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180 Participants NeededMy employer runs this trial

AZD4956 + Saruparib for Cancer

(PARTHENON Trial)

Recruiting at 14 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
Must not be taking: PARPi-based regimens
Disqualifiers: Uncontrolled medical condition, HIV, others
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?

The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumours with homologous recombination repair (HRR) deficiencies.

Are You a Good Fit for This Trial?

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

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

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