Study on IPG7236 for Patients with Advanced Solid Tumors

Sponsor: Nanjing Immunophage Biotech Co., Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05142592

This clinical trial is testing a new oral medication, IPG7236, to see if it is safe and effective in treating adults with advanced solid tumors. The study will explore different doses to find the best one for future research.

Patient Parameters

Program Overview

This study is the first to test IPG7236 in humans and involves two phases. The first phase will determine the safest dose, and the second phase will expand to more patients to further assess its effects. Participants will take the medication twice daily on an empty stomach in 28-day cycles. The study includes a screening period, treatment period, and follow-up to monitor safety and effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or recurrent solid tumors that cannot be surgically removed.
  • Must have tried standard treatments for their cancer type without success or cannot tolerate them.
  • Must have measurable disease according to specific criteria.
  • Must have a life expectancy of at least 3 months.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have adequate blood and organ function based on specific lab tests.
  • Must be able to swallow pills and follow study requirements.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • Men with partners of childbearing potential must use effective birth control or be surgically sterile.

Exclusion Criteria

  • Have cancer of the central nervous system or related to HIV or organ transplant.
  • Have not recovered from side effects of previous cancer treatments.
  • Have had recent cancer treatments or major surgery within specified timeframes.
  • Have uncontrolled diseases or active infections that could affect the study.
  • Have positive COVID-19 tests unless cleared by the investigator.
  • Have received live vaccines recently or plan to during the study.
  • Have active hepatitis B or C, or uncontrolled HIV.
  • Have had another cancer within the last 3 years, with some exceptions.
  • Have untreated or unstable brain or spinal cord metastases.
  • Have digestive issues affecting drug absorption.
  • Have heart rhythm issues or take medications affecting heart rhythm.
  • Are pregnant or breastfeeding, or not using effective contraception if of childbearing potential.
  • Cannot comply with study procedures.

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