AZD7789 for Cancer

Recruiting at 22 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called AZD7789 that helps the immune system fight advanced solid tumors by blocking proteins that hide cancer cells. It aims to see if the medicine is safe and effective for patients whose cancer has progressed despite other treatments.

Eligibility Criteria

Adults with advanced or metastatic solid tumors, such as non-small cell lung cancer or stomach cancers, who have had prior treatments but not in the first-line setting. Participants must be able to provide a tumor tissue sample and meet certain health criteria like good organ function and performance status.

Inclusion Criteria

Your PD-L1 expression level is less than 1% or equal to or more than 1%.

I have had treatment before that included anti-PD-1/PD-L1 therapy.

My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.

Exclusion Criteria

My non-small cell lung cancer has specific genetic changes (EGFR mutations or ALK fusions).

My cancer has HER2 amplification and I haven't received standard HER2 therapy.

I have had a blood clot or heart attack in the last 6 months but am stable on medication.

Treatment Details

Interventions

• AZD7789 (Monoclonal Antibodies)

Trial Overview The trial is testing AZD7789, an experimental drug targeting PD-1 and TIM-3 pathways in cancer cells. It's for patients whose cancers haven't responded well to standard treatments. The study will check if this new treatment is safe and effective.

Participant Groups

Group I: Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 Experimental Treatment 1 Intervention

AZD7789 monotherapy

Group II: Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1 Experimental Treatment 1 Intervention

AZD7789 monotherapy

Group III: Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2 Experimental Treatment 1 Intervention

AZD7789 Monotherapy

Group IV: Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1 Experimental Treatment 1 Intervention

AZD7789 Monotherapy

Group V: Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1 Experimental Treatment 1 Intervention

AZD7789 Monotherapy

Group VI: Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance Experimental Treatment 1 Intervention

AZD7789 monotherapy

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology