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PolyPEPI1018 CRC Vaccine

Phase 1

Colorectal Cancer | Vaccine | Oncology |Labcorp Holdings Inc.|Last Updated: May 26, 2022

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

PolyPEPI1018 CRC Vaccine · 1 trial · 1 indication

Phase 1 1
NCT03391232PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO)Colorectal Cancer
COMPLETED11 Analytics
PHASE1COMPLETED
PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO)
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Related Adverse Events
from 1st vaccination to 21 days after last vaccinations, up to 41 weeks

Occurrence of at least 1 ≥Grade 4 local adverse event (AE) or 1 ≥Grade 3 systemic AE and/or signs/symptoms, lab toxicities, and/or clinical events that is probably or definitely related to study treatment

Secondary Endpoints

Number of Participants Having T Cell Immune Response
12 weeks
Number of Predicted Antigen Specific T Cell Responses Per Patient
21 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PolyPEPI1018 CRC VaccineEXPERIMENTALThe vaccine contains 6 synthetic peptides mixed with the adjuvant Montanide™. The peptides were selected to induce T cell responses against 12 dominant epitopes from 7 cancer testis antigens (CTAs), which are the most frequently expressed CTAs in colorectal cancer. The 6 peptides were optimized to induce long lasting CRC specific T cell responses.

Interventions

NameTypeDescription
PolyPEPI1018 CRC VaccineBIOLOGICALColorectal Cancer Vaccine
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female subjects, 18-75 years of age at time of Screening who provide written informed consent prior to initiation of any study procedure 2. Histologically confirmed metastatic adenocarcinoma originating from the colon or the rectum 3. Presence of at least 1 measurable...

Countries:United StatesItaly
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Competitive Landscape -Colorectal Cancer 257 trials