AZD3470 for Blood Cancer

(PRIMAVERA Trial)

Recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, AZD3470, for individuals with classical Hodgkin Lymphoma (cHL) that hasn't responded to other treatments. The primary goal is to determine if AZD3470 is safe and effective alone or in combination with other cancer drugs. The trial seeks participants with active cHL who have tried at least three other treatment options without success. Participants must have a measurable cancer lesion and must have completed all available therapies with known benefits. As a Phase 1 trial, this research aims to understand how AZD3470 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AZD3470 is likely to be safe for humans?

Research shows that AZD3470, a new drug, is being tested to treat blood cancers. AZD3470 is promising because it targets cancer cells while leaving normal cells unharmed, potentially causing fewer side effects. Studies are examining AZD3470 both alone and in combination with other cancer treatments.

Since AZD3470 is still in early testing stages, detailed safety information remains limited. Early trials typically focus on assessing the drug's safety and determining the right dose. While there is hope that it is well-tolerated, researchers are still learning about all possible side effects. As testing progresses, researchers will gather more information about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for relapsed/refractory classical Hodgkin Lymphoma (cHL), which often include chemotherapy and immunotherapy, AZD3470 is an oral tablet offering a potentially less invasive and more convenient option. Researchers are excited about AZD3470 because it may work by targeting specific pathways associated with cancer cell growth, potentially offering a new mechanism of action compared to existing treatments. This targeted approach could lead to more effective management of the disease with possibly fewer side effects.

What evidence suggests that AZD3470 might be an effective treatment for blood cancer?

Research has shown that AZD3470 could be a promising treatment for blood cancers, such as relapsed or hard-to-treat classical Hodgkin Lymphoma (cHL). This trial tests AZD3470 in two parts: Part A focuses on dose escalation, and Part B on dose expansion and optimization. Early results indicate that AZD3470 targets a specific protein in cancer cells, potentially stopping cancer growth. Initial findings suggest effectiveness, but further research is necessary to confirm this. Patients in ongoing trials contribute to understanding its efficacy and safety. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06137144

Study Details | NCT06137144 | AZD3470 as Monotherapy ... This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in ...

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9971C00001

AZD3470 as Monotherapy and in Combination With ... This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in ...

3. clinicaltrials.eu clinicaltrials.eu/inn/azd3470/

AZD3470: A Promising New Drug for Cancer Treatment AZD3470 is a novel drug currently being studied in clinical trials for its potential in treating advanced solid tumors and hematologic malignancies.

4. vjhemonc.com vjhemonc.com/video/a9bgm3dxid0-the-phase-iii-primavera-study-evaluating-azd3470-in-rr-hematological-malignancies/

ICML 2025 | The Phase I/II PRIMAVERA study evaluating ... Prof. Derenzini notes that the ongoing trial aims to assess the safety and efficacy of AZD3470, with results to be presented at future meetings.

5. researchgate.net researchgate.net/publication/386463546_PRIMAVERA_A_Modular_Phase_III_Study_to_Evaluate_the_Safety_Tolerability_and_Efficacy_of_AZD3470_a_Protein_Arginine_Methyltransferase_5_PRMT5_Inhibitor_in_Participants_with_RelapsedRefractory_Hematolog

PRIMAVERA: A Modular Phase I/II Study to Evaluate the ... Here, we describe a phase I/II trial designed to assess AZD3470 as monotherapy and in combination with anticancer agents in participants with ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124091985

PRIMAVERA: A Modular Phase I/II Study to Evaluate the ... AZD3470 is an MTA-cooperative PRMT5 inhibitor that preferentially targets the MTA-bound state of PRMT5, sparing its inhibition in normal cells.

7. withpower.com withpower.com/trial/phase-2-lymphoma-10-2023-958b4

AZD3470 for Blood Cancer (PRIMAVERA Trial) This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, ...