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Acasunlimab

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.

Table of Contents

Trial overview

The clinical trials in this group study Acasunlimab in people with different types of cancer.[1][2][3][4]

The studies are interventional, which means the researchers give a treatment and then measure the results.[1][2][3][4]

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.[1][3]

Malignant solid tumors study

NCT03917381 is a Phase 1/2 safety trial in patients with malignant solid tumors.[1]

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.[1]

The study includes dose escalation, which means the treatment amount is gradually adjusted to find the highest dose that can be given safely.[1]

The brief summary says the study aims to find the maximum tolerated dose, the recommended Phase 2 dose, the safety profile, and clinical efficacy.[1]

The main outcomes include dose-limiting toxicities, adverse events, changes in safety laboratory tests, and objective response rate in an expansion cohort.[1]

Melanoma study

NCT06984328 is a Phase 2 study in advanced cutaneous melanoma, also called skin melanoma.[2]

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.[2]

This study tests Acasunlimab alone and together with pembrolizumab.[2]

The main endpoint is objective response rate, measured by the investigator using RECIST v1.1, a standard way to measure tumor changes.[2]

The brief summary says the goal is to evaluate antitumor activity, which means how well the treatment fights the cancer.[2]

Non-small cell lung cancer studies

NCT06635824 is a Phase 3 trial in non-small cell lung cancer.[3]

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.[3]

The main endpoint is overall survival, which looks at how long patients live after treatment starts.[3]

NCT05117242 is a Phase 2 study in relapsed or refractory metastatic non-small cell lung cancer.[4]

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.[4]

Main endpoints and what they mean

The trials use several important endpoints, or main results they want to measure.[1][2][3][4]

  • Safety endpoints include dose-limiting toxicities, adverse events, and changes in laboratory tests.[1]

  • Objective response rate shows how many patients had a tumor response, such as complete response or partial response.[1][2][4]

  • Overall survival is used in the Phase 3 lung cancer study to see whether one treatment helps people live longer.[3]

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.[2][3][4]

The exact eligibility rules are not fully listed in the source data, so participation depends on the specific trial and cancer type.[1][2][3][4]

The studies also show that Acasunlimab is being tested both by itself and in combination with pembrolizumab, depending on the trial.[2][4]

Trial ID Phase Condition studied Status Enrollment
NCT03917381 Phase 1/2 Malignant solid tumors, including endometrial, urothelial, triple-negative breast, head and neck squamous cell, and cervical cancer Authorised 427
NCT06984328 Phase 2 Advanced cutaneous melanoma, including relapsed/refractory, locally advanced unresectable, and metastatic disease Completed 166
NCT06635824 Phase 3 Non-small cell lung cancer Authorised 702
NCT05117242 Phase 2 Relapsed/refractory metastatic non-small cell lung cancer Authorised 128

FAQ

  • What is being studied in Acasunlimab trials? The trials study Acasunlimab alone or with pembrolizumab in different cancers. They measure safety, tumor response, and survival-related outcomes.
  • Who can join these trials? People with advanced or relapsed cancer may be eligible, depending on the study. The trials include patients with solid tumors, melanoma, or non-small cell lung cancer.
  • What trial phases are listed for Acasunlimab? The studies are in Phase 1/2, Phase 2, and Phase 3. Earlier phases focus more on safety and dose, while later phases compare how well treatments work.
  • Which cancers are being studied? The trials include malignant solid tumors such as endometrial, urothelial, triple-negative breast, head and neck squamous cell, and cervical cancer. They also include melanoma and non-small cell lung cancer.
  • What outcomes do the trials measure? The main outcomes include dose-limiting toxicities, adverse events, objective response rate, and overall survival. These help show safety and how well the treatment works.

Ongoing Clinical Trials on Acasunlimab

  • Study of Acasunlimab Alone and Combined With Pembrolizumab in Patients With Advanced Skin Melanoma That Returned or Did Not Respond to Prior Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany The Netherlands Spain

  • Study Comparing Acasunlimab and Pembrolizumab with Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Estonia France +9

  • Safety Study of GEN1046 and Pembrolizumab in Patients with Malignant Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    Hungary Italy Poland Spain

  • Study on the Safety and Effectiveness of Acasunlimab and Pembrolizumab for Patients with Recurrent Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Portugal +1

Glossary

  • Phase 1/2: A study stage that first checks safety and dose, then looks more closely at early signs of benefit.
  • Phase 2: A trial stage that mainly looks at whether a treatment helps and continues to watch safety.
  • Phase 3: A larger trial stage that compares treatments in more people to see which works better.
  • Interventional study: A trial where participants receive a treatment or combination of treatments so researchers can measure the results.
  • Dose-limiting toxicity: A side effect serious enough to limit how much of a treatment can be given.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Safety laboratory parameters: Blood test results and other lab values used to check if a treatment is affecting the body in a harmful way.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear based on standard tumor measurement rules.
  • Complete response (CR): When no visible signs of cancer are found after treatment.
  • Partial response (PR): When the cancer gets smaller, but does not disappear completely.
  • Overall survival (OS): The length of time people are alive after joining a trial or starting treatment.
  • RECIST: A standard way to measure how tumors change in size during cancer trials.

References