Recruiting
Phase 1
Phase 2

AZD6750

Sponsor:

AstraZeneca

Code:

NCT07115043

Conditions

Melanoma

Non-small Cell Lung Cancer

Squamous Cell Carcinoma (Skin)

Renal Cell Carcinoma

Merkel Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD6750

rilvegostomig

Study Details

Brief summary:

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

Conditions

Melanoma

Non-small Cell Lung Cancer

Squamous Cell Carcinoma (Skin)

Renal Cell Carcinoma

Merkel Cell Carcinoma

Study ID

NCT07115043

Start date

Jul 29, 2025

Status verified date

Aug, 2026

Completion date

Oct 2, 2029

Anticipated

Primary completion date

Oct 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1

AZD6750 administered intravenously (IV) as a single agent

experimental: Module 2

AZD6750 given in combination with rilvegostomig (IV)

Interventions

AZD6750

AZD6750- CD8 guided IL-2

rilvegostomig

Rilvegostomig- PD1-TIGIT bispecific antibody

Primary outcome measure

  • Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion) [ Time Frame: Measured from the informed consent until Day 90 post-last dose. ]
  • Efficacy- Part 2B only (dose expansion) [ Time Frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Grand Rapids, Michigan, United States, 49546

Research Site

Recruiting

St Louis, Missouri, United States, 63110

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

San Antonio, Texas, United States, 78229

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AstraZeneca

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-19.