Study of IT STX-001 for Patients with Advanced Solid Tumors, Alone or with Pembrolizumab

Sponsor: Strand Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06249048

Provider View

This clinical trial is testing a new treatment called STX-001, given either by itself or with another drug called pembrolizumab, to see if it is safe and effective for patients with advanced solid tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment, STX-001, for patients with advanced solid tumors. The treatment is given directly into the tumor and can be used alone or with pembrolizumab, a drug that helps the immune system fight cancer. The study aims to find out if STX-001 is safe, how it behaves in the body, and if it can help shrink tumors. The study is divided into two phases: Phase 1 will test different doses to find the safest and most effective amount, while Phase 2 will focus on specific types of cancer, like triple negative breast cancer and melanoma, to see how well the treatment works.

Description

This study is testing a new cancer treatment called STX-001, which is given directly into the tumor. The study is in two parts: Phase 1 and Phase 2. In Phase 1, researchers will test different doses of STX-001 to find the safest and most effective amount. Some patients will receive STX-001 alone, while others will receive it with pembrolizumab, a drug that helps the immune system fight cancer. New patients will join each group to test different doses.

In Phase 2, the study will focus on two specific types of cancer: triple negative breast cancer and melanoma. Researchers will use the best dose from Phase 1 to see how well the treatment works in these cancers. The goal is to find out if STX-001 can help shrink tumors and improve patient outcomes.

Throughout the study, researchers will monitor patients for any side effects and measure how the treatment affects the cancer. Patients will need to provide blood samples and may need to have a biopsy of the tumor before and after treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must be in good general health, able to carry out normal activities or light work.
  • Must have a life expectancy of at least 12 weeks.
  • Must weigh more than 40 kg (about 88 pounds).
  • Must be at least 4 weeks past any major surgery.
  • Must be willing to provide blood samples.
  • Must have a tumor that can be injected with the treatment.
  • Must have certain blood and organ function levels within normal ranges.

Phase 1:

  • Must have advanced or spreading solid tumors that have not responded to standard treatments.

Phase 2 (Triple Negative Breast Cancer):

  • Must have triple negative breast cancer that cannot be treated with surgery or other therapies.
  • Must have received certain previous treatments.
  • Must have measurable disease besides the injected tumor.

Phase 2 (Melanoma):

  • Must have advanced melanoma that cannot be treated with surgery or other therapies.
  • Must have received certain previous treatments.
  • Must have measurable disease besides the injected tumor.

Exclusion Criteria

  • History of autoimmune disease or need for immunosuppressive treatment (except for hypothyroidism).
  • History of organ transplant.
  • Recent serious heart problems or stroke.
  • Active infection needing IV antibiotics.
  • Uncontrolled bleeding or serious wounds.
  • Known HIV, hepatitis B, or hepatitis C infection.
  • Untreated brain tumors or metastases.
  • Another untreated cancer.
  • Serious illness that would interfere with the study.
  • Previous treatment with IL-12.
  • Recent vaccination or other cancer treatment.
  • Currently in another clinical trial.
  • Severe allergy to study drugs.
  • Mental health or substance use issues affecting study participation.
  • Pregnant or breastfeeding women, or those planning to become pregnant.
  • Women of childbearing potential not using effective contraception.
  • Unwilling or unable to follow study requirements.

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