Trial Outcomes & Findings for Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer (NCT NCT02293954)

Last Updated: 2025-11-14

Results Overview

Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day1 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

20 participants

Primary outcome timeframe

At day 1

Results posted on

2025-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 Participants Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Age, Continuous	57 years n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	14 Participants n=10 Participants
Race/Ethnicity, Customized Asian	4 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=10 Participants
Race/Ethnicity, Customized Non-Hispanic White	10 Participants n=10 Participants
Region of Enrollment United States	20 participants n=10 Participants
Tumor Stage @ Diagnosis I	1 Participants n=10 Participants
Tumor Stage @ Diagnosis II	1 Participants n=10 Participants
Tumor Stage @ Diagnosis III	5 Participants n=10 Participants
Tumor Stage @ Diagnosis IV	11 Participants n=10 Participants
Tumor Stage @ Diagnosis Unknown	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: At day 1

Outcome measures

Outcome measures
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 Participants Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1	22.0 SUVmax (g/mL) Standard Deviation 16.9

PRIMARY outcome

Timeframe: At day 2

Tumor uptake measured by SUVmax of 64Cu-DOTA-hT4.66-M5A at day 2 for hottest lesion from each patient. For tumors of at least 2 cm in diameter SUV (=tumor activity concentration/injected activity per unit body weight).

Outcome measures

Outcome measures
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 Participants Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2	30.7 SUVmax (g/mL) Standard Deviation 24.4

SECONDARY outcome

Timeframe: At 1 and 3 months post study drug infusion

Approximately 5 ml (1 teaspoon) of blood in a red top tube will be drawn at 1 month post study drug infusion and 3 months post study drug infusion. Response at either 1 or 3 months post study drug infusion constitutes a positive response.

Outcome measures

Outcome measures
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 Participants Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody	1 Participants

SECONDARY outcome

Timeframe: At day 1 and day 2

Scan results were compared to known sites of disease as defined by sites identified on CT scans, MRI scans, FDG PET scans, or sites identified at surgery that were histologically positive for cancer. The 64Cu SUVs on both day 1 and 2 scans were evaluated in tumors and selected nontumor organs and tissues (blood pool, liver, spleen, and kidney). Tumor uptake was measured in terms of SUVmax values, while organ uptake to assess biodistribution was measured in terms of SUVmean values. Ratios of tumor-to-blood activity concentration (T:B) were calculated as the ratio of tumor SUVmax to average SUV (SUVmean) measured in the blood pool.

Outcome measures

Outcome measures
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 Participants Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2 Day 1	3.3 T:B Standard Deviation 2.7
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2 Day 2	6.5 T:B Standard Deviation 4.9

Adverse Events

Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diagnostic (Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET) n=20 participants at risk Patients receive 15 mCi/5 mg copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2. radionuclide imaging: Given copper Cu 64 anti-CEA monoclonal antibody M5A IV positron emission tomography: Undergo PET Cu 64 anti-CEA monoclonal antibody M5A IV: Cu 64 anti-CEA monoclonal antibody M5A IV
Cardiac disorders Sinus bradycardia	15.0% 3/20 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Anemia	20.0% 4/20 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal pain	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastric perforation	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, spec	15.0% 3/20 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General disorders and administration sit	15.0% 3/20 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	15.0% 3/20 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	35.0% 7/20 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthralgia	15.0% 3/20 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	10.0% 2/20 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Libido decreased	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Genital edema	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Hirsutism	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pain of skin	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders -	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	75.0% 15/20 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place