Study on APG-115 Alone or with Pembrolizumab for Patients with Metastatic Melanomas or Advanced Solid Tumors

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03611868

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, APG-115, either by itself or combined with pembrolizumab, in treating patients with metastatic melanomas or advanced solid tumors. The study aims to see if this treatment can help the immune system fight cancer more effectively.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and potential benefits of APG-115, a drug that targets a specific cancer pathway, either alone or in combination with pembrolizumab, an immunotherapy drug. The study focuses on patients with metastatic melanomas or advanced solid tumors, aiming to see if this combination can help the immune system kill cancer cells more effectively.

Description

This study is in its early phases (Phase I/II) and is designed to test the safety and tolerability of APG-115, either alone or with pembrolizumab, in patients with various types of advanced cancers, including melanoma, non-small cell lung cancer (NSCLC), and others. The study will involve about 230 participants and aims to see if this treatment can improve outcomes like response rates and progression-free survival. Participants will be monitored for side effects and how well the treatment works against their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be male or non-pregnant, non-breastfeeding female, aged 18 or older. Adolescents aged 12 and up (weighing at least 40 kg) are allowed for certain cancer types.
  • Must have measurable cancer according to specific medical criteria.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have specific types of cancer, such as unresectable or metastatic melanoma, that have not responded to previous treatments.
  • Must have a life expectancy of at least 3 months.
  • Must have manageable side effects from previous cancer treatments.
  • Must have adequate bone marrow and organ function without needing continuous supportive treatment.
  • Must have a normal heart rhythm and function as measured by specific tests.
  • Must provide a tumor sample for analysis before starting the study treatment.
  • Must agree to use effective contraception during the study and for at least three months after the last dose.
  • Must be able to understand and sign a written consent form.

Exclusion Criteria

  • Have previously received treatment with an MDM2-p53 inhibitor.
  • Have received chemotherapy or certain other cancer treatments within a specified time before starting the study.
  • Have active or untreated cancer that has spread to the brain or spinal cord.
  • Require ongoing corticosteroid treatment, except for certain types of local use.
  • Have had major surgery or are not fully recovered from previous surgeries.
  • Have significant heart problems or recent heart procedures.
  • Have active infections or chronic inflammatory conditions.
  • Have received a live vaccine recently.
  • Have had an organ transplant or severe allergic reactions to similar treatments.
  • Have any other condition that makes participation in the study unsuitable, as judged by the investigator.
  • Women who are pregnant or have a positive pregnancy test before starting treatment.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.