Table 2 Adverse events and summary for study participants

From: Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial

 

Cohort 1 (0.1 mg) n = 3

Cohort 2 (0.5 mg) n = 6

Cohort 3 (2.5 mg) n = 5

Cohort 4 (5.0 mg) n = 5

Cohort 5 (10.0 mg) n = 6

Overall n = 25

Adverse event terma

Patients with any related TEAE, n (%)

1 (33.3)

3 (50.0)

2 (40.0)

2 (40.0)

4 (66.7)

12 (48.0)

Fatigue

0

2 (33.3)

2 (40.0)

1 (20.0)

1 (16.7)

6 (24.0)

Injection site reaction*

1 (33.3)

1 (16.7)

0

2 (40.0)

0

4 (16.0)

Myalgia

0

0

0

1 (20.0)

2 (33.3)

3 (12.0)

Anemia

1 (33.3)

0

1 (20.0)

0

0

2 (8.0)

Headache

1 (33.3)

1 (16.7)

0

0

0

2 (8.0)

Hot flush

0

1 (16.7)

0

0

1 (16.7)

2 (8.0)

Nasal congestion

0

1 (16.7)

0

1 (20.0)

0

2 (8.0)

Nausea

1 (33.3)

0

0

1 (20.0)

0

2 (8.0)

Patient summaryb

KRAS mutation

DDD

DDDDDD

DRDDD

DDRDD

RRDDRD

 

DLT

0

0

0

0

0

0

Biomarker reduction/clearance

2 (67)

5 (83)

4 (80)

4 (80)

6 (100)

21 (84)

T cell response

2 (67)

4 (67)

4 (80)

5 (100)

6 (100)

21 (84)

  1. aTEAE, treatment-emergent adverse events with incidence ≥5%; data cutoff, 6 September 2023; preferred terms per the Medical Dictionary for Regulatory Activities, version 25.0
  2. * Injection site reaction includes injection site erythema, injection site induration, injection site swelling, contusion and pruritis.
  3. b Patient summary.
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