Study on the Safety and Effects of LB101 in Adults with Advanced Solid Tumors

Sponsor: Centessa Pharmaceuticals (UK) Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05821777

Provider View

This clinical trial is testing a new treatment called LB101 to see if it is safe and how it works in adults with advanced solid tumors. The study will help determine the best dose for future research.

Patient Parameters

Program Overview

The purpose of this study is to find out if the new treatment LB101 is safe and how it affects adults with advanced solid tumors. The study is divided into two parts: the first part will test different doses to find the best one, and the second part will further evaluate the treatment's safety and effectiveness.

Description

This study is divided into two parts. The first part involves testing different doses of LB101 to find the best one for treating advanced solid tumors. This part is called 'First in Human' and includes dose escalation and optimization. The second part will expand on the first part's findings to further assess the treatment's safety, effectiveness, and how it interacts with the body and immune system. Participants will receive LB101 and undergo various tests to monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Must sign an informed consent form.
  • Have an advanced, unresectable, or metastatic solid tumor with no standard treatment options available or have not responded to previous treatments.
  • Specific types of cancer include:
    • Non-small cell lung cancer (NSCLC) that is PD-L1 positive and has received certain treatments.
    • Head and neck squamous cell carcinoma or cervical cancer that is PD-L1 positive and has received immune checkpoint inhibitors.
    • Cutaneous squamous cell cancer that has received immune checkpoint inhibitors.
    • Colorectal cancer with specific genetic markers.
    • Ovarian cancer that is resistant to platinum-based treatments.
    • Gastric cancer that is PD-L1 positive and has received certain treatments.
  • Must have measurable disease according to specific criteria.
  • Must provide a tumor tissue sample.
  • Must have a good performance status and adequate blood, liver, and kidney function.
  • Must have a life expectancy of at least 12 weeks and weigh at least 40 kilograms.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception.
  • Men must use effective contraception if they can father a child.

Exclusion Criteria

  • Unknown or negative PD-L1 status for certain cancers.
  • Have not received checkpoint inhibitors for advanced/metastatic disease unless not approved for their condition.
  • Progressed within 6 months of completing adjuvant therapy.
  • Previous exposure to certain anticancer therapies.
  • Participating in another clinical study.
  • Have ongoing side effects from previous treatments.
  • Have received immunosuppressive drugs recently.
  • Have received a live vaccine recently.
  • Have primary brain tumors or certain brain metastases.
  • Have severe allergic reactions to similar treatments.
  • Have active autoimmune diseases or infections.
  • Have a history of HIV, hepatitis B, or hepatitis C.
  • Have had organ or stem cell transplants.
  • Have had severe side effects from previous immunotherapy.
  • Have significant fluid buildup or respiratory issues.
  • Have uncontrolled heart disease.
  • Have other serious health conditions or psychiatric disorders.
  • Have a history of other advanced cancers unless cured for over 2 years.
  • Pregnant or breastfeeding women.

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