In short
Clinical trials are studying Afm24 in people with advanced and metastatic EGFR-expressing cancers. The research is looking at safety, dose selection, and signs of anti-cancer activity, including in combination with other study drugs. The main goal is to learn whether Afm24 can help these patient groups.
Key points
- Clinical trials of Afm24 are studying people with advanced and metastatic EGFR-expressing cancers. The listed study was a Phase 1/2a interventional trial and is now completed. Researchers wanted to find a safe dose, identify the maximum tolerated dose or recommended Phase 2 dose, and look for early signs that the treatment may work. The main efficacy measure in Phase 2a was overall response rate, which shows how many tumors responded to treatment. The trial enrolled 262 participants. The study focused on patients with cancers that had already advanced or spread.
Trial overview
The main study in the source data is NCT05109442, a Phase 1/2a trial of Afm24 in patients with advanced and metastatic EGFR-expressing cancers. The study is listed as interventional, which means people in the trial received study treatment so researchers could measure its effects.
Who the trial is for
This trial focused on people with advanced/metastatic EGFR-expressing cancers. Advanced cancer means the disease is more serious or has grown beyond its original site, and metastatic cancer means it has spread to other parts of the body. EGFR-expressing means the cancer cells show a specific marker called EGFR, which was used to define the study population.
Study phases and goals
The trial had a dose escalation part in Phase 1, which is an early step used to find a safe dose range. In this part, researchers aimed to determine the maximum tolerated dose and/or select one or more recommended Phase 2 doses of Afm24 in combination with atezolizumab. Phase 2a then focused on early signs of anti-cancer activity for Afm24 in combination with other study drugs.
Atezolizumab, docetaxel, and ramucirumab were listed among the study interventions in the source data. The trial data only shows that these drugs were part of the study plan; it does not give more detail here about how each one was used.
What researchers measured
In Phase 1, the main safety measure was dose-limiting toxicities, also called DLTs. DLTs are side effects severe enough to limit further dose increases during the first treatment cycle. Researchers used these data to help decide the safest dose level for later study.
In Phase 2a, the main outcome was overall response rate (ORR) based on RECIST v1.1 and investigator assessment. ORR is the percentage of patients whose tumors shrink or disappear during treatment, and RECIST v1.1 is a standard scan-based system for measuring tumor response.
Trial status and size
The trial is listed as completed in the source data. The enrollment number was 262, which means 262 participants were included in the study.
Study design and treatments
The study was designed to test Afm24 in combination with other cancer treatments rather than as a single research question only. The brief summary says Phase 1 was used to determine the MTD and/or RP2Ds, while Phase 2a was used to evaluate anti-tumor activity in terms of ORR. This makes the trial important for understanding both safety and early effectiveness in a specific cancer group.