Study on the Safety and Effectiveness of OBX-115 for Advanced Solid Tumors

Sponsor: Obsidian Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06060613

Provider View

This clinical trial is testing a new treatment called OBX-115 to see if it is safe and effective for adults with advanced solid tumors, such as certain types of skin and lung cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment, OBX-115, in adults with advanced solid tumors. Researchers aim to determine how well the treatment works in shrinking tumors and how long the effects last. The study will also assess the overall survival of participants and the feasibility of producing the treatment for use in patients.

Description

This study is divided into two phases. In Phase 1, the main goal is to assess the safety and tolerability of the OBX-115 treatment. In Phase 2, researchers will evaluate how effective the treatment is in reducing tumor size, as measured by specific medical criteria.

Secondary goals for both phases include:

  • Determining how long the treatment's effects last before the cancer progresses or the patient passes away.
  • Evaluating the percentage of participants whose cancer is controlled by the treatment, including those whose cancer shrinks or remains stable for at least four weeks.
  • Measuring the time from the start of treatment until the cancer progresses or the patient passes away.
  • Assessing the overall survival time from the start of treatment.
  • Evaluating the feasibility of producing the OBX-115 treatment for patient use.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced melanoma or relapsed/refractory metastatic non-small cell lung cancer (NSCLC).
  • For melanoma, must have experienced disease progression after treatment with PD-1/PD-L1 blocking antibodies. If the tumor has a BRAF V600 mutation, must have received a BRAF inhibitor, with or without a MEK inhibitor. For NSCLC, must have relapsed or be refractory to approved systemic therapies.
  • Must have at least one tumor suitable for OBX-115 treatment.
  • Must have at least one measurable tumor remaining after tumor tissue is collected.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities, and an estimated life expectancy of more than 6 months.
  • Must have recovered from any side effects of previous cancer treatments to a mild level.
  • Must have completed recovery from any previous surgeries.
  • Must agree to use effective contraception or abstain from sex if of childbearing potential.
  • Must meet specific blood count and organ function requirements.

Exclusion Criteria

  • Have melanoma originating from the eye.
  • Have a history of brain metastases or cancer spread to the brain lining, unless treated and stable.
  • Have any active medical conditions that increase risks for study participation.
  • Have NSCLC with significant fluid buildup in the chest.
  • Have any form of immune system deficiency.
  • Have a history of allergic reactions to the study treatment.
  • Have had another primary cancer within the last 3 years, with some exceptions.
  • Have a history of organ or cell transplants, except for certain cell therapies.
  • Require more than 10 mg/day of prednisone or equivalent steroids.
  • Have received a live vaccine within 28 days before starting treatment.
  • Have active infections or positive infectious disease screening.

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