Study Overview

Study Details

Study overview

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

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

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

Research Site, Grand Rapids, Michigan, United States, 49546

Houston

Research Site, Houston, Texas, United States, 77030

San Antonio

Research Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Any evidence of:
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2029-04-09