A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)

Conditions

• Metastatic Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MK-8294 — DRUG
  30 µg via intravenous (IV) infusion
• MK-8294 — DRUG
  100 µg via intravenous (IV) infusion
• MK-8294 — DRUG
  300 µg via intravenous (IV) infusion
• MK-8294 — DRUG
  1 mg via intravenous (IV) infusion
• MK-8294 — DRUG
  3 mg via intravenous (IV) infusion
• MK-8294 — DRUG
  10 mg via intravenous (IV) infusion
• MK-8294 — DRUG
  30 mg via intravenous (IV) infusion
• MK-8294 — DRUG
  70 mg via intravenous (IV) infusion
• CD8 PET Tracer — OTHER
  IV Infusion

Study Details

MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.

Key Dates

Start date

Jul 23, 2025

Status verified

Mar 2026

Primary completion

Aug 23, 2027

Completion

Aug 23, 2027

Study Design

Enrollment

67 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: MK-8294
  Participants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging.

Primary Outcome Measure

Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 35 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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