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PCA062

Phase 1

Triple Negative Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

PCA062 · 1 trial · 3 indications

Phase 1 1
NCT02375958PCA062 in pCAD-positive Tumors.Triple Negative Breast Cancer
COMPLETED47 Analytics
PHASE1COMPLETED
PCA062 in pCAD-positive Tumors.
Triple Negative Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence rate of dose limiting toxicities
28 days

Secondary Endpoints

Incidence and severity of serious/adverse events
Duration of study (each treatment cycle = 14 days)
Pharmacokinetic parameter Cmax
84 days
Presence of PCA062 anti-bodies
84 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Triple Negative Breast CancerEXPERIMENTAL -
Head and Neck CancerEXPERIMENTAL -
Esophageal CancerEXPERIMENTAL -

Interventions

NameTypeDescription
PCA062DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: 1. Male or female ≥ 18 years of age 2. 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. 3. ...

Countries:United StatesFranceItalyJapanSingaporeSpain
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Frequently asked questions about PCA062

What is PCA062 used for?

PCA062 is an investigational small molecule being studied for the treatment of triple negative breast cancer. It is also being evaluated in head and neck cancer and esophageal cancer. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does PCA062 target?

PCA062 targets pCAD, a protein that is present in certain tumors. The drug is designed to bind to pCAD-positive cells, which are found in triple negative breast cancer, head and neck cancer, and esophageal cancer. This targeted approach is being investigated in a Phase 1 clinical trial.

Who makes PCA062?

PCA062 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of PCA062 in cancer patients.

What phase is PCA062 in?

PCA062 is currently in Phase 1 clinical development. It has completed one Phase 1 trial, which was a controlled study involving 47 participants. The drug is still investigational and has not received FDA approval for any indication.

What clinical trials is PCA062 in?

PCA062 has been studied in one clinical trial with the identifier NCT02375958, titled 'PCA062 in pCAD-positive Tumors.' This Phase 1 study enrolled 47 participants with triple negative breast cancer, head and neck cancer, or esophageal cancer. The trial was conducted in the United States, France, Italy, Japan, Singapore, and Spain.

Is PCA062 the same as any other drug?

PCA062 is a unique investigational compound developed by Novartis. It is not known to be marketed under any other name. The drug is being studied specifically for its ability to target pCAD-positive tumors, and it remains in early-stage clinical development.