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Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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.
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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07115043
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Japan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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

Arms & Interventions

Arms

Experimental: Module 1

AZD6750 administered intravenously (IV) as a single agent

Experimental: Module 2

AZD6750 given in combination with rilvegostomig (IV)

Interventions

Drug: - AZD6750

AZD6750- CD8 guided IL-2

Drug: - rilvegostomig

Rilvegostomig- PD1-TIGIT bispecific antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

Research Site

Grand Rapids 4994358, Michigan 5001836, 49546

Site Contact

[email protected]

1-877-240-9479

Research Site, Houston 4699066, Texas 4736286

Status

Not yet recruiting

Address

Research Site

Houston 4699066, Texas 4736286, 77030

Site Contact

[email protected]

1-877-240-9479

Research Site, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

Research Site

San Antonio 4726206, Texas 4736286, 78229

Site Contact

[email protected]

1-877-240-9479

International Sites

Research Site, East Melbourne 6952201, Australia

Status

Recruiting

Address

Research Site

East Melbourne 6952201, , 3002

Site Contact

[email protected]

1-877-240-9479

Research Site, Chūōku 10262791, Japan

Status

Not yet recruiting

Address

Research Site

Chūōku 10262791, , 104-0045

Site Contact

[email protected]

1-877-240-9479

Research Site, Kashiwa 1859924, Japan

Status

Not yet recruiting

Address

Research Site

Kashiwa 1859924, , 227-8577

Site Contact

[email protected]

1-877-240-9479

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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