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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07115043

This Phase I/II open-label study evaluates the safety, pharmacokinetics, pharmacodynamics, and efficacy of AZD6750, a CD8 guided IL-2 agent, alone and with rilvegostomig in adults with advanced/metastatic solid tumors. Eligible participants are ≥18 years, with ECOG PS 0-1, measurable lesions, and adequate organ function. Specific criteria apply for select solid tumors and NSCLC stages.

Patient Parameters

Program Overview

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

Description

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

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

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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.

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

Locations

FACILITYZIPCITYSTATE
Research Site49546Grand RapidsMichigan
Research Site63110St LouisMissouri
Research Site15232PittsburghPennsylvania
Research Site77030HoustonTexas
Research Site78229San AntonioTexas
Research Site22031FairfaxVirginia

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