Trial Outcomes & Findings for 111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen (NCT NCT00291447)

Last Updated: 2022-10-10

Results Overview

All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Documentation of AEs includes: date and time of onset and resolution, severity, frequency, seriousness, related interventions and outcome. Dose limiting toxicity (DLT) was defined as any Grade 2 or greater allergic reaction related to 111In-ch806 antibody protein, and any Grade 4 haematological or Grade 3 or greater non-haematological toxicity except for skin rash, occurring within 30 days of the 111In-ch806 infusion.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

30 days

Results posted on

2022-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Overall Study STARTED	2	2	2	2
Overall Study COMPLETED	2	2	2	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	4 Participants n=36 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	4 Participants n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment Australia	2 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants	2 participants n=483 Participants	8 participants n=36 Participants
Karnofsky performance status 80-100%	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants
Karnofsky performance status 50-70%	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All patients

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Number of Patients With Adverse Events Number of patients reporting at least 1 adverse event	2 Participants	2 Participants	2 Participants	2 Participants
Number of Patients With Adverse Events Dose limiting toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 post 111In-ch806 infusion.

Population: All patients

Gamma camera images were acquired on Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 post 111In-ch806 infusion. Image analysis was performed by defining regions of interest (ROIs) around the kidneys, liver, spleen and lungs and whole body. T1/2-biol was calculated from the whole body anterior and posterior planar images. A ROI was calculated to encompass the whole body via a morphological dilation and erosion of a binarized planar image, at a user-defined threshold taken as a percentage (0.9 - 1.5%) of maximum pixel value of the planar image. From each ROI at each time point, the mean counts per pixel per minute was normalised to imaging time point Day 0. From this time-activity curve (TAC), an exponential clearance expression was fitted to obtain effective halftime. This was then corrected for the physical half-life of 111In (67.45 hours) to account for physical decay to obtain the biological halftime.

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Biodistribution of 111In-ch806 Using Whole Body Clearance Methodology or Biological Halftime (T1/2-biol) Following the First Infusion.	1258 hours Standard Deviation 381	931 hours Standard Deviation 649	915 hours Standard Deviation 207	689 hours Standard Deviation 255

SECONDARY outcome

Timeframe: Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion.

Population: All patients

Gamma camera images were acquired on Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion. Dosimetry analysis was performed for kidney, liver, spleen and lung. Organ radioactivity was estimated from the geometric mean (GM) of anterior and posterior sample region of interest (ROI) counts. Three regions were defined for the organs, a whole organ ROI, a sample organ ROI, and a background ROI. Average counts within sample ROIs (counts/pixel) were multiplied by the area of the organ (pixels), determined from the whole organ ROI at the time point. For paired organs,a single organ area was measured and then multiplied by two to find total area. The counts for each organ were corrected for background. A time-activity curve (TAC) was generated and fitted with a single component exponential clearance expression. The number of disintegrations, or cumulated activity, was calculated for each organ.

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion. Kidney	0.370 mGy/MBq Standard Deviation 0.026	0.365 mGy/MBq Standard Deviation 0.068	0.359 mGy/MBq Standard Deviation 0.002	0.3428 mGy/MBq Standard Deviation 0.033
Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion. Liver	0.504 mGy/MBq Standard Deviation 0.016	0.652 mGy/MBq Standard Deviation 0.088	0.501 mGy/MBq Standard Deviation 0.053	0.475 mGy/MBq Standard Deviation 0.064
Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion. Lungs	0.152 mGy/MBq Standard Deviation 0.036	0.169 mGy/MBq Standard Deviation 0.061	0.163 mGy/MBq Standard Deviation 0.001	0.156 mGy/MBq Standard Deviation 0.014
Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion. Spleen	0.194 mGy/MBq Standard Deviation NA Patient 001 had splenectomy: therefore, only 1 subject included.	0.313 mGy/MBq Standard Deviation 0.035	0.450 mGy/MBq Standard Deviation 0.189	0.399 mGy/MBq Standard Deviation 0.035

SECONDARY outcome

Timeframe: Day 0 (1-4 hours after 111In-ch806 infusion), Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion.

Population: All patients

Whole body gamma camera imaging with anterior and posterior whole body scans using conjugate view methodology were performed for assessment of biodistribution and tumour uptake on Day 0 (1-4 hours after 111In-ch806 infusion), Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion. Target lesions (\>2cm) were used to measure uptake of 111In-ch806.

