Study on SMP-3124LP for Adults with Advanced Solid Tumors

Sponsor: Sumitomo Pharma America, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06526819

Provider View

This clinical trial is testing a new drug, SMP-3124LP, to see if it is safe and can help treat adults with advanced solid tumors. The study will explore different doses to find the most effective and safe amount for future treatments.

Patient Parameters

Program Overview

This study is designed to evaluate the safety and initial effectiveness of a new drug called SMP-3124LP in adults with advanced solid tumors. It will involve two phases: the first phase will test different doses to find the safest and most effective one, while the second phase will expand on this to further assess the drug's impact on tumors.

Description

This clinical trial is a global, first-in-human study to assess the safety, tolerability, and initial effectiveness of SMP-3124LP in adults with advanced solid tumors. The study will be conducted in two parts: Phase 1 will focus on finding the safest dose, and Phase 2 will expand to evaluate the drug's effect on tumors. Participants will receive the drug and undergo various tests to monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced, recurrent, or metastatic cancer that has not responded to standard treatments and for which no other effective treatments are available.
  • Specific types of cancer include:
    • Platinum-resistant ovarian cancer
    • Triple negative breast cancer
    • Squamous cell carcinoma of the anus
    • Squamous cell carcinoma of the head and neck
    • Non-small cell lung cancer
    • Uterine serous cancer
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have recovered from any previous treatment side effects.
  • Have adequate organ function as shown by specific blood tests.
  • Agree to use effective contraception during the study and for six months after the last dose.
  • May be HIV positive if certain conditions are met, such as having a stable CD4 count and low viral load.
  • Have controlled hepatitis B or C infections, if applicable.

Exclusion Criteria

  • Have previously received treatment with certain cell cycle checkpoint inhibitors.
  • Have an allergy or sensitivity to any component of SMP-3124LP.
  • Have received cancer treatment or participated in another clinical trial within 14 days before starting this study.
  • Have had major surgery within 28 days or minor surgery within 7 days before starting the study.
  • Are using certain medications that affect liver enzymes within 14 days before starting the study.
  • Have cancer that has spread to the brain or spinal cord.
  • Have another type of cancer that could interfere with the study.
  • Have significant heart problems or abnormal heart rhythms.
  • Have an active, uncontrolled infection requiring treatment.
  • Are pregnant or breastfeeding. Women must stop breastfeeding for at least six months after the last dose.
  • Have a history of bowel obstruction related to ovarian cancer within three months before starting the study.
  • Have platinum-refractory ovarian cancer, meaning the cancer progressed during platinum-based chemotherapy.
  • Have any other medical or psychiatric condition that could interfere with the study.
  • Are taking medications that are not allowed in the study.

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