Table of contents
- Clinical trial overview
- Prostate cancer studies
- Other advanced cancers
- Main trial goals and endpoints
- Who can take part
- Trial status and size
Clinical trial overview
Tulmimetostat is being studied in interventional clinical trials, which means researchers give a treatment and follow what happens.[1][2][3] The available studies are all listed as Authorised and are testing Tulmimetostat in people with advanced cancers.[1][2][3]
These trials are mainly early-stage studies, with Phase 1 and Phase 2 research.[1][2] Early phases usually focus on safety, dose finding, and whether the treatment can be given in a way that people can tolerate.
Prostate cancer studies
Two of the studies focus on men with advanced prostate cancer.[2][3] One study is in metastatic hormone-sensitive prostate cancer (mHSPC), which means the cancer has spread but still responds to hormone lowering treatment.[2] Another study is in metastatic castrate resistant prostate cancer (mCRPC), which means the cancer has spread and is no longer controlled by lowering testosterone.[3]
The mHSPC study, TulmiSTAR-02, compares Tulmimetostat with darolutamide versus darolutamide alone, and also studies Tulmimetostat with abiraterone.[2] The mCRPC study tests Tulmimetostat with JSB462 and also includes other prostate cancer treatments in the study design, such as abiraterone, enzalutamide, docetaxel, cabazitaxel, and luxdegalutamide.[3]
In the prostate cancer trials, the main results being measured include PSA changes, especially PSA50 and biochemical response rate.[2][3] PSA is a blood test used to help track prostate cancer activity.
Other advanced cancers
One larger study is looking at Tulmimetostat in people with advanced solid tumors and lymphomas.[1] This includes several cancer types such as urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, lymphoma, malignant pleural or peritoneal mesothelioma, and metastatic castration-resistant prostate cancer.[1]
This study uses Tulmimetostat alone in some parts and also tests it with enzalutamide in a prostate cancer cohort.[1] The trial is designed to learn both the best dose and the antitumor activity, which means whether the treatment may shrink or control the cancer.[1]
Main trial goals and endpoints
The first goal in the early parts of the studies is to find the safest dose range and the recommended Phase 2 dose or recommended dose for expansion.[1][2][3] A dose-limiting toxicity is a side effect serious enough to limit treatment, and it is measured closely in the first treatment cycles.[1][3]
The studies also measure safety and tolerability by tracking adverse events, lab values, vital signs, electrocardiograms, dose interruptions, dose reductions, and treatment stop rates.[2][3] Tolerability means how well people can stay on treatment without needing major changes.
Later study goals look at efficacy, which means whether the treatment helps the cancer.[1][2][3] In the solid tumor and lymphoma study, the main efficacy endpoint is overall response rate, meaning the share of patients with complete or partial tumor shrinkage.[1] In the prostate cancer studies, the main efficacy endpoints are PSA50 and biochemical response rate at 6 months.[2][3]
Who can take part
The studies are aimed at adults with advanced cancers, but each trial has its own entry rules.[1][2][3] The main groups include people with advanced solid tumors, lymphomas, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer.[1][2][3]
Some study parts are for monotherapy, which means Tulmimetostat is used by itself, while other parts are for combination therapy, which means it is given with another cancer medicine.[1][2][3] The exact fit depends on the cancer type, the study part, and the treatment already received.
Trial status and size
All three studies listed in the source data are marked Authorised.[1][2][3] The studies are fairly large for early research, with planned enrollment of 275, 149, and 188 participants.[1][2][3]
The larger solid tumor and lymphoma study is Phase 1/2, while the two prostate cancer studies are Phase 1 studies that also include later expansion or comparison parts.[1][2][3] This shows that Tulmimetostat is still being tested to learn the best way to use it in cancer care.
