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

Launched by ASTRAZENECA · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is testing the safety of a new medicine called AZD6750 in adults who have certain advanced or spreading types of solid tumors, such as melanoma (a type of skin cancer), lung cancer, breast cancer, and several others. The study is in its early phase, which means the main goal is to see if the medicine is safe to use and to understand how the body handles it.

Adults aged 18 and older with specific kinds of advanced cancers who have measurable tumors and are generally healthy enough (meaning their heart, liver, kidneys, and bone marrow are working well) may be eligible to join. Participants should have already tried standard treatments for their cancer or meet certain criteria based on their tumor type and previous treatments. During the trial, participants will be closely monitored to check for any side effects and to learn how the drug affects their cancer. It’s important to note that people with certain health issues, like active infections or severe immune system problems, may not be able to take part. This study is not yet open for enrollment but aims to help find new options for people with difficult-to-treat cancers.

Gender

ALL

Eligibility 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
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• • 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