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Malignant Neoplastic Disease (Disorder)Phase 2NCT07832630

Saruparib in HRDsig+ Solid Tumors

A Phase 2 study testing Saruparib and FoundationOne®CDx in people with Malignant Neoplastic Disease (Disorder), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The main purpose of this study is to study the effect of saruparib, an experimental PARP inhibitor, on tumors that have an Homologous Recombination Deficiency Signature (HRDsig) positive tumor by the investigational FoundationOne®CDx clinical trial assay. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplastic Disease (Disorder)
What is being tested?
Saruparib and FoundationOne®CDx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 1 Nov 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology (ECOG) performance status of 0 to 1
  • Diagnosis of a metastatic or locally advanced solid tumor malignancy for which no cure is considered possible.
  • Patients with breast, ovarian, prostate or pancreatic cancer may not enroll within Cohort A
  • Patients with ovarian cancer may not enroll in Cohort B
  • No history of resistance to platinum therapy, defined as disease progression within six months of exposure to platinum chemotherapy (ie cisplatin, oxaliplatin, carboplatin). Patients may be platinum-naïve at time of enrollment.
  • Progressing at time of enrollment
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  • Measurable disease
  • Tumor is HRDsig+ by Foundation Medicine Inc assay
  • Patients in Cohort A must also have a documented pathogenic germline or somatic variant in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D or BARD1 as assessed by a CLIA certified laboratory (this can be done at any time prior to enrollment via tissue assay). Central review of variants must be performed by PI prior to patient enrollment.
  • Adequate organ function confirmed by the following laboratory values obtained during the screening period:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 10g/dL
  • ALT and AST ≤2.5×ULN; for participants with hepatic metastases, ALT and AST ≤5×ULN
  • Total bilirubin ≤ 1.5x ULN. If liver metastases or metabolic disorder such as Gilbert's Syndrome, then ≤2.5x ULN
  • eGFR of ≥ 45 mL/min/1.73m2 as determined by CKD-EPI formula (Inker et al 2021).
  • For male participants with SCr ≤ 0.9 mg/dL, use the following formula:
  • 142 x (SCr/0.9)-0.302 x 0.9938Age (years)
  • For male participants with SCr > 0.9 mg/dL, use the following formula:
  • 142 x (SCr/0.9)-1.200 x 0. 9938Age (years)
  • For female participants with SCr < 0.7 mg/dL, use the following formula:
  • 142 x (SCr/0.7)-0.241 x 0.9938Age (years) x 1.012
  • For female participants with SCr > 0.7 mg/dL, use the following formula:
  • 142 x (SCr/0.7)-1.200 x 0.9938Age (years) x 1.012

Who cannot join

  • Reversion variant in the peripheral blood as assessed by a CLIA certified local assay (Cohort A only)
  • Prior exposure to PARP inhibition
  • Evidence of platinum-resistance, defined as disease progression within six months of exposure to a platinum chemotherapy (ie cisplatin, oxaliplatin, carboplatin)
  • Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal disorder or defect that would in the opinion of the investigator, interfere with absorption of saruparib
  • Acute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 7 days prior to first dose of saruparib
  • Participants with INR >2 or higher
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  • Evidence of active and uncontrolled hepatitis B and/or hepatitis C. Screening for hepatitis B and hepatitis C is not required. Participants previously exposed to hepatitis B or hepatitis C are eligible if they meet one of the following criteria:
  • Are negative for HBsAg and anti-HBc; or b. Are HBsAg+ and anti-HBc+ (chronic hepatitis B), and meet conditions i to iii below: i. HBV DNA viral load < 2000 IU/mL. ii. Have normal aminotransferase values. iii. Start antiviral treatment at least 2 weeks prior to the first dose of study intervention and maintain antiviral treatment during the interventional period.
  • Are anti-HBc positive, HBsAg negative, and have HBV DNA < 2000 IU/mL. d. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Evidence of active and uncontrolled HIV infection. Participants with controlled HIV need to meet the following criteria: undetectable viral RNA load less than 400 copies/mL in the last 4 weeks prior to first dose of study intervention, CD4+ count of ≥ 350 cells/μL, no history of AIDS-defining opportunistic infection within the past 12 months, and stable on the same anti-HIV medications. Screening for HIV is not required.
  • Symptomatic or untreated CNS metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. Corticosteroid dose should not exceed 10mg/day of prednisone or its equivalent
  • Expected life expectancy of <12 weeks as determined by the investigator
  • For fertile patient (female patient able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial
  • Received any systemic treatment for their advanced malignancy 3 weeks prior to first dose of saruparib
  • Active drug or alcohol use or dependence that would interfere with study adherence
  • Presence of any other condition that may increase the risk associated with study participation or may interfere with interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.
  • Participant meets one or more of the following:
  • Mean resting corrected QT interval >470 ms, obtained from triplicate ECGs performed at screening.
  • History of QT prolongation associated with other medications that required discontinuation of that medication.
  • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
  • History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted based on the Investigator judgement with cardiologist consultation recommended.
  • Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir). The required washout period prior to starting study treatment is 2 weeks.
  • Concomitant use of known strong CYP3A4 inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia and grade 2 prior platinum-therapy-related neuropathy.
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • History of persisting (> 2 weeks) severe pancytopenia due to any cause (eg, ANC < 0.5 x 109 /L or platelets < 50 x 109 /L)
  • As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases including but not limited to uncontrolled hypertension, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, renal transplant, active bleeding diseases, superior vena cava syndrome, extensive interstitial bilateral lung disease which, in the investigator's opinion, makes it undesirable for the subject to participate in the study or that would jeopardise compliance with the protocol.
  • Major surgery (excluding local surgery of isolated lesions for palliative treatment or diagnostic staging) within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery or an anticipated need for major surgery during the study.
  • Participation in another clinical study with exposure to an investigational product within 30 days or five half-lives (whichever is the longer) prior to initiating study treatment
  • Patients with a known hypersensitivity to saruparib or any of the excipients of the product.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kim Reiss Binder, MD contact

