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OncoMatch/Clinical Trials/NCT06812104

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

Is NCT06812104 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for relapsed or refractory aml and other hematologic malignancies.

Phase 1RecruitingKyowa Kirin Co., Ltd.NCT06812104Data as of Sep 2026Location: Japan

Treatment: KK2845_1 · KK2845_2 · KK2845_3 · KK2845_4 · KK2845_5 · KK2845_6 · KK2845_7 · KK2845_8 · KK2845_alternative_1 · KK2845_alternative_2This 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.

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Extracted eligibility criteria

Treatments studied

Other

KK2845_1KK2845_2KK2845_3KK2845_4KK2845_5KK2845_6KK2845_7KK2845_8KK2845_alternative_1KK2845_alternative_2

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: allogeneic hematopoietic stem cell transplant

Exception: allowed if ≥6 months since transplant, no active acute gvhd grade 2+ or active chronic gvhd, and ≥4 weeks since donor lymphocyte infusion

Lab requirements

Blood counts

neutrophil count >500/mm3 (may enroll if expected to improve per investigator)

Kidney function

creatinine clearance ≥50 ml/min (cockcroft-gault); if 30–49 ml/min and serum creatinine ≤1.5x uln, enrollment permitted

Liver function

ast/alt within 3.0x upper reference limit; t-bil within 1.5x upper limit of standard

Cardiac function

lvef ≥50% (muga or echo); qtcf <450 msec (males), <480 msec (females)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06812104 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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