18 and older, any sex, with Renal Cell Carcinoma or Kidney Neoplasm. 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 Patients With Treatment-emergent Adverse EventsPrimary· Continuously for up to 5 months
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as follows for the purposes of dose escalation: Grade 4 hematopoietic toxicity in excess of 5 days or Grade 3 or greater nonhematopoietic toxicity.
Any TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Maximum grade 1 TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
2
Cohort 2 (0.3 mCi/kg)
2
Cohort 3 (0.4 mCi/kg)
2
Cohort 4 (0.45 mCi/kg)
1
Cohort 5 (0.55 mCi/kg)
0
Maximum grade 2 TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
0
Cohort 2 (0.3 mCi/kg)
1
Cohort 3 (0.4 mCi/kg)
1
Cohort 4 (0.45 mCi/kg)
0
Cohort 5 (0.55 mCi/kg)
0
Maximum grade 3 TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
1
Cohort 2 (0.3 mCi/kg)
0
Cohort 3 (0.4 mCi/kg)
3
Cohort 4 (0.45 mCi/kg)
1
Cohort 5 (0.55 mCi/kg)
1
Maximum grade 4 TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
0
Cohort 2 (0.3 mCi/kg)
0
Cohort 3 (0.4 mCi/kg)
0
Cohort 4 (0.45 mCi/kg)
1
Cohort 5 (0.55 mCi/kg)
2
Treatment-related TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
2
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
5
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Serious TEAE
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
0
Cohort 2 (0.3 mCi/kg)
0
Cohort 3 (0.4 mCi/kg)
1
Cohort 4 (0.45 mCi/kg)
1
Cohort 5 (0.55 mCi/kg)
0
TEAE Leading to Treatment Discontinuation
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
0
Cohort 2 (0.3 mCi/kg)
0
Cohort 3 (0.4 mCi/kg)
0
Cohort 4 (0.45 mCi/kg)
0
Cohort 5 (0.55 mCi/kg)
0
Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 AdministrationSecondary· Up to 5 months
In order to receive the therapeutic \^90Y-DOTA-cG250 injection on Day 8, 9, or 10, patients must have demonstrated tumor targeting to lesions \> 2 cm detected by CT scan and must not have exhibited the following characteristics following the nontherapeutic injection of \^111In-DOTA-cG250: excessive liver and/or spleen uptake; excessive uptake in the normal kidney; non-visualization of the cardiac blood pool in the first imaging set; whole body clearance half-life (t1/2) \< 1.5 days; serum t1/2 \< 2 days; rapid clearance of the radiopharmaceutical from the blood pool with prominent marrow uptak
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Number of Patients With Samples Collected for Evaluation of Human Antichimeric AntibodySecondary· Up