A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Study Identifier:
D7350C00001
CT.gov Identifier:
NCT07115043
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Renal
  • Merkel Cell Carcinoma
  • Breast Cancers
  • Head & Neck
  • Gastroesophageal
  • Ovarian
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Module 1
    • Read More
  • Drug: AZD6750 administered intravenously (IV) as a single agent
  • Drug: Drug: AZD6750
  • Drug: AZD6750- CD8 guided IL-2
  • Drug: EXPERIMENTAL: Module 2
  • Drug: AZD6750 given in combination with rilvegostomig (IV)
  • Drug: Drug: rilvegostomig
  • Drug: Rilvegostomig- PD1-TIGIT bispecific antibody
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Participant ≥ 18 year
    • * ECOG PS of 0 to 1
    • * Provision of 'archival' tumor specimen
    • * At least one measurable lesion according to RECIST v1.1,
    • * Minimum life expectancy of 12 weeks
    • * Adequate and stable cardiac function
    • * Adequate bone marrow, liver and kidney function
    • * Body weight ≥ 35 kg
    • * Capable of giving signed informed consent
    • Module 1 specific inclusion criteria:
    • • Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer/gastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC
    • Module 2 specific inclusion criteria:
    • * Participants with Stage IV NSCLC Dose Escalation/Backfills
    • 1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR
    • 2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
    • Dose Expansion
    • 1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
    Exclusion criteria
    • Any evidence of:
    • Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions
    • * History or planned organ or allogeneic stem cell transplantation.
    • * Active or prior documented autoimmune or inflammatory disorders, within the past 3 years
    • * Any prior toxicities that led to permanent discontinuation of prior immunotherapy
    • * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy
    • * Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids
    • * Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.
    • * Active uncontrolled or chronic infection of hepatitis B, hepatitis C
    • * Prior history of Grade ≥ 3 non-infectious pneumonitis.
    • * Participant requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
    • * Receipt of live attenuated vaccine within 30 days.
    • Module 2 specific exclusion criteria:
    • * Previous treatment with anti-TIGIT therapy
    • * 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Melanoma
    Non-Small Cell Lung Cancer
    Squamous Cell Carcinoma
    Renal
    Merkel Cell Carcinoma
    Breast Cancers
    Head & Neck
    Gastroesophageal
    Ovarian
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Melanoma
    Non-Small Cell Lung Cancer
    Squamous Cell Carcinoma
    Renal
    Merkel Cell Carcinoma
    Breast Cancers
    Head & Neck
    Gastroesophageal
    Ovarian