Triple Negative Breast CancerPhase 1NCT02375958
PCA062 in pCAD-positive Tumors.
A Phase 1 study testing PCA062 in people with Triple Negative Breast Cancer and Head & Neck Cancer, run by Novartis Pharmaceuticals at 7 sites in 6 countries.
Trial summary
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer
- What is being tested?
- PCA062
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 15 Apr 2015to 17 Jul 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
- Consent for a tumor biopsy at screening
- Progressive disease and no effective therapy exists
- Measurable disease as per RECIST v1.1 criteria
- ECOG Performance status of ≤ 2
Who cannot join
- CNS metastatic involvement
- Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
- A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
- Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
- Previously treated with anti-pCAD biologic therapies.
- Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
Show all 21Show fewer
- Conventional cytotoxic chemotherapy: ≤4 weeks
- Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
- Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
- Other investigational agents: ≤4 weeks
- Radiation therapy (palliative setting is allowed.): ≤4 weeks
- Major surgery: ≤2 weeks
- Patient has out of range laboratory values defined as:
- Hematological values:
- Absolute neutrophil count (ANC) <1.5 x 109/L
- Hemoglobin (Hgb) <9 g/dL
- Platelets <100 x 109/L
- Hepatic and renal function
- Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN for patients without tumor involvement of the liver or >5 x ULN for patients with tumor involvement of the liver.
- Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United States2 sites
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
- Being tested
- PCA062
- Keywords
- PCA062, Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer, pCAD, pcadherin, solid-tumors
- Medical subject headings
- Triple Negative Breast Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCA062Drug
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer | Experimental | Not described Receives: Drug: PCA062 |
| Head and Neck Cancer | Experimental | Not described Receives: Drug: PCA062 |
| Esophageal Cancer | Experimental | Not described Receives: Drug: PCA062 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose limiting toxicities
Measured: 28 days
Secondary outcomes (9)
Incidence and severity of serious/adverse events
Measured: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic parameter Cmax
Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug
Measured: 84 days
Presence of PCA062 anti-bodies
The presence and/or concentration of the anti-bodies will be tested from the blood samples collected
Measured: 84 days
Overall response rate
Measured: Duration of study (each treatment cycle = 14 days)
Duration of response
Measured: Duration of study (each treatment cycle = 14 days)
Progression free survival
Measured: 18 months
Disease control rate
Measured: 18 months
Best overall response
Measured: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic paramater Tmax
Tmax = the time the drug takes to reach maximum (peak) concentration in the blood
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start15 Apr 2015
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375958
- Sponsor's protocol ID
- CPCA062X2101
- Other IDs
- 2014-003732-40, 2014
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2015
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652.
PubMed 35131875
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors
- ClinicalTrials.gov ID
- NCT02375958
- Acronym / sponsor ID
- CPCA062X2101
- Keywords
- PCA062, Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer, pCAD, pcadherin, solid-tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer | Experimental | Drug: PCA062 |
| Head and Neck Cancer | Experimental | Drug: PCA062 |
| Esophageal Cancer | Experimental | Drug: PCA062 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age
- Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
- Consent for a tumor biopsy at screening
- Progressive disease and no effective therapy exists
- Measurable disease as per RECIST v1.1 criteria
Key exclusion criteria (21 listed)
- CNS metastatic involvement
- Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
- A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
- Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
- Previously treated with anti-pCAD biologic therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCA062 | Drug | Esophageal Cancer, Head and Neck Cancer, Triple Negative Breast Cancer |
Primary outcome
Incidence rate of dose limiting toxicities
Time frame: 28 days
9 secondary outcomes
Incidence and severity of serious/adverse events
Time frame: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic parameter Cmax
Time frame: 84 days
Presence of PCA062 anti-bodies
Time frame: 84 days
Overall response rate
Time frame: Duration of study (each treatment cycle = 14 days)
Duration of response
Time frame: Duration of study (each treatment cycle = 14 days)
Progression free survival
Time frame: 18 months
Disease control rate
Time frame: 18 months
Best overall response
Time frame: Duration of study (each treatment cycle = 14 days)
Pharmacokinetic paramater Tmax
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 35131875Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652.
- Results for CPCA062X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PCA062 in people with Triple Negative Breast Cancer and Head & Neck Cancer, run by Novartis Pharmaceuticals at 7 sites in 6 countries.
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 6 inclusion and 21 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Italy, Japan, Singapore and 1 more country. 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 rate of dose limiting toxicities (time frame: 28 days). 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 NCT02375958, which also lists 1 linked publication.
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 19 Dec 2020.