tolerability of KK2845 will be evaluated to determine the maximum tolerated dose (MTD). In Part 2, additional data will be collected by administering KK2845 at dose levels for which tolerability has been confirmed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a confirmed diagnosis of AML according to the WHO classification (2022 edition)by pathological examination at the performing institution conducted as screening test.

Patients who meet the following definition of relapsed or refractory.

Myeloblasts >5%

Blood blasts reappear in two peripheral blood samples at least one week apart

Disqualifiers

Patients who are diagnosed with APL.

Patients with suspected extramedullary disease.

Patients with a history of malignancy other than those listed in the inclusion criteria or with active malignancy other than those listed in the inclusion criteria (resected localized basal cell carcinoma and localized squamous cell carcinoma of the skin, resected noninvasive cervical cancer, resected noninvasive breast cancer, and cancers for which the last curative treatment was given more than 5 years ago are eligible for enrollment).

Patients with white blood cell count greater than 25000/mm3 (If treatment with hydroxyurea results in a white blood cell count of 25000/mm3 or less, enrollment in this study is acceptable) on screening test.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KK2845_1

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_2

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_3

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_4

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_5

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_6

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_7

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_8

    Drug

    KK2845 will be administered at several dose levels to determine maximum tolerated dose (MTD).

  • KK2845_alternative_1

    Drug

    KK2845 will be administered at several dose levels to collect additional data.

  • KK2845_alternative_2

    Drug

    KK2845 will be administered at several dose levels to collect additional data.

Treatment groups

156 Participants
are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Group A: KK2845 to R/R AML_1Experimental treatment 1 intervention
Group B: KK2845 to R/R AML_2Experimental treatment 1 intervention
Group C: KK2845 to R/R AML_3Experimental treatment 1 intervention
Group D: KK2845 to R/R AML_4Experimental treatment 1 intervention
Group E: KK2845 to R/R AML_5Experimental treatment 1 intervention
Group F: KK2845 to R/R AML_6Experimental treatment 1 intervention
Group G: KK2845 to R/R AML_7Experimental treatment 1 intervention
Group H: KK2845 to R/R AML_8Experimental treatment 1 intervention
Group I: KK2845 to R/R AML_alternative_1Experimental treatment 1 intervention
Group J: KK2845 to R/R AML_alternative_2Experimental treatment 1 intervention
Group K: KK2845 to other Hematologic Malignancies_1Experimental treatment 1 intervention
Group L: KK2845 to other Hematologic Malignancies_2Experimental treatment 1 intervention
Group M: KK2845 to other Hematologic Malignancies_3Experimental treatment 1 intervention
Group N: KK2845 to other Hematologic Malignancies_4Experimental treatment 1 intervention
Group O: KK2845 to other Hematologic Malignancies_5Experimental treatment 1 intervention
Group P: KK2845 to other Hematologic Malignancies_6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (Part 1：Dose escalation)

Time frame
At the end of Cycle 1 (each cycle is 21 or 28 days)

Secondary outcomes

1

Number of Adverse Events

Time frame
Through study completion, an average of 1 year
2

Blood Drug Concentration

Time frame
Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 21 or 28 days)
3

Number of ADA (anti-KK2845 antibody) positive Participants

Time frame
Through study completion, an average of 1 year
4

Best overall response (CR, CRh, CRi, MLFS, PR, Not evaluable, Relapsed disease, ORR)

Time frame
Pre-dose for Cycle 1 Day1, Each end of the cycles (each cycle is 21 or 28 days), Inspection at Discontinuation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyowa Kirin Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now