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Number of Patients With Tumour Uptake of 111In-ch806 Based on Qualitative Assessment of Biodistribution Images and Dosimetry Following the First Infusion.	2 Participants	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 0 - pre 111In-ch806 infusion; then at 5 minutes, 60 minutes, 2 hours and 4 hours post 111In-ch806 infusion, Day 1, Day 2 or 3, Day 4 or 5, Day 6 or 7, Day 14 (± 2 days) and Day 21 (± 2 days) and Day 30 (± 2 days) post infusion.

Population: All patients

The pharmacokinetics of 111In-ch806 were calculated based on gamma counting of serum samples. Serum samples for pharmacokinetics were collected on Day 0 - pre 111In-ch806 infusion; then at 5 minutes, 60 minutes, 2 hours and 4 hours post 111In-ch806 infusion, Day 1, Day 2 or 3, Day 4 or 5, Day 6 or 7, Day 14 (± 2 days) and Day 21 (± 2 days) and Day 30 (± 2 days) post infusion.

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Mean Half-life as Measured by Half-life of Initial Phase of Disposition (T½α) and Terminal Phase of Distribution (T½β) of 111In-ch806 Following the First Infusion . T½α (initial half life) of 111In-ch806	10.91 hours Standard Deviation 3.4	11.75 hours Standard Deviation 4.4	9.34 hours Standard Deviation 8.3	8.95 hours Standard Deviation 3.2
Mean Half-life as Measured by Half-life of Initial Phase of Disposition (T½α) and Terminal Phase of Distribution (T½β) of 111In-ch806 Following the First Infusion . T½β (terminal half life) of 111In-ch806	183.9 hours Standard Deviation 110.2	124.5 hours Standard Deviation 9.25	125.3 hours Standard Deviation 73.66	133.9 hours Standard Deviation 10.79

SECONDARY outcome

Population: All Patients

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Mean Volume of the Central Compartment (V1) of 111In-ch806 Following the First Infusion.	2963.06 mL Standard Deviation 493.23	3060.29 mL Standard Deviation 721.70	2902.06 mL Standard Deviation 1064.77	4742.42 mL Standard Deviation 169.10

SECONDARY outcome

Population: All patients

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Mean Total Serum Clearance (CL) of 111In-ch806 Following the First Infusion.	21.97 mL/hour Standard Deviation 16.59	28.58 mL/hour Standard Deviation 8.60	30.98 mL/hour Standard Deviation 21.65	37.99 mL/hour Standard Deviation 6.47

SECONDARY outcome

Population: All patients

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Mean Area Under the Serum Concentration Curve (AUC) of 111In-ch806 Following the First Infusion.	541.17 hour*mg/mL Standard Deviation 371.75	566.79 hour*mg/mL Standard Deviation 26.39	1438.12 hour*mg/mL Standard Deviation 957.18	2269.04 hour*mg/mL Standard Deviation 381.68

SECONDARY outcome

Timeframe: 30 days

Population: All patients

Tumor response was evaluated using computed tomography (CT) and categorized according to RECIST at screening (within 4 weeks of study start) and on day 30. Per RECIST, measurable lesions are categorized as follows: Complete Response (CR): complete disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); Progressive Disease (PD): ≥ 20% increase from nadir in TMTB; Stable Disease (SD): not meeting the above criteria.

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease	1 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: All patients

Patients each received a single infusion of 111In-ch806 on Day 0. To assess the secondary endpoint of immune response to ch806, patient serum samples were collected pre-infusion, then weekly until Day 30 (± 2 days) post infusion. Human antibody responses against the chimeric antibody (HACA) induced after treatment of patients were analyzed by an enzyme-linked immunosorbent assay (ELISA) technique. Patient sera was considered HACA positive if the normalized optical density (OD415) value exceeded a cut-off value of 37.10% (defined as the mean inter-patient baseline normalized OD value +3 SD of pretreatment sera).

Outcome measures

Outcome measures
Measure	Cohort 1 n=2 Participants Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 Participants Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 Participants Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 Participants Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Number of Patients With Human Anti-chimeric ch806 Antibodies (HACA) HACA positive	1 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Human Anti-chimeric ch806 Antibodies (HACA) HACA negative	1 Participants	2 Participants	2 Participants	2 Participants

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 4

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=2 participants at risk Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 2 n=2 participants at risk Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 3 n=2 participants at risk Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.	Cohort 4 n=2 participants at risk Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion. ch806: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Nervous system disorders increased intracranial pressure	50.0% 1/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) tumor hemorrhage	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	50.0% 1/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.
General disorders pain	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	50.0% 1/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.	0.00% 0/2 • 30 days All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Documentation of AEs includes: date and time of onset and resolution, severity using NCI CTCAE (Version 3.0), frequency, seriousness, related interventions and outcome.

Other adverse events

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place