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Clinical Trials in Japan / NCT07115043
Recruiting Phase 1/2

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

NCT07115043 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1/2
Started
2025-07-29
Last updated
2026-08-19

Condition(s) studied

MelanomaNon-small Cell Lung CancerSquamous Cell Carcinoma (Skin)Renal Cell CarcinomaMerkel Cell CarcinomaTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaGastric Cancer/Gastroesophageal Junction CancerHigh Grade Serous Ovarian Carcinoma

Investigational drug(s) / intervention(s)

AZD6750rilvegostomig →

AZD6750: AZD6750- CD8 guided IL-2

rilvegostomig: Rilvegostomig- PD1-TIGIT bispecific antibody

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Research Site Grand Rapids Michigan Recruiting
Research Site St Louis Missouri Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Houston Texas Recruiting
Research Site San Antonio Texas Recruiting
Research Site Fairfax Virginia Recruiting
Research Site East Melbourne Australia Recruiting
Research Site Chūōku Japan Recruiting
Research Site Kashiwa Japan Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Not Yet Recruiting
Research Site Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07115043 on ClinicalTrials.gov ↗ ← All trials in Japan