Testing AZD6750 safety in adults with selected advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1/2 study uses a dose-escalation and expansion design to define the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD6750 alone and in combination with other anti-cancer agents. Participants must have selected advanced or metastatic solid tumors and meet standard eligibility requirements such as ECOG 0–1, measurable disease per RECIST v1.1, and adequate organ function. The trial includes collection of archival tumor tissue and serial safety and biomarker assessments to guide dose selection and expansion cohorts. Sites for enrollment are in the United States and the sponsor is AstraZeneca.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Grand Rapids, Michigan, United States Recruiting
• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  Pittsburgh, Pennsylvania, United States Recruiting
• Research Site
  Houston, Texas, United States Recruiting
• Research Site
  San Antonio, Texas, United States Recruiting
• Research Site
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.