Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT06812104 | Recruiting Phase 1 DMC

• 1 other identifier: 2845-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 10

Brief Summary

This is the first in human study of KK2845. This trial consists of Part 1 (Dose escalation) and Part 2 (Backfill). In Part 1, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2845 in patients with relapsed or refractory acute myeloid leukemia. Part 2 will collect additional data at tolerated doses of KK2845.

Conditions

Relapsed or Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (Part 1：Dose escalation)

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (8)

• Number of Adverse Events

  Through study completion, an average of 1 year

• Blood Drug Concentration

  Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 21 days)

• Number of ADA (anti-KK2845 antibody) positive Participants

  Through study completion, an average of 1 year

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

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

• Duration of remission

  Through study completion, an average of 1 year

Study Arms (6)

KK2845_1

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_1

KK2845_2

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_2

KK2845_3

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_3

KK2845_4

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_4

KK2845_5

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_5

KK2845_6

EXPERIMENTAL

KK2845 will be administered at several dose levels to determine MTD.

Drug: KK2845_6

Interventions

KK2845_1 DRUG

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

KK2845_1

KK2845_2 DRUG

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

KK2845_2

KK2845_3 DRUG

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

KK2845_3

KK2845_4 DRUG

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

KK2845_4

KK2845_5 DRUG

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

KK2845_5

KK2845_6 DRUG

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

KK2845_6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given their free and voluntary written consent to participate in this clinical trial.
• Patients must be at least 18 years of age at the time consent is obtained.
• 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. Relapse: Patients with any of the following relapse findings after achieving CR, CRh, or CRi.
• Myeloblasts \>5%
• Blood blasts reappear in two peripheral blood samples at least one week apart Refractory: Patients who have failed to achieve CR, CRh, or CRi after a sufficient duration of initial intensive chemotherapy or initial treatment with venetoclax or hypomethylating agents.
• Patients who are considered to have no standard treatment with sustained remission, who have failed to complete a potentially curative treatment, who have no treatment with a promising therapeutic effect, or who have refused standard treatment.
• Patients with an ECOG PS of 0 to 2 on screening test.
• Patients with hematopoietic, hepatic, renal, and cardiac function that meet all of the following criteria on screening test.
• Hematopoietic capacity
• Neutrophil count greater than 500/mm3 However, even if the neutrophil count is less than 500/mm3, if the principal investigator or sub investigator judges that the neutrophil count is expected to improve, enrollment in this study is acceptable.
• Liver function
• AST within 3.0 times the upper reference limit
• ALT within 3.0 times the upper reference limit
• T-Bil within 1.5 times the upper limit of the standard

You may not qualify if:

• Patients who are diagnosed with APML.
• Patients suspected extramedullary disease.
• 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.
• Patients who underwent a previous allogeneic hematopoietic stem cell transplant.
• However, enrollment in this trial is permitted if all of the following criteria are met:
• At least 6 months have elapsed since allogeneic hematopoietic stem cell transplantation as of Cycle 1 Day 1.
• The patient does not have active acute GvHD of Grade 2 or higher, nor active chronic GvHD of any severity. Acute GvHD is classified according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD is classified according to the NIH criteria (Jagasia et al., 2015), by Grade or severity. Acute GvHD should be graded according to the MAGIC criteria (Harris et al., 2016), and chronic GvHD according to the NIH criteria (Jagasia et al., 2015).
• At least 4 weeks have elapsed since the donor lymphocyte infusion at Cycle 1 Day 1.
• Patients who have received anti-tumor therapy such as anticancer agents or radiotherapy (except for patients taking hormone therapy as adjuvant maintenance therapy for breast or prostate cancer prior to the start of study treatment) within the following time periods prior to Cycle 1 Day 1.
• anticancer agents: 2 weeks (If hydroxyurea is used to control blasts, registration is acceptable for use up to Day -1)
• Hormone therapy: 2 weeks
• Radiation therapy: 4 weeks
• Unapproved medical devices: 4 weeks
• Patients who received another investigational drug within 4 weeks or 5 times the half-life prior to Cycle 1 Day 1, whichever is shorter.
• Patients who underwent major surgery (excluding biopsy, central venous catheter insertion, and tooth extractions, etc.) within 4 weeks prior to Cycle 1 Day 1.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (10)

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, 920-8641, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Kindai University Hospital

Osaka, 589-8511, Japan

RECRUITING

Saitama Medical University Hospital

Saitama, 350-0495, Japan

RECRUITING

Toranomon Hospital

Tokyo, 105-8470, Japan

RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

RECRUITING

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kyowa Kirin Co., Ltd.

  Kyowa Kirin Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Masayoshi Noshiro

CONTACT

+81-90-2488-4889; masayoshi.noshiro.kj@kyowakirin.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: February 6, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)