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

NCT07115043 | Recruiting Phase 1 FDA Drug

• 1 other identifier: D7350C00001
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 11

Brief Summary

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

Conditions

Triple Negative Breast Cancer; Head and Neck Squamous Cell Carcinoma; High Grade Serous Ovarian Carcinoma; Renal Cell Carcinoma; Merkel Cell Carcinoma; Squamous Cell Carcinoma (Skin); Melanoma; Non-small Cell Lung Cancer; Gastric Cancer/Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (2)

• Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)

  To assess the safety and tolerability, characterize the DLTs, and determine the MTD and RP2D(s) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module

  Measured from the informed consent until Day 90 post-last dose.

• Efficacy- Part 2B only (dose expansion)

  To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.

  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)

Secondary Outcomes (9)

• Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)

  Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule)

• Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)

  Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).

• Efficacy (Part 1A and 2A)

  Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years)

• PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

  Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals

• PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

  Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals

Study Arms (2)

Module 1

EXPERIMENTAL

AZD6750 administered intravenously (IV) as a single agent

Drug: AZD6750

Module 2

EXPERIMENTAL

AZD6750 given in combination with rilvegostomig (IV)

Drug: AZD6750; Drug: rilvegostomig

Interventions

AZD6750 DRUG

AZD6750- CD8 guided IL-2

Module 1; Module 2

rilvegostomig DRUG

Rilvegostomig- PD1-TIGIT bispecific antibody

Module 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Participants with Stage IV NSCLC Dose Escalation/Backfills
• 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
• Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
• Dose Expansion
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You may not qualify if:

• 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.
• Previous treatment with anti-TIGIT therapy
• L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (11)

Research Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

Research Site

St Louis, Missouri, 63110, United States

RECRUITING

Research Site

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

San Antonio, Texas, 78229, United States

RECRUITING

Research Site

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site

East Melbourne, 3002, Australia

RECRUITING

Research Site

Chūōku, 104-0045, Japan

RECRUITING

Research Site

Kashiwa, 227-8577, Japan

RECRUITING

Research Site

Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Renal Cell; Carcinoma, Merkel Cell; Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Breast Neoplasms; Breast Diseases; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Module 1 consists of treatment with AZD6750 administered as a single agent to enroll participants with select locally advanced or metastatic solid tumors who have received prior adequate SoC. Select solid tumors include the tumor types known to show activity with ICIs (either as a single agent or in combination with other anti-cancer agents) or include reports potentially showing benefit of IL-2. Module 1 will consist of Part 1A (dose escalation). The combination arm (Module 2) will open on agreement with SRC, and will investigate AZD6750 and rilvegostomig, enrolling participants with Stage IV NSCLC who either received at least one line of therapy in metastatic setting or are treatment naïve in metastatic setting and have a PD-L1 expression ≥ 1%. Module 2 will consist of an escalation arm (Module 2A) and an expansion arm (Module 2B). Dose expansion (Module 2B) may open further to characterize preliminary efficacy of AZD6750 in combination with rilvegostomig.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 11, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): October 2, 2029
• Study Completion (Estimated): October 2, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

AU (1); JP (2); US (6); KR (2)