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Afm24

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.

Table of contents

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.[1] The study is listed as interventional, which means people in the trial received study treatment so researchers could measure its effects.[1]

Who the trial is for

This trial focused on people with advanced/metastatic EGFR-expressing cancers.[1] 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.[1] EGFR-expressing means the cancer cells show a specific marker called EGFR, which was used to define the study population.[1]

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.[1] 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.[1] Phase 2a then focused on early signs of anti-cancer activity for Afm24 in combination with other study drugs.[1]

Atezolizumab, docetaxel, and ramucirumab were listed among the study interventions in the source data.[1] 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.[1]

What researchers measured

In Phase 1, the main safety measure was dose-limiting toxicities, also called DLTs.[1] DLTs are side effects severe enough to limit further dose increases during the first treatment cycle.[1] Researchers used these data to help decide the safest dose level for later study.[1]

In Phase 2a, the main outcome was overall response rate (ORR) based on RECIST v1.1 and investigator assessment.[1] 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.[1]

Trial status and size

The trial is listed as completed in the source data.[1] The enrollment number was 262, which means 262 participants were included in the study.[1]

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.[1] 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.[1] This makes the trial important for understanding both safety and early effectiveness in a specific cancer group.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05109442 Phase 1 Advanced/Metastatic EGFR-expressing cancers Completed 262

FAQ

  • What is being studied in Afm24 clinical trials? The trial is studying Afm24 in people with advanced and metastatic EGFR-expressing cancers. It looks at safety, dose finding, and how well the treatment may work.
  • Who may take part in these trials? The trial is focused on patients with advanced or metastatic EGFR-expressing cancers. These are cancers that have spread or are hard to treat and show EGFR expression.
  • What trial phase is Afm24 being tested in? The study includes Phase 1 and Phase 2a parts. Phase 1 looks mainly at safety and dose selection, while Phase 2a looks more at anti-tumor activity.
  • What results are the researchers measuring? In Phase 1, the main focus is dose-limiting toxicities, which are side effects that limit how much treatment can be given. In Phase 2a, the main result is overall response rate, or ORR, which shows how many patients had their tumors shrink or disappear.
  • Is the Afm24 trial completed? Yes, the trial listed here is completed. It enrolled 262 participants.

Ongoing Clinical Trials on Afm24

  • Study of AFM24 and Atezolizumab for Patients with Advanced or Metastatic EGFR-expressing Cancers

    Not recruiting

    1 1 1 1 1
    Investigated drugs:
    Poland Spain

Glossary

  • Advanced cancer: Cancer that has grown more serious or spread beyond its original place.
  • Metastatic cancer: Cancer that has spread from the first tumor site to other parts of the body.
  • EGFR-expressing: A cancer that shows a protein called EGFR on its cells. Trials may use this feature to choose patients.
  • Phase 1: The first main stage of a clinical trial. It usually focuses on safety, side effects, and finding the right dose.
  • Phase 2a: An early part of Phase 2 that looks for early signs of how well a treatment works.
  • Dose escalation: A trial step where the study team gives higher doses over time to find a safe dose range.
  • Maximum tolerated dose (MTD): The highest dose people can take before side effects become too severe.
  • Recommended Phase 2 dose (RP2D): The dose chosen for later testing because it appears safe and suitable.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to stop dose increases or limit treatment.
  • Overall response rate (ORR): The number of patients whose cancer shrinks or disappears during treatment.
  • RECIST v1.1: A standard way doctors use scans to measure whether a tumor is getting smaller, staying the same, or growing.
  • Interventional study: A study where participants receive a treatment or intervention so researchers can measure its effects.

References