Recruiting PHASE1, PHASE2 Melanoma

Tests treatment safety and results for Melanoma

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

ClinicalTrials.gov ID: NCT07115043

What this study is testing

What is AZD6750?

AZD6750 is an investigational medicine, being studied as a potential treatment for melanoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join 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

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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
  • 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...
  • 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%.
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Grand Rapids, Michigan, United States
  • St Louis, Missouri, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • East Melbourne, Australia
  • Chūōku, Japan
  • Kashiwa, Japan
  • Seoul, South Korea

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Grand Rapids, Michigan, United States; St Louis, Missouri, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.