18 and older, any sex, with Lung Cancer. 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.
Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging.Primary· 28 days
Gamma camera imaging, including planar scans and single-photon emission computed tomography (SPECT) scans, were carried out immediately following completion of infusion and on two subsequent occasions during the next 6 days after the infusions of 111In-hu3S193 on weeks 1 and 4. A pretreatment FDG-positron emission tomography PET/CT scan was performed within 2 weeks of study entry per standard clinical methods for comparison with gamma camera imaging. FDG-PET/ CT scans and 111In planar and SPECT scans were evaluated for extent of disease and antibody targeting, respectively. Lesions on FDG-PET/
Group
Value
95% CI
hu3S193 10 mg/m2
5
hu3S193 20 mg/m2
5
Mean Half-life (T1/2) as Measured by 111In-hu3S193 RadioactivitySecondary· 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
T½α
Group
Value
95% CI
hu3S193 10 mg/m2
13.28
± 11.02
hu3S193 20 mg/m2
7.45
± 7.06
T½β
Group
Value
95% CI
hu3S193 10 mg/m2
126.22
± 35.35
hu3S193 20 mg/m2
129.60
± 51.93
Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 RadioactivitySecondary· 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
Group
Value
95% CI
hu3S193 10 mg/m2
3040.78
± 565.38
hu3S193 20 mg/m2
3468.07
± 686.79
Mean Clearance (CL) as Measured by 111In-hu3S193 RadioactivitySecondary· 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
Group
Value
95% CI
hu3S193 10 mg/m2
28.83
± 15.32
hu3S193 20 mg/m2
30.81
± 10.18
Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 RadioactivitySecondary· 4 weeks (days 1, 2, 3, and 5; weeks 1 and 4)
Blood samples for analysis of radioactivity and serum concentration of hu3S193 were obtained immediately before and 5, 60, and 120 minutes post-infusion, before and after imaging on day 2, and on days 3 and 5 after completion of the 111In-hu3S193 infusion in weeks 1 and 4. Pharmacokinetics was calculated using WinNonLin (Pharsight Co., Mountain View, CA). A two-compartment model was fitted to individually labeled infusions for each patient using unweighted nonlinear least squares to calculate pharmacokinetic parameters.
Group
Value
95% CI
hu3S193 10 mg/m2
859.97
± 347.19
hu3S193 20 mg/m2
1327.00
± 465.47
Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193.Secondary· 4 weeks (pre-dose, weeks 1, 2, 3, and 4)
Blood samples to measure human anti-human antibody (HAHA) assessments were obtained at baseline and each week before hu3S193 dosing. Measurement of immune responses to hu3S193 in patient blood samples was analyzed using a BIACORE (Piscataway, NJ) instrument using surface plasmon resonance (SPR).
Group
Value
95% CI
hu3S193 10 mg/m2
0
hu3S193 20 mg/m2
0
hu3S193 10 mg/m2
5
hu3S193 20 mg/m2
5
Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECISTSecondary· up to 28 days
Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Therasse P et al. 2000).
Group
Value
95% CI
hu3S193 10 mg/m2
0
hu3S193 20 mg/m2
0
hu3S193 10 mg/m2
0
hu3S193 20 mg/m2
0
hu3S193 10 mg/m2
0
hu3S193 20 mg/m2
0
hu3S193 10 mg/m2
5
hu3S193 20 mg/m2
5
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 8 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer (SCLC).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00006046 — Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
· Phase 1
· terminated
Other recruiting trials for Lung Cancer
Currently open trials in the same condition.
NCT07295821 — Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
· Phase 2
· recruiting
NCT06909201 — Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigatin
· Phase 1
· recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception
· recruiting
NCT07487064 — Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study
· NA
· recruiting
NCT07146568 — Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hos
· NA
· recruiting
Other Ludwig Institute for Cancer Research trials
Trials by the same sponsor.
NCT03164772 — Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC
· Phase 1, PHASE2
· completed
NCT02963831 — A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
· Phase 1, PHASE2
· completed
NCT02898116 — Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
· Phase 1, PHASE2
· completed
NCT02643303 — A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
· Phase 1, PHASE2
· completed
NCT02716805 — Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant
· Phase 1
· terminated
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: 4 October 2023
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/NCT00084799.