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

Study identifier:D7350C00001

ClinicalTrials.gov identifier:NCT07115043

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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

Medical condition

Melanoma, Squamous cell carcinoma (skin)

Phase

Phase 1/2

Healthy volunteers

Study drug

AZD6750, rilvegostomig

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 29 Jul 2025

Estimated Primary Completion Date: 09 Apr 2029

Estimated Study Completion Date: 09 Apr 2029

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2025 by AstraZeneca

Collaborators

Inclusion and exclusion 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
(a) 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
(b) Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Dose Expansion
(a) 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

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Module 1 AZD6750 administered intravenously (IV) as a single agent	Drug: AZD6750 AZD6750- CD8 guided IL-2
Experimental: Module 2 AZD6750 given in combination with rilvegostomig (IV)	Drug: AZD6750 AZD6750- CD8 guided IL-2 Drug: rilvegostomig Rilvegostomig- PD1-TIGIT bispecific antibody

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]