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MK-4208

Phase 1

Leukemia, Myelogenous, Chronic, BCR-ABL Positive | Small molecule | Oncology |Terns Pharmaceuticals, Inc.|Trials Updated: Oct 15, 2026

MK-4208 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2023

MK-4208 target and mechanism

ModalitySmall molecule

Also known as Tern-701, HS-10382

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

MK-4208 clinical trials

MK-4208 · 1 trial · 3 indications

Phase 1 1
NCT06163430A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)Leukemia, Myelogenous, Chronic, BCR-ABL Positive
RECRUITING330 Analytics
PHASE1RECRUITING
A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)
Leukemia, Myelogenous, Chronic, BCR-ABL PositiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Incidence of Dose Limiting Toxicities (DLTs) During the First Cycle of Intervention
Up to 28 days

A DLT is any of a prespecified list of adverse events (AEs) of a pre-specified severity that occur during Cycle 1 (up to 28 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 28 days.

Parts 1, 2m and 3: Number of Participants with at Least One AE
Up to 3 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding that is determined to be clinically significant by the investigator), symptom, or disease (new or exacerbated) temporally associated with the use of trial intervention. The number of participants with at least one AE will be reported.

Parts 1, 2m and 3: Number of Participants with at Least One Serious Adverse Event (SAE)
Up to 3 years

An SAE is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Other situations determined to be SAEs by the investigator. The number of participants with at least one SAE will be reported.

Parts 1, 2m and 3: Number of Participants who Discontinued Study Intervention Due to an AE
Up to 3 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding that is determined to be clinically significant by the investigator), symptom, or disease (new or exacerbated) temporally associated with the use of trial intervention. The number of participants who discontinued study intervention due to an AE will be reported.

Parts 2, 2m and 3: Number of Participants with a Complete Hematologic Response (CHR)
Baseline and up to 3 years

The hematologic response will be evaluated by hematology and differential blood count. A CHR is defined by meeting all the following criteria and lasting for at least 4 weeks: Peripheral blood white blood cell count \< 10 × 109/L ; Peripheral blood platelet count \< 450 × 109/L; No immature cells in peripheral blood, such as myelocytes, promyelocytes, blasts and immature cells, and a basophil level \< 5%; No symptoms or signs of the disease under trial, and the palpable splenomegaly has disappeared. The number of participants with a CHR will be reported.

Parts 2, 2m and 3: Number of Participants with a Molecular response (MR)
Baseline and up to 3 years

The MR will be evaluated for all participants, and peripheral blood will be collected and tested for breakpoint cluster region::Abelson (BCR::ABL1/ABLIS) using real-time quantitative polymerase chain reaction performed locally and centrally with validated polymerase chain reaction technology that has a sensitivity of at least 4.5 logs. An MR is defined as follows: MR1: BCR::ABL1IS \> 1% to 10%; MR2: BCR::ABL1IS \> 0.1% to 1%; MR3 (MMR): BCR::ABL1IS \> 0.01% to 0.1%; MR4.0: BCR::ABL1IS \> 0.0032% to 0.01%; MR4.5: BCR::ABL1IS \> 0.001% to 0.0032%, MR5: ≤ 0.001%. The number of participants with a MR will be reported.

Parts 2, 2m and 3: Number of Participants who had Best Categorical Shift in BCR-ABL1 Transcript Levels From Baseline
Baseline and up to 3 years

The number of participants who had best categorical molecular response shift on treatment relative to baseline will be reported.

Secondary Endpoints

Parts 1, 2, 2m and 3: Trough Concentration (Ctrough) of MK-4208 in Plasma
Pre dose and post dose at predetermined time points up to 3 years
Parts 1, 2, 2m and 3: Maximum Concentration (Cmax) of MK-4208 in Plasma
Pre dose and post dose at predetermined time points up to 3 years
Parts 1, 2, 2m and 3: Area Under the Plasma Concentration Time Curve (AUC) of MK-4208 in Plasma
Pre dose and post dose at predetermined time points up to 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - MK-4208 160 mg once daily (QD)EXPERIMENTALParticipants receive MK-4208 160 mg orally QD.
Part 1- MK-4208 320 mg QDEXPERIMENTALParticipants receive MK-4208 320 mg orally QD.
Part 1- MK-4208 400 mg QDEXPERIMENTALParticipants receive MK-4208 400 mg orally QD.
Part 1- MK-4208 500 mg QDEXPERIMENTALParticipants receive MK-4208 500 mg orally QD.
Part 2 - MK-4208 320 mg QDEXPERIMENTALParticipants receive MK4208 320 mg orally QD.
Part 2 - MK-4208 500 mg QDEXPERIMENTALParticipants receive MK4208 500 mg orally QD.
Part 2m - MK-4208 320 mg twice per day (BID)EXPERIMENTALParticipants receive MK4208 320 mg orally BID.
Part 2m - MK-4208 500 mg QDEXPERIMENTALParticipants receive MK-4208 500 mg orally QD.
Part 2m - MK4208 500 mg BIDEXPERIMENTALParticipants receive MK4208 500 mg orally BID.
Part 3 - MK-4208 500 mg QDEXPERIMENTALParticipants receive MK-4208 500 mg QD

Interventions

NameTypeDescription
MK-4208DRUG40 mg and 100 mg oral tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Key Inclusion Criteria: Inclusion Criteria include but are not limited to: * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Have an established cytopathologically confirmed diagnosis of breakpoint cluster region::Abelson (BCR-ABL1) positive Chronic Myeloid L...

Countries:United StatesAustraliaFranceGermanyItalyNew ZealandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMOct 30, 2026NCT06163430Enrollment: 180 → 330
MEDIUMOct 30, 2026NCT06163430Enrollment: 180 → 330
MEDIUMOct 30, 2026NCT06163430Enrollment: 180 → 330