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

NCT ID: NCT07115043

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2029-10-02

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Module 1

AZD6750 administered intravenously (IV) as a single agent

Group Type EXPERIMENTAL

AZD6750

Intervention Type DRUG

AZD6750- CD8 guided IL-2

Module 2

AZD6750 given in combination with rilvegostomig (IV)

Group Type EXPERIMENTAL

AZD6750

Intervention Type DRUG

AZD6750- CD8 guided IL-2

rilvegostomig

Intervention Type DRUG

Rilvegostomig- PD1-TIGIT bispecific antibody

Interventions

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AZD6750

AZD6750- CD8 guided IL-2

Intervention Type DRUG

rilvegostomig

Rilvegostomig- PD1-TIGIT bispecific antibody

Intervention Type DRUG

Eligibility Criteria

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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


• 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

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.


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Grand Rapids, Michigan, United States

Site Status RECRUITING

Research Site

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Research Site

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status NOT_YET_RECRUITING

Research Site

East Melbourne, , Australia

Site Status RECRUITING

Research Site

Chūōku, , Japan

Site Status RECRUITING

Research Site

Kashiwa, , Japan

Site Status RECRUITING

Countries

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United States Australia Japan

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D7350C00001

Identifier Type: -

Identifier Source: org_study_id