AZD3470 for Blood Cancer

(PRIMAVERA Trial)

Recruiting at 17 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: HIV, Active HBV/HCV, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, including systemic corticosteroids, you may not be eligible to participate.

What is the purpose of this trial?

This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

Eligibility Criteria

This trial is for adults with relapsed/refractory Hodgkin's or Non-Hodgkin's Lymphoma who've tried at least three treatments without success. They must have a measurable lymphoma lesion, good organ and bone marrow function, and be willing to use contraception. Excluded are those with severe medical conditions, active CNS lymphoma involvement, certain heart issues, uncontrolled infections like HIV/HBV/HCV, or prior treatment with MAT2A/PRMT5 inhibitors.

Inclusion Criteria

My organs and bone marrow are working well.

I am fully active or restricted in physically strenuous activity but can do light work.

I have a lymphoma lesion larger than 1.5 cm that can be seen on scans.

Exclusion Criteria

Known to have tested positive for HIV.

Serologic active HBV or HCV infection.

I have severe heart valve disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with relapsed/refractory classical Hodgkin Lymphoma (cHL) will take AZD3470 tablets orally until progression, unacceptable toxicity, or withdrawal of consent.

Approximately 6 months

Visits at predefined intervals throughout the treatment period

Dose Expansion/Optimization

Further characterization of the safety, PK, and preliminary efficacy of AZD3470 to support dose optimization.

Approximately 6 months

Visits at predefined intervals throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD3470

Trial Overview The study tests AZD3470 alone and combined with other cancer drugs in patients with blood cancers. It aims to assess the safety and initial effectiveness of oral AZD3470 doses. The trial has two parts: dose escalation (Part A) to find a safe dosage level and dose optimization/expansion (Part B) to further evaluate that dosage.

Participant Groups

Group I: Module 1: Part A (Dose Escalation) and Part B (Dose Expansion/Optimization) Experimental Treatment 1 Intervention

In Part A, participants with Relapsed/Refractory classical Hodgkin Lymphoma (cHL) will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent. In Part B, adult and adolescent participants with r/r cHL will take AZD3470 tablets orally until PD, unacceptable toxicity, or withdrawal of consent.

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