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Closed (no longer recruiting)Last updated: 31 January 2024

IV Sting: This phase I trial is trying to determine the recommended dose of a new intravenous therapy (GSK3745417), when given alone or in combination with a type of immunotherapy, in patients with solid cancer typesA Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

Clinical summary

Summary

This is a dose escalation and expansion trial. In part 1 of the study, participants will receive an intravenous dose of GSK3745417 alone, at one week intervals. In part 2, GSK3745417 will be co-administered with 200mg IV pembrolizumab once every three weeks.

Conditions

This trial is treating patients with solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

IV Sting

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

GlaxoSmithKline

Scientific Title

A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

Eligibility

Inclusion

  • Participant must be more than or equal to (>=)18 years of age.
  • Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
  • Histological or cytological documentation of an advanced solid tumor.
  • Participants must provide a fresh biopsy.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • Adequate organ function per protocol specifications.
  • Male or female participants.
  • Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.
  • Capable of giving signed informed consent.

Exclusion

  • Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years.
  • Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment.
  • Current unstable liver or biliary disease.
  • History of vasculitis at any time prior to study treatment.
  • Evidence or history of significant active bleeding or coagulation disorder.
  • Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
  • QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block.
  • Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
  • Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
  • History or evidence of cardiovascular (CV) risk
  • Recent (within the past 6 months) history of symptomatic pericarditis.
  • History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
  • Prior treatment with the following agents:

    1. Stimulator of Interferon Genes (STING) agonist at any time.
    2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
    3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days.
    4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented.
  • Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed.
  • Receipt of any live vaccine within 30 days of the start of study treatment.
  • Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
  • Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
  • Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry.
  • Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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