Study on APL-5125 for Adults with Advanced Solid Tumors

Sponsor: Apollo Therapeutics Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06399757

Provider View

This clinical trial is testing a new drug, APL-5125, to see if it is safe and effective for treating certain advanced solid tumors, with a focus on colorectal cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of a new treatment called APL-5125 in adults with advanced solid tumors, particularly colorectal cancer. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is divided into two phases: Phase 1 includes various types of advanced tumors, while Phase 2 focuses specifically on colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • For Phase 1: Must have a confirmed diagnosis of an advanced or metastatic tumor, such as colorectal cancer, cholangiocarcinoma, or appendiceal adenocarcinoma. Other eligible cancers for sub-studies include pancreatic, gastric, endometrial, triple-negative breast, ovarian, and prostate cancer.
  • For Phase 2: Must have colorectal cancer.
  • No standard treatment options available, or not eligible for standard treatment, except for colorectal cancer patients who must have tried specific chemotherapy and targeted therapies.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must weigh at least 40 kg (about 88 pounds).
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstain from intercourse during the study.
  • Men must agree to use effective contraception and not donate sperm during the study.
  • Must be willing to provide written consent and follow study requirements.

Exclusion Criteria

  • Certain medical conditions, such as active brain cancer spread, heart problems, uncontrolled infections, recent significant bleeding, or recent major stomach surgery.
  • Recent cancer treatments, including chemotherapy or radiation within a few weeks before the study.
  • Use of certain medications or supplements shortly before the study.
  • Recent major surgery.
  • Low blood cell counts or poor liver or kidney function based on specific tests.
  • Heart rhythm issues or family history of Long QT Syndrome.
  • Poor heart function based on specific tests.
  • Positive tests for HIV (unless controlled), hepatitis B, or hepatitis C.

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