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NCT07115043 | RECRUITING | Melanoma

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

AstraZeneca

Brief Summary:

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

Condition or disease

Melanoma

Non-small Cell Lung Cancer

Squamous Cell Carcinoma (Skin)

Renal Cell Carcinoma

Merkel Cell Carcinoma

Triple Negative Breast Cancer

Head and Neck Squamous Cell Carcinoma

Gastric Cancer/Gastroesophageal Junction Cancer

High Grade Serous Ovarian Carcinoma

Intervention/treatment

AZD6750

rilvegostomig

Phase

PHASE1

PHASE2

Detailed Description:

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 Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-07-29
Estimated Primary Completion Date : 2029-10-02
Estimated Study Completion Date : 2029-10-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

Location Details

NCT07115043

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, road cancer

Research Site

Grand Rapids, road cancer, United States, 49546

NOT YET RECRUITING

United States, Missouri

Research Site

St Louis, Missouri, United States, 63110

NOT YET RECRUITING

United States, Pennsylvania

Research Site

Pittsburgh, Pennsylvania, United States, 15232

NOT YET RECRUITING

United States, Texas

Research Site

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Research Site

Saint Anthony, Texas, United States, 78229

NOT YET RECRUITING

United States, Virginia

Research Site

Fairfax, Virginia, United States, 22031

RECRUITING

Australia,

Research Site

East Melbourne, Australia, 3002

NOT YET RECRUITING

Japan,

Research Site

Chūoku, Japan, 104-0045

NOT YET RECRUITING

Japan,

Research Site

Kashiwa, Japan, 227-8577