Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07115043

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Melanoma Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer/Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma High Grade Serous Ovarian Carcinoma Infections Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Merkel Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Polyomavirus Infections Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma (Skin) Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Cancer Triple Negative Breast Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, East Melbourne, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

<!-- -->

  • 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

Treatment and study plan

AZD6750

Drug

AZD6750- CD8 guided IL-2

Rilvegostomig

Drug

Rilvegostomig- PD1-TIGIT bispecific antibody

Primary outcomes

  1. 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.

    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

  2. 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)

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

Secondary outcomes

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

    Time frame: 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)

    To assess immunomodulatory biomarker PD-L1 at baseline and on treatment as a single agent and in combination with other anti-cancer agents as specified in each respective module

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

    Time frame: 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).

    To assess the incidence of anti-drug antibodies (ADA) against AZD6750 in serum and in combination with other anti-cancer agents as specified in each respective module

  3. Efficacy (Part 1A and 2A)

    Time frame: 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)

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

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

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

    To assess the plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule)

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

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

    To assess the Area Under Curve (AUC) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

  6. PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

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

    To assess the time to maximum plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

  7. PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

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

    To assess the clearance of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

  8. PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

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

    To assess the PK half-time of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 depending on Module/dosing schedule.

  9. PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)

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

    To assess the minimum observed concentration (Cmin) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.