A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)

Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Myeloid Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Chronic Myeloid Leukemia, Chronic Phase

Treatments: Drug: MK-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT06163430

2023-507677-18-00 (EU Trial (CTIS) Number)

MK-4208-003 (Other Identifier)

CARDINAL (Other Identifier)

2023

4208-003

Tern701-1012 (Other Identifier)

Details and patient eligibility

About

Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer.

The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 Leukemia (CML) in Chronic Phase
• Have received treatment with at least one prior tyrosine kinase inhibitor (TKI) and have treatment failure, suboptimal response, or treatment intolerance
• Prior treatment with asciminib is allowed
• Adequate organ function, as assessed by local laboratory

Key Exclusion Criteria:

Exclusion criteria include but are not limited to:

• Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of MK-4208/TERN-701
• Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 10 patient groups

Part 1 - MK-4208 160 mg once daily (QD)

Experimental group

Description:

Participants receive MK-4208 160 mg orally QD.

Treatment:

Drug: MK-4208

Part 1- MK-4208 320 mg QD

Experimental group

Description:

Participants receive MK-4208 320 mg orally QD.

Treatment:

Drug: MK-4208

Part 1- MK-4208 400 mg QD

Experimental group

Description:

Participants receive MK-4208 400 mg orally QD.

Treatment:

Drug: MK-4208

Part 1- MK-4208 500 mg QD

Experimental group

Description:

Participants receive MK-4208 500 mg orally QD.

Treatment:

Drug: MK-4208

Part 2 - MK-4208 320 mg QD

Experimental group

Description:

Participants receive MK4208 320 mg orally QD.

Treatment:

Drug: MK-4208

Part 2 - MK-4208 500 mg QD

Experimental group

Description:

Participants receive MK4208 500 mg orally QD.

Treatment:

Drug: MK-4208

Part 2m - MK-4208 320 mg twice per day (BID)

Experimental group

Description:

Participants receive MK4208 320 mg orally BID.

Treatment:

Drug: MK-4208

Part 2m - MK-4208 500 mg QD

Experimental group

Description:

Participants receive MK-4208 500 mg orally QD.

Treatment:

Drug: MK-4208

Part 2m - MK4208 500 mg BID

Experimental group

Description:

Participants receive MK4208 500 mg orally BID.

Treatment:

Drug: MK-4208

Part 3 - MK-4208 500 mg QD

Experimental group

Description:

Participants receive MK-4208 500 mg QD

Treatment:

Drug: MK-4208