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Monoclonal Antibodies

Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer (PRIMUS Trial)

Florence, AL
Phase 3
Waitlist Available
Research Sponsored by HiberCell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.

See full description
Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Insomnia
18%
Aspartate aminotransferase increased
18%
Headache
18%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Peripheral sensory neuropathy
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Dizziness
10%
Arthralgia
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Pleural effusion
5%
Allergic rhinitis
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Peripheral motor neuropathy
3%
Tracheostomy site bleeding
3%
Vertigo
3%
Laryngeal obstruction
3%
Pharyngeal hemorrhage
3%
Alopecia
3%
Oral pain
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Imprime PGG + cetuximabExperimental Treatment1 Intervention
Biological/Vaccine + Drug
Group II: Arm 2: cetuximabActive Control1 Intervention
Drug

Find a Location

Closest Location:Northwest Alabama Cancer Center· Florence, AL

Who is running the clinical trial?

HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
647 Total Patients Enrolled
~15 spots leftby Mar 2026
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