215-360-0735

Kim.ReissBinder@pennmedicine.upenn.edu

Alex Torres contact

267-496-7621

Alexandra.Torres@Pennmedicine.upenn.edu

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Kim Reiss Binder, MD, 215-360-0735, Kim.ReissBinder@pennmedicine.upenn.edu

    Alex Torres, 267-496-7621, Alexandra.Torres@Pennmedicine.upenn.edu

Other trials in United States

About this study

Official title: A Phase II Study of Saruparib in Patients With Platinum-Sensitive, HRDsig+ Solid Tumors

The main purpose of this study is to study the effect of saruparib, an experimental PARP inhibitor, on tumors that have an Homologous Recombination Deficiency Signature (HRDsig) positive tumor by the investigational FoundationOne®CDx clinical trial assay.

Read the detailed description

This is an open-label, phase II study of saruparib in patients with locally advanced or metastatic solid tumors that are HRDsig+ by FoundationOneCDx (Foundation Medicine, Inc). Patients in Cohort A must also have a pathogenic germline or somatic variant in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D or BARD1. The primary endpoint is overall response rate in Cohort A.

Being tested
Saruparib, FoundationOne®CDx
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaruparibDrug

    Saruparib (AZD5305) 60mg PO daily

  • FoundationOne®CDxDiagnostic test

    Tumors will be tested for positive HRDsig tumor by the investigational FoundationOne®CDx clinical trial assay.

Study groups in NCT07832630
Study groupRoleWhat they receive
Saruparib (AZD5305)ExperimentalSaruparib
Receives: Drug: Saruparib; Diagnostic Test: FoundationOne®CDx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best objective response as determined by RECIST v.1.1

    Best objective response as assessed by the Investigator per RECIST 1.1

    Measured: From baseline through documented disease progression (RECIST v1.1) or death from any cause, whichever occurs first, up to 2 years.

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS, as assessed by the Investigator per RECIST 1.1

    Measured: From first dose of saruparib until documented disease progression (RECIST v1.1) or death from any cause, whichever occurs first, up to 2 years.

  2. Overall survival

    Overall survival, as assessed by the Investigator per RECIST 1.1

    Measured: From first dose of saruparib until death from any cause, up to 2 years.

  3. Duration of response (DOR)

    DOR as assessed by the Investigator

    Measured: From first documented complete or partial response until disease progression or death, up to 2 years.

  4. Disease control rate (DCR)

    DCR is defined as the proportion of patients who achieve CR, PR, or SD by RECIST v1.1.

    Measured: Percentage of participants achieving complete response, partial response, or stable disease per RECIST v1.1, assessed up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832630
Sponsor's protocol ID
UPCC 09926
Other IDs
26-6759
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: All IPD that underlie results in publication.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saruparib and FoundationOne®CDx in people with Malignant Neoplastic Disease (Disorder), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kim Reiss Binder, MD (215-360-0735, Kim.ReissBinder@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best objective response as determined by RECIST v.1.1 (time frame: From baseline through documented disease progression (RECIST v1.1) or death from any cause, whichever occurs first, up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07832630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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