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Monoclonal Antibodies

FPA150 for Breast Cancer (FPA150-001 Trial)

Phase < 1
Waitlist Available
Research Sponsored by Five Prime Therapeutics, 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 through study completion, average 24 weeks
Awards & highlights

Summary

This trial is testing a new cancer drug, FPA150, to see if it is safe and effective when used alone or in combination with another cancer drug, pembrolizumab.

Eligible Conditions
  • Breast Cancer
  • Solid Tumors
  • Endometrial Cancer
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
For Phase 1a dose escalation, dose exploration and combination safety lead-in the number of participants with adverse events as assessed by the latest version of CTCAE
For Phase 1a dose escalation, to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of FPA150
For Phase 1b, number of participants with adverse events as assessed by the latest version of CTCAE at the maximum tolerated dose (MTD) and/or recommended dose (RD) of FPA150
Secondary study objectives
Area under serum concentration-time curve of FPA150 in day*µg/mL
Clearance of FPA150 in mL/day/kg
Incidence of treatment emergent anti-FPA150 antibody response (levels in serum)
+4 more
Other study objectives
For Phase 1b, to evaluate the overall response rate (ORR) defined as the total number of patients with complete response (CR) or partial response (PR) per RECIST v1.1 divided by the total number of patients who are evaluable for a response

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
SORE THROAT
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1a dose escalation/1b dose expansionExperimental Treatment2 Interventions
The study consists of Phase 1a dose escalation, Phase 1a dose exploration, Phase 1a combination safety-lead-in and Phase 1b dose expansion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FPA150
2018
Completed Early Phase 1
~100
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Five Prime Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
810 Total Patients Enrolled
~13 spots leftby Sep 2025
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