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RecruitingPhase 1 / Phase 2

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

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 join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of AZD6750 in adults with certain solid tumors that have grown nearby or spread to other parts of the body. One part is for people with selected cancer types, and another is for people with stage IV non-small cell lung cancer.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old, weigh at least 35 kg (about 77 pounds), and be able to sign a form agreeing to join.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Provide a stored tumor tissue sample and have at least one tumor that can be measured using study rules.
  • Be expected to live at least 12 weeks.
  • Have stable heart function and good enough bone marrow, liver, and kidney function.
  • For Module 1: Have one of the selected solid tumor types that has grown nearby or spread, and have received suitable standard treatment.
  • For Module 2 dose testing: Have stage IV non-small cell lung cancer. You must either have had at least one treatment for cancer that has spread, including targeted treatment for treatable tumor gene changes if locally available, or have had no whole-body treatment and have a PD-L1 test result of at least 1%.
  • For Module 2 dose expansion: Have stage IV non-small cell lung cancer, no prior whole-body treatment, and a PD-L1 test result of at least 1%. PD-L1 is a protein measured in the tumor.

Who can't join

  • Have a severe or uncontrolled illness, including breathing, heart, or cancer-related problems; or have uncontrolled active or long-term hepatitis B or C infection.
  • Have had or plan to have an organ transplant or a stem cell transplant from another person.
  • Have had an autoimmune or inflammatory illness within the past 3 years, or need long-term medicine that weakens the immune system, including more than 10 mg of prednisone daily or a similar steroid dose. Autoimmune illness means the immune system attacks the body.
  • Had side effects that permanently stopped prior immune-based cancer treatment, or still have moderate or worse side effects from past cancer treatment.
  • Have cancer in the brain, unless it has been treated, is stable, causes no symptoms, and does not need ongoing steroids.
  • Have sudden untreated or symptom-causing pressure on the spinal cord from cancer, or have ever had cancer in the lining around the brain and spinal cord.
  • Have had severe lung inflammation not caused by infection, or received a vaccine containing a weakened live germ within 30 days.
  • For Module 2: Have had anti-TIGIT treatment, a type of immune-based treatment. People entering for their first treatment also cannot have a tumor gene change, such as EGFR, with a targeted drug available as standard first treatment locally.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (6)

MI

MO

PA

TX

VA