In short
MK-1045 is an investigational protein-based substance with no marketing authorisation, meaning it is not yet approved as a medicine. It is being studied as an intravenous infusion in three authorised clinical trials covering non-Hodgkin lymphoma, follicular lymphoma, and relapsed/refractory B-cell acute lymphoblastic leukaemia. The trials range from Phase 1 to Phase 4 and involve between 52 and 349 participants.
MK-1045 is a protein-based substance being developed as a potential treatment for certain blood cancers. It is classified under the therapeutic area of neoplasms, which means cancers and related conditions. The substance is given as a solution for infusion, mainly by intravenous infusion, and is supplied by Merck & Co. Inc. In the product records of the three trials described here, MK-1045 has no marketing authorisation, so it remains an investigational substance.
MK-1045 is the only name for this substance in the registry records. It appears as the test substance in all three trials, meaning it is the main medicine being investigated, not a comparison or placebo.
Key points
- MK-1045 is an investigational protein-based substance given by intravenous infusion.
- It is being tested in three authorised trials for blood cancers: non-Hodgkin lymphoma, follicular lymphoma, and B-cell acute lymphoblastic leukaemia.
- The trials span Phase 1, Phase 4, and Phase 4, with 212, 52, and 349 participants respectively.
- One trial compares MK-1045 with blinatumomab in relapsed/refractory B-cell acute lymphoblastic leukaemia.
- Key measurements include safety, adverse events, response rates, and survival.
- MK-1045 is supplied by Merck & Co. Inc. and has no marketing authorisation in these records.
What is MK-1045?
MK-1045 is an investigational protein-based substance. The registry records describe its origin as "Protein - Other", which means it is a protein-based medicine rather than a chemically synthesised small molecule. It is being studied in the disease area of neoplasms, which covers cancers. MK-1045 has no marketing authorisation in these product records, so it is not yet an approved medicine.
How does MK-1045 work?
The registry data do not describe the mechanism of action of MK-1045. No molecular target or biological pathway is stated in the trial records or product information provided. The trials focus on measuring safety, tolerability, and response rates, but the way MK-1045 acts in the body is not explained in these sources.
Which conditions is MK-1045 being studied for?
- Non-Hodgkin lymphoma — a cancer of the lymphatic system. One Phase 1 trial is testing MK-1045 alone, given intravenously or as a subcutaneous injection, in 212 participants.
- Follicular lymphoma — a slow-growing form of non-Hodgkin lymphoma. A Phase 4 trial is testing MK-1045 in combination with rituximab in 52 participants.
- Relapsed/refractory B-cell acute lymphoblastic leukaemia — a blood cancer that has come back or not responded to previous treatment. A Phase 4 trial is comparing MK-1045 with blinatumomab in 349 participants.
How is MK-1045 given?
MK-1045 is prepared as a solution for infusion. In the trials, it is given by intravenous infusion, which means it is delivered directly into a vein over a period of time. One trial also includes a subcutaneous injection arm, where the medicine is given under the skin. The registry records list both intravenous infusion and "other use" as routes of administration. Doses are not reported in the registry records for this substance.
What do the clinical trials show?
Three authorised trials are investigating MK-1045 in different blood cancers. They have not reported results yet, as all three are in the authorised stage, meaning they have been approved to start but have not published findings. The trials measure safety, tolerability, response rates, and survival.
What phases and status do the trials have?
One trial is Phase 1, and two trials are Phase 4. All three trials have the status "Authorised". The Phase 1 trial in non-Hodgkin lymphoma has 212 participants. The Phase 4 trial in follicular lymphoma has 52 participants. The Phase 4 trial in B-cell acute lymphoblastic leukaemia has 349 participants.
What are the trials measuring?
The trials measure several outcomes. In the non-Hodgkin lymphoma trial, the main measurements are the number of participants who experience an adverse event, the number who stop treatment because of an adverse event, dose-limiting toxicity in two arms, and objective response rate (ORR) — the proportion of participants whose cancer shrinks or disappears — assessed using Lugano Response Criteria. In the follicular lymphoma trial, Part 1 measures adverse events, treatment discontinuation due to adverse events, dose-limiting toxicity, and complete response rate; Part 2 measures progression-free survival (PFS), which is the time a participant lives without the cancer getting worse. In the B-cell acute lymphoblastic leukaemia trial, Part 1 measures complete remission (CR) within the first three treatment cycles, adverse events, and discontinuation due to adverse events; Part 2 measures the percentage of participants with complete remission and overall survival (OS), which is the time a participant lives.
Who can take part in these trials?
The trials enrol people with specific blood cancers. The non-Hodgkin lymphoma trial enrols people with non-Hodgkin lymphoma. The follicular lymphoma trial enrols people with follicular lymphoma. The B-cell acute lymphoblastic leukaemia trial enrols people with relapsed or refractory B-cell acute lymphoblastic leukaemia, meaning the disease has come back after treatment or has not responded to previous treatment. The registry records do not provide further details about inclusion or exclusion criteria.
What side effects are known?
No side effects are described in the sources provided. The trials are measuring adverse events as a primary outcome, but no results or known side effect profiles are available in the registry records or supplementary sources.