A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    81
  • sponsor
    AstraZeneca
Updated on 23 July 2022
systemic therapy
measurable disease
carcinoma
lung carcinoma

Summary

This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.

Description

This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment AZD7789
Clinical Study IdentifierNCT04931654
SponsorAstraZeneca
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be ≥ 18 years of age
Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation
Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Provision of archival or fresh tumor tissue sample and/or consent to undergo mandatory on-treatment biopsy for participants enrolled in Part A Dose-escalation
Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose-expansion participants
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
Adequate organ and bone marrow function measured within 28 days prior to first dose
Part A Dose Escalation Additional Inclusion Criteria
May have squamous or non-squamous NSCLC
Must have received at least one prior line of systemic therapy, of which at least one prior line of therapy contained approved anti-PD-1/PD-L1
Must have had immune-oncology (IO) acquired or primary resistance
PD-L1 expression < 1% or ≥ 1% documented
Part B Dose Expansion Cohort B1 Additional Inclusion Criteria
May have squamous or non-squamous NSCLC
Must have received at least one but no more than 2 prior lines of systemic therapy, of which only one prior line of therapy contained approved anti-PD-1/PD-L1
Must have had IO acquired resistance
PD- L1 TPS ≥ 1% documented
Part B Dose Expansion Cohort B2 Additional Inclusion Criteria
May have squamous or non-squamous NSCLC
Must not have received prior systemic therapy including IO therapy in the first-line setting
PD-L1 TPS ≥ 50% documented

Exclusion Criteria

Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions
Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC)
Unresolved toxicities of ≥ Grade 2 from prior therapy
Any prior ≥ Grade 3 immune-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE ≥ Grade 2
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
History of symptomatic and objectively confirmed arterial (including myocardial infarction) or venous thromboembolic event within 6 months prior to the first dose of study intervention
History of organ transplant or allogenic haematopoietic stem cell transplant
Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
History of arrhythmia which is symptomatic or requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non infectious skin disease
Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Major surgical procedure within 28 days prior to the first dose of study intervention or still recovering from prior surgery
Other invasive malignancy within 2 years prior to screening
Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
Previous treatment with anti-TIM-3 therapy in any setting
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable
Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants should not receive live vaccine while receiving study intervention and up to 30 days after the last dose of study intervention
Radiotherapy treatment to the lung within ≤ 4 weeks of the first dose of AZD7789. Palliative bone radiotherapy is allowed if ≥ 2 weeks prior to the first dose of AZD7789
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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