In short
Clinical trials are studying Acasunlimab in several cancer types, including solid tumors, melanoma, and non-small cell lung cancer. These studies look at safety, effectiveness, and the best dose, both alone and with pembrolizumab. The target groups include people with advanced, relapsed, or treatment-resistant cancer.
Key points
- Clinical trials of Acasunlimab are being done in several cancer types, including solid tumors, melanoma, and non-small cell lung cancer. The studies include Phase 1/2, Phase 2, and Phase 3 trials, so they are looking at both early safety and later effectiveness. Some trials test Acasunlimab alone, while others test it with pembrolizumab. The target groups include people with advanced, relapsed, refractory, or metastatic cancer. Main outcomes include safety, tumor response, and overall survival.
Trial overview
The clinical trials in this group study Acasunlimab in people with different types of cancer.
The studies are interventional, which means the researchers give a treatment and then measure the results.
The trial phases range from Phase 1/2 to Phase 3, so the program includes early safety testing and later testing of how well the treatment works.
Malignant solid tumors study
NCT03917381 is a Phase 1/2 safety trial in patients with malignant solid tumors.
The cancers listed for this study are endometrial carcinoma, urothelial carcinoma, triple-negative breast cancer, squamous cell carcinoma of the head and neck, and cervical cancer.
The study includes dose escalation, which means the treatment amount is gradually adjusted to find the highest dose that can be given safely.
The brief summary says the study aims to find the maximum tolerated dose, the recommended Phase 2 dose, the safety profile, and clinical efficacy.
The main outcomes include dose-limiting toxicities, adverse events, changes in safety laboratory tests, and objective response rate in an expansion cohort.
Melanoma study
NCT06984328 is a Phase 2 study in advanced cutaneous melanoma, also called skin melanoma.
It includes relapsed/refractory disease, locally advanced unresectable disease, and metastatic disease, which means the cancer came back, did not respond, cannot be removed with surgery, or has spread.
This study tests Acasunlimab alone and together with pembrolizumab.
The main endpoint is objective response rate, measured by the investigator using RECIST v1.1, a standard way to measure tumor changes.
The brief summary says the goal is to evaluate antitumor activity, which means how well the treatment fights the cancer.
Non-small cell lung cancer studies
NCT06635824 is a Phase 3 trial in non-small cell lung cancer.
This study compares Acasunlimab plus pembrolizumab against docetaxel as second- or third-line treatment after prior PD-1/PD-L1 inhibitor therapy and platinum-based standard care.
The main endpoint is overall survival, which looks at how long patients live after treatment starts.
NCT05117242 is a Phase 2 study in relapsed or refractory metastatic non-small cell lung cancer.
It studies Acasunlimab as a single agent or with pembrolizumab, and the main endpoint is objective response rate by investigator review using RECIST v1.1.
Main endpoints and what they mean
The trials use several important endpoints, or main results they want to measure.
- Safety endpoints include dose-limiting toxicities, adverse events, and changes in laboratory tests.
- Objective response rate shows how many patients had a tumor response, such as complete response or partial response.
- Overall survival is used in the Phase 3 lung cancer study to see whether one treatment helps people live longer.
Who may take part
These trials focus on people with advanced cancer, cancer that has returned, cancer that did not respond to earlier treatment, or cancer that has spread.
The exact eligibility rules are not fully listed in the source data, so participation depends on the specific trial and cancer type.
The studies also show that Acasunlimab is being tested both by itself and in combination with pembrolizumab, depending on the trial.