Study on Mocertatug Rezetecan with Other Cancer Treatments for Advanced Solid Tumors

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT06796907

This clinical trial is testing a new treatment called Mocertatug Rezetecan (Mo-Rez) in combination with other cancer therapies to see if it is safe and effective for people with advanced solid tumors that have spread and are not responding to standard treatments.

Patient Parameters

Program Overview

Advanced solid tumors are cancers that have spread to other parts of the body and often become resistant to existing treatments. This study is exploring a new treatment, Mocertatug Rezetecan (Mo-Rez), combined with other cancer medicines, to see if it is safe, how the body processes it, and how well it works. The study includes participants with advanced solid tumors who have not responded to standard treatments, cannot tolerate them, or have no other effective treatment options.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to give informed consent and follow study requirements.
  • Have a confirmed diagnosis of advanced solid tumor with no more than 4 previous treatments.
  • Provide a tumor tissue sample for testing.
  • Have at least one measurable tumor that has not been treated with local therapies.
  • Have a life expectancy of at least 12 weeks.

For Endometrial Cancer (Mo-Rez + Dostarlimab):

  • Have advanced or recurrent endometrial cancer not responding to standard treatments.

For Ovarian Cancer (Mo-Rez +/- Bevacizumab):

  • Have advanced ovarian cancer that has relapsed more than 6 months after last platinum treatment.

  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.

  • Have a performance status of 0 to 1, indicating full activity or some restriction in strenuous activities.

  • Have normal organ and bone marrow function.

Exclusion Criteria

  • Have another cancer that has progressed or needed treatment in the past 24 months, except for certain skin or in-situ cancers.
  • Have had major surgery within 28 days before joining the study.
  • Have had a bone marrow or organ transplant.
  • Have allergies to study drugs or components.
  • Have significant heart problems or abnormal heart rhythms.
  • Have untreated or rapidly progressing brain metastases.
  • Have lung disease or a history of lung inflammation.
  • Have autoimmune diseases needing treatment in the past 2 years.
  • Have significant bleeding issues or tumors causing bleeding.
  • Have uncontrolled high blood pressure.
  • Have serious kidney problems.
  • Have serious or unstable medical or psychiatric conditions.
  • Have a history of HIV.

For Endometrial Cancer (Mo-Rez + Dostarlimab):

  • Have uterine sarcoma or severe immune-related side effects from prior treatments.

For Ovarian Cancer (Mo-Rez +/- Bevacizumab):

  • Have wound healing issues or certain gastrointestinal problems.
  • Have significant heart or kidney issues.
  • Have liver enzyme or bilirubin levels above specified limits.
  • Have hepatitis B or C infections.
  • Have had certain prior cancer treatments or drugs within specified timeframes.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site92093La JollaCalifornia
GSK Investigational Site55905-0001RochesterNew York
GSK Investigational Site27710DurhamNorth Carolina
GSK Investigational Site43210ColumbusOhio

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