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HER2-negative Metastatic Breast CancerPhase 1NCT05261269

A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

A Phase 1 study testing DAN-222 and Niraparib in people with HER2-negative Metastatic Breast Cancer, run by Dantari, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: Part A is dose escalation of single agent DAN-222 Part B is dose escalation of DAN-222 in combination with… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER2-negative Metastatic Breast Cancer
What is being tested?
DAN-222 and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
9 sitesUnited States
Study dates
2 Feb 2022to 11 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically documented, metastatic, HER2-negative breast cancer that has progressed after two prior lines of therapy (including adjuvant therapy if progressed within the last 12 months, and aromatase inhibitors will be considered a line of therapy). Subjects with HR+ disease can have prior CDK4/6 inhibitors and subjects with BRCAm disease may have prior PARPi therapy. HER2 positivity is defined by standard of care fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistory (IHC) according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Clinical Practice Guideline Focused Update.
  • A minimum of 2 weeks or 5 half-lives (whichever is longer) will be required from any prior therapy for mBC, including chemotherapy, immunotherapy and/or radiation therapy.
  • Subjects must have measurable disease as per RECIST v1.1.
  • Females, age 18 years or older.
  • ECOG performance status ≤ 2.
  • Subjects with previously treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 4 weeks and the subject is off steroids for at least 7 days prior to first dose of study treatment, and any neurologic symptoms have returned to baseline (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT scan).
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  • Subjects with brain metastases should not require use of enzyme-inducing antiepileptic drugs (eg, carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose of study treatment and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions is allowed.
  • Subjects must have normal organ and marrow function as defined below:
  • absolute neutrophil count ≥ 1.5 x 109/L without growth factor support in the last 7 days
  • platelets ≥ 100 x 109/L without growth factor support in the last 7 days
  • hemoglobin ≥ 9 g/dL and no blood transfusion within 4 weeks
  • total bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless Gilbert's Disease)
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
  • creatinine clearance ≥ 60 mL/min (calculated using the Cockroft-Gault formula) for subjects with creatinine levels above institutional normal
  • Patients of childbearing potential have a negative serum pregnancy test within 72 hours prior to the first dose of study medication. Non-childbearing potential is defined as (by other than medical reasons):
  • 45 years of age or older and has not had menses for > 1 year
  • Amenorrheic at least 2 years without a hysterectomy and oophorectomy and a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation
  • Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the subject must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study therapy.
  • Subject is willing and able to comply with the protocol for the duration of the study including providing medical information, study examinations or tests at scheduled visits and study treatment.

Who cannot join

  • Any significant medical condition or laboratory abnormalities which place the subject at unacceptable risk if he/she were to participate in the study at clinician's discretion and not otherwise stated below.
  • For the DAN-222 and niraparib combination cohorts, subjects cannot have known sensitivity to FD\&C Yellow No. 5 (tartrazine).
  • Allergic reaction to irinotecan, topotecan, or govitecan.
  • Concurrent administration or received cytochrome P450 3A4 (CYP3A4) enzyme inducers or inhibitors within 2 weeks prior to the first day of study treatment.
  • Subjects taking medications know to prolong the QT interval or associated with torsades de pointes, unless the subject can safely discontinue these medications or change to comparable medications that do not significantly prolong the QT interval, at least 5 half-lives or 7 days (whichever is longer) prior to the first dose of DAN-222.
  • History of myelodysplasia, or has a known additional malignancy that progressed or required active treatment within the last 3 years. Exceptions include non-melanoma skin cancer and carcinoma in situ.
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  • Carcinomatous meningitis.
  • Subject is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
  • Inability to comply with study procedures or unwilling to use adequate birth control.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia that would limit compliance with study requirements.
  • Subject has a heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening.
  • Any serious social, psychosocial, or medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the subject's safe participation in and through a minimum of 4 cycles of treatment, or which could affect compliance with the protocol or interpretation of results.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Saint Luke's Cancer Institute

    Jackson, Missouri, 64111

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Sarah Cannon Research Institute/Tennessee Oncology

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15232

  • UCLA - Parkside Cancer Center

    Santa Monica, California, 90404

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib:

  • Part A is dose escalation of single agent DAN-222
  • Part B is dose escalation of DAN-222 in combination with niraparib
Being tested
DAN-222, Niraparib

What participants receive

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

  • DAN-222Drug

    Administered IV every week to subjects

  • NiraparibDrug

    Administered orally once daily

Study groups in NCT05261269
Study groupRoleWhat they receive
Dose Escalation (DAN-222)ExperimentalThe starting dose of DAN-222 will be administered IV every week (QW) to subjects in the first cohort.
Receives: Drug: DAN-222
Dose Escalation (DAN-222 + niraparib)ExperimentalThe starting dose of DAN-222 will be administered IV every week (QW), in combination with daily oral niraparib.
Receives: Drug: DAN-222; Drug: Niraparib

What is being measured

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

  1. Incidence and nature of Dose Limiting Toxicities (DLTs)

    Measured: 3 years

  2. Incidence, nature, and severity of adverse events graded according to NCI CTCAE v5.0

    Measured: 3 years

  3. Total exposure (area under the curve) from time 0 to the last measurable concentration (AUC0-last)

    Measured: 3 years

  4. Maximum observed plasma concentration (Cmax)

    Measured: 3 years

  5. Minimum observed plasma concentration (Cmin through concentration)

    Measured: 3 years

  6. Terminal half-life (t1/2)

    Measured: 3 years

  7. Clearance rate

    Measured: 3 years

  8. Volume of distribution

    Measured: 3 years

Secondary outcomes (5)

  1. Objective response per RECIST v1.1, defined as the proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by Investigator review.

    Measured: 3 years

  2. Progression-free survival per RECIST v1.1, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review.

    Measured: 3 years

  3. Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.

    Measured: 3 years

  4. Clinical benefit rate (CBR) per RECIST v1.1, defined as the proportion of patients having a BOR of SD ≥ 6 months, PR or CR as determined by Investigator review.

    Measured: 3 years

  5. Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by Investigator review with use of RECIST v1.1, or death from any cause during the study.

    Measured: 3 years

Timeline

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

  1. First posted2 Mar 2022
  2. Study start2 Feb 2022
  3. Primary completion13 Sep 2023
  4. Study completion11 Oct 2023

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261269
Sponsor's protocol ID
DAN-22220205
Status last verified
Dec 2023
First submitted
15 Feb 2022
Last updated
13 Dec 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DAN-222 and Niraparib in people with HER2-negative Metastatic Breast Cancer, run by Dantari, Inc. at 9 sites 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 19 inclusion and 12 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: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and nature of Dose Limiting Toxicities (DLTs) (time frame: 3 years). The study lists 8 primary outcomes in all. 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 NCT05261269.

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 13 Dec 2023.

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