180 Participants NeededMy employer runs this trial

AZD4956 + Saruparib for Cancer

(PARTHENON Trial)

Recruiting at 15 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer treatment by testing different doses of a drug called AZD4956, both alone and in combination with saruparib (a type of cancer therapy), to assess their safety and effectiveness. It targets individuals with advanced or metastatic solid tumors, particularly those with specific genetic vulnerabilities in their cancers. Those with advanced breast, ovarian, or prostate cancer who have not received certain other treatments might be suitable candidates. As a Phase 1 trial, the research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating AZD4956 as a single treatment to determine its safety and tolerability in patients with advanced or spreading solid tumors. Since AZD4956 remains in the early stages of human testing, researchers are still gathering and studying detailed safety information.

When combined with saruparib, studies are assessing how well patients tolerate this treatment. Early results indicate that researchers are monitoring for side effects, though specific details are not yet fully available. This combination targets tumors with certain genetic traits, making safety understanding crucial.

For saruparib alone, evidence suggests it is generally well-tolerated. Reports indicate that saruparib is safe with a wide range between effective and harmful doses. However, like many treatments, it can cause side effects such as tiredness and nausea.

Overall, while researchers continue to study the safety of these treatments, the trials are designed to closely monitor participants for any side effects to ensure their safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD4956 and saruparib because these treatments offer a novel approach to cancer therapy. Unlike traditional chemotherapy that attacks all rapidly dividing cells, AZD4956 is being explored for its potential to precisely target cancer cells while sparing healthy ones. Saruparib, on the other hand, is a promising PARP inhibitor, which interferes with cancer cells' ability to repair their DNA, making them more vulnerable to damage. This combination is particularly intriguing as it could enhance the effectiveness of treatment by using two complementary mechanisms, potentially leading to better outcomes for patients with fewer side effects.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will evaluate AZD4956 and saruparib in different treatment arms. Studies have shown that AZD4956 targets tumors with specific genetic defects common in some cancers. This approach exploits the cancer cells' inability to repair DNA properly, potentially stopping their growth. In this trial, some participants will receive AZD4956 as monotherapy, while others will receive it combined with saruparib. Research indicates that combining AZD4956 with saruparib, a drug that has shown promising results in prostate and breast cancers, might enhance effectiveness. Studies on saruparib alone have demonstrated its efficacy in patients with advanced cancers, with nearly half responding positively. These findings suggest that using AZD4956 and saruparib together could effectively treat cancers with these genetic defects.46789

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like breast, ovarian, prostate, pancreatic cancers) that have a specific DNA repair problem. Participants must have disease progression, be in good physical condition, and have adequate organ function. People with certain infections or bleeding risks can't join.

Inclusion Criteria

Minimum life expectancy ≥ 12 weeks
I have a solid tumor cancer that is locally advanced or has spread.
My disease has gotten worse or progressed.
See 14 more

Exclusion Criteria

I have a condition that makes me more likely to bleed.
I have received an organ transplant from a donor.
I do not have any serious or uncontrolled health problems.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment - Module 1 Part A

Participants receive AZD4956 as monotherapy at ascending dose levels for dose escalation and finding

Up to 28 days

Treatment - Module 2 Part A

Participants receive AZD4956 in combination with saruparib at ascending dose levels for dose escalation

Up to 28 days

Treatment - Module 2 Part B

Participants receive AZD4956 in combination with saruparib for dose expansion to evaluate safety and preliminary efficacy

Up to 3.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Saruparib

Trial Overview

The study tests AZD4956 alone and combined with another anti-cancer drug called Saruparib in people with these cancers. The main goal is to find safe dose levels and see how the drugs affect the body and cancer growth.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Module 2 Part B: AZD4956 + saruparib (Dose expansion)Experimental Treatment2 Interventions
Group II: Module 2 Part A: AZD4956 + saruparib (Dose escalation)Experimental Treatment2 Interventions
Group III: Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparibExperimental Treatment2 Interventions
Group IV: Module 2 Part A Optional PD backfill cohort: Saruparib monotherapyExperimental Treatment1 Intervention
Group V: Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparibExperimental Treatment2 Interventions
Group VI: Module 1 Part A: AZD4956 monotherapy (Dose escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

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

NCT07446855 | Study of AZD4956 as Monotherapy and in ...

To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s). Up to 28 days. Secondary Outcome Measures ...

AZD4956 + Saruparib for Cancer (PARTHENON Trial)

Participants receive AZD4956 in combination with saruparib for dose expansion to evaluate safety and preliminary efficacy. Up to 3.5 years.

Clinical Trials Appendix - Q1 2026 Results Update

• Module 2: AZD4956 + saruparib. • Each module may further contain ... Big Ten Cancer Research Consortium. BM. Biomarker. BMD. Bone mineral ...

AZD-4956 - Drug Targets, Indications, Patents

Clinical Results associated with AZD-4956. Login to view more data. 100 Translational Medicine associated with AZD-4956. Login to view more data.

AstraZeneca Expands DNA-Repair Oncology Pipeline With ...

The main treatment is AZD4956, an oral drug designed to target tumours with homologous recombination repair defects. It is tested alone and ...

Study of AZD4956 as Monotherapy and in Combination ...

- Part B (dose expansion): To further evaluate the safety and preliminary efficacy of AZD4956 in combination with other anti-cancer agents.

Study of AZD4956 as Monotherapy and in Combination ...

To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s). From Screening (Day -28) to follow-up (up to 3.5 ...

Study of AZD4956 as Monotherapy and in... | Clinical Trial

To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s). Part B: Progression free survival ( ...

A Modular Open-label, Phase I/IIa Study to Assess the Safety ...

Drugs AZD 4956 (Primary) ; Saruparib · Indications Adenocarcinoma; Breast cancer; Fallopian tube cancer; Male breast cancer; Ovarian cancer; Pancreatic cancer; ...