Study on Cancer Vaccine Labvax 3(22)-23 and GM-CSF Alone or with Pembrolizumab for Treating Advanced Adenocarcinoma

Sponsor: Tianhong Li

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05101356

Provider View

This clinical trial is testing a new cancer vaccine, Labvax 3(22)-23, with GM-CSF, and possibly with pembrolizumab, to see if it can help treat advanced adenocarcinoma, a type of cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new cancer vaccine called Labvax 3(22)-23, used alone or with GM-CSF, and possibly combined with pembrolizumab, in treating advanced adenocarcinoma. Labvax 3(22)-23 targets a protein called labyrinthin found on adenocarcinoma cells but not on normal cells. The vaccine aims to teach the immune system to attack these cancer cells. GM-CSF helps boost the immune response, and pembrolizumab may enhance the treatment's effectiveness. The study will help understand how well Labvax 3(22)-23 works in fighting adenocarcinoma.

Description

In Phase 1, up to 10 participants with advanced adenocarcinoma were given the Labvax 3(22)-23 vaccine and GM-CSF over several weeks. They were monitored for 16 weeks to check for safety and any side effects. This phase is now complete.

In Phase 2, up to 67 participants with advanced lung adenocarcinoma or other types of adenocarcinoma will receive pembrolizumab every three weeks, along with the Labvax 3(22)-23 vaccine and GM-CSF at specific intervals. The treatment will last up to 34 weeks, with follow-up visits to monitor safety and effectiveness. The study will stop if the treatment is not safe or effective enough.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be 18 years or older with a confirmed diagnosis of adenocarcinoma.
  • Must have advanced or recurrent cancer that can be measured.
  • For Phase 2, must have labyrinthin-positive lung adenocarcinoma and have received certain prior treatments.
  • Must be eligible for pembrolizumab therapy.
  • Must have tried other cancer treatments without success or had side effects.
  • Must have good overall health and organ function.
  • Women must not be pregnant and must use birth control.
  • Must provide a tumor sample for analysis.

Exclusion Criteria

  • Cannot have autoimmune diseases needing strong immunosuppressive drugs.
  • Cannot have had a spleen removed.
  • Cannot be pregnant or nursing.
  • Cannot have other serious medical conditions or infections.
  • Cannot have allergies to study drugs.
  • Cannot have had recent cancer treatments or surgeries without recovery.
  • Cannot have untreated or unstable brain metastases.
  • Cannot have severe lung disease or active infections.
  • Cannot have active hepatitis B or C.
  • Cannot have received a live vaccine recently.

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