Saruparib for Cancer

KR
AT
Overseen ByAlex Torres
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests saruparib, a new drug type known as a PARP inhibitor, to evaluate its effectiveness on certain cancer tumors. Specifically, it targets tumors with a special marker called HRDsig, indicating a potential better response to this treatment. Individuals with advanced or metastatic solid tumor cancer, who have not shown resistance to platinum-based chemotherapy, might be suitable candidates. The trial aims to determine if saruparib can effectively target and shrink these tumors. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

Research has shown that saruparib, a PARP inhibitor, has been tested in various cancers, including breast and prostate cancer. One study on breast cancer patients with specific DNA issues found saruparib to be generally safe, with most patients tolerating the treatment well.

In another study involving 141 patients taking a 60 mg dose, some experienced side effects. Specifically, 92.2% of these patients reported side effects, but only 12.1% were severe. This indicates that while side effects are common, most are not serious.

Independent experts have reviewed saruparib's safety in other studies, which adds confidence in its safety profile. Overall, saruparib is generally well-tolerated, though it can cause side effects like many treatments.12345

Why do researchers think this study treatment might be promising?

Saruparib is unique because it works by inhibiting a protein called PARP, which plays a role in repairing damaged DNA in cancer cells. This mechanism makes it different from traditional chemotherapy, which attacks rapidly dividing cells indiscriminately. Researchers are excited about Saruparib because it targets cancer cells more precisely, potentially leading to fewer side effects and better effectiveness against certain types of cancer. Unlike some existing treatments, Saruparib could offer a more tailored approach, reducing harm to healthy cells and improving patient outcomes.

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

Studies have shown that saruparib, the investigational treatment tested in this trial, shows promise in treating cancer. Specifically, in breast cancer patients with certain DNA repair issues, about 48.4% experienced tumor shrinkage, meaning nearly half saw their tumors get smaller. Prostate cancer patients responded even better, with 88.5% seeing positive results. The drug also extended the period patients lived without their cancer worsening to about 9.1 months. These findings suggest that saruparib could effectively treat cancers with specific genetic traits.56789

Who Is on the Research Team?

KR

Kim Reiss Binder, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

This trial is for people with solid tumors that test positive for a specific genetic signature called HRDsig, as determined by the FoundationOne®CDx test. Participants must have cancer and meet other medical requirements set by the study.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.
My tumor tested positive for HRD using the Foundation Medicine test.
I have a confirmed mutation in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D, or BARD1.
See 7 more

Exclusion Criteria

Any condition increasing risk or interfering with study participation or results per investigator judgment
Participants with INR >2
Expected life expectancy <12 weeks
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive saruparib, an experimental PARP inhibitor, for the treatment of HRDsig+ solid tumors

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Saruparib

Trial Overview

The study is testing saruparib, an experimental drug known as a PARP inhibitor, in patients whose tumors are HRDsig-positive. The FoundationOne®CDx test is used to identify eligible participants.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Saruparib (AZD5305)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials
425
Recruited
464,000+

AstraZeneca

Industry 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

Basser Center for BRCA

Collaborator

Trials
2
Recruited
620+

Citations

Next-generation PARP Inhibitor Demonstrates Clinical ...

Among the 31 breast cancer patients treated with 60 mg saruparib, the objective response rate was 48.4%, the median duration of response was 7. ...

Saruparib Appears Safe, Active in Advanced Breast Cancer

The median progression-free survival (PFS) was 4.6 months with the 20 mg dose and 9.1 months with the 60 mg dose. PFS data were not available ...

Selective PARP1 Inhibitor Shows Early Efficacy in HRR- ...

Saruparib at 60 mg demonstrated deep and durable responses. ORR was 48.4%, and median PFS was 9.1 months, which was favorable compared with the ...

The PARP1 selective inhibitor saruparib (AZD5305 ... - PMC

AZD5305 showed superior antitumor activity than the first-generation PARPi in terms of preclinical complete response rate (75% vs. 37%).

PARP1-selective inhibitor demonstrates early efficacy in ...

The objective response rate was 48.8% with a median progression-free survival of 9.1 months. The drug had favorable tolerability as well as ...

Phase III, randomized, double-blind, placebo-controlled ...

The Phase III EvoPAR-Prostate02 study (NCT06952803) is evaluating the efficacy and safety of adjuvant saruparib versus placebo in patients with ...

Saruparib for Prostate Cancer (EvoPAR-PR02 Trial)

Research shows that Saruparib has been tested for its effects and safety in people with advanced prostate cancer. In earlier studies, Saruparib showed promising ...

NCT06120491 | Saruparib (AZD5305) vs Placebo in Men ...

Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + ...

AZD5305 (Saruparib) Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of saruparib (AZD5305) across various oncology indications, including advanced breast cancer, ...