18 and older, any sex, with Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 InfusionsPrimary· Up to 43 days
Tumor localization was assessed using gamma camera imaging performed after the initial infusion of 111\^In-CS-1008 on Day 1 and then on Days 2, 4/5, 7/8, and 11/12 (collectively, "After Day 1 Infusion" in the table) and after the second infusion of 111\^In-CS-1008 on Day 36 and then on Days 37, 39/40, and 42/43 (collectively, "After Day 36 Infusion" in the table). Dosimetry calculations were performed to determine the tumor localization properties of 111\^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111\^In-CS-1008 were performed based on conjugate view images o
After Day 1 infusion: High, Specific Uptake
Group
Value
95% CI
Cohort 1
0
Cohort 2
3
Cohort 3
3
Cohort 4
3
Cohort 5
3
After Day 1 infusion: No Uptake
Group
Value
95% CI
Cohort 1
2
Cohort 2
1
Cohort 3
2
Cohort 4
0
Cohort 5
2
After Day 36 infusion: High, Specific Uptake
Group
Value
95% CI
Cohort 1
0
Cohort 2
3
Cohort 3
3
Cohort 4
3
Cohort 5
3
After Day 36 infusion: No Uptake
Group
Value
95% CI
Cohort 1
2
Cohort 2
1
Cohort 3
1
Cohort 4
0
Cohort 5
2
Mean Tumor Uptake of 111^In-CS-1008 Based on Gamma Camera Imaging Following the Day 1 and Day 36 InfusionsPrimary· Up to 43 days
Tumor localization was assessed using gamma camera imaging performed on Days 7/8 and 42/43. Dosimetry calculations were performed to determine the tumor localization properties of 111\^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111\^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses.
Post-infusion tumor uptake: Day 7/8
Group
Value
95% CI
Cohort 2
0.0042
± 0.0013
Cohort 3
0.0063
± 0.0004
Cohort 4
0.0044
± 0.0015
Cohort 5
0.0043
± 0.0006
Post-infusion tumor uptake: Day 42/43
Group
Value
95% CI
Cohort 2
0.0045
± 0.0005
Cohort 3
0.0061
± 0.0011
Cohort 4
0.0044
± 0.0012
Cohort 5
0.0036
± 0.0007
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008Primary· Up to 36 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Initial half-life
Group
Value
95% CI
Cohort 1
14.51
± 5.95
Cohort 2
21.52
± 5.76
Cohort 3
5.29
± 4.76
Cohort 4
10.45
± 6.85
Cohort 5
14.73
± 4.72
Terminal half-life
Group
Value
95% CI
Cohort 1
284.76
± 0.38
Cohort 2
264.89
± 122.12
Cohort 3
163.08
± 39.86
Cohort 4
243.39
± 52.21
Cohort 5
247.5
± 52.9
Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008Primary· Up to 36 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Group
Value
95% CI
Cohort 1
3209.83
± 321.96
Cohort 2
2592.36
± 303.21
Cohort 3
3329.11
± 624.49
Cohort 4
2658.70
± 112.60
Cohort 5
4037
± 425
Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008Primary· Up to 36 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Group
Value
95% CI
Cohort 1
986.58
± 125.11
Cohort 2
5706.38
± 2632.72
Cohort 3
8386.68
± 855.70
Cohort 4
18714.05
± 1511.25
Cohort 5
28492
± 1598
Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008Primary· Up to 36 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Group
Value
95% CI
Cohort 1
14.92
± 2.5
Cohort 2
12.31
± 3.38
Cohort 3
18.23
± 0.51
Cohort 4
12
± 2.03
Cohort 5
18.52
± 2.61
Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008Primary· Up to 36 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Group
Value
95% CI
Cohort 1
4.59
± 0.89
Cohort 2
24.6
± 3.75
Cohort 3
47.29
± 10.19
Cohort 4
84.14
± 11
Cohort 5
131.3
± 20.1
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008Primary· Up to 50 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Initial half-life
Group
Value
95% CI
Cohort 2
12.21
± 6.13
Cohort 3
15.84
± 13.25
Cohort 4
15.01
± 3.48
Cohort 5
15.56
± 4.17
Terminal half-life
Group
Value
95% CI
Cohort 2
186.2
± 36.3
Cohort 3
247.5
± 109.3
Cohort 4
347
± 202
Cohort 5
260.5
± 51.1
Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008Primary· Up to 50 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Group
Value
95% CI
Cohort 2
2510
± 313
Cohort 3
3272
± 733
Cohort 4
2742
± 304
Cohort 5
3985
± 660
Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008Primary· Up to 50 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Group
Value
95% CI
Cohort 2
9013
± 1629
Cohort 3
9772
± 626
Cohort 4
10990
± 3205
Cohort 5
10465
± 3286
Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008Primary· Up to 50 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Group
Value
95% CI
Cohort 2
14.11
± 1.35
Cohort 3
15.29
± 2
Cohort 4
10.73
± 4.43
Cohort 5
19.00
± 6.48
Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008Primary· Up to 50 days
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Group
Value
95% CI
Cohort 2
51.08
± 11.62
Cohort 3
47.10
± 12.07
Cohort 4
40.98
± 9.77
Cohort 5
47.38
± 9.99
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a Phase 1, open-label, single-center study of CS-1008, an immunoglobulin G subclass 1 (IgG1) humanized monoclonal antibody, in subjects with advanced colorectal carcinoma who had received ≥ 1 prior chemotherapy regimen for metastatic disease. Primary study objectives were to determine the influence of the CS-1008 dose on the biodistribution, pharmacokinetics (PK) and tumor uptake of radiolabeled CS-1008 following a single infusion and following continuous sequential doses of CS-1008. Secondary objectives were to evaluate changes in tumor metabolism, antitumor response, and changes in serum apoptosis biomarkers and tumor response markers following treatment with CS-1008.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig Institute for Cancer Research
Last refreshed: 28 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01220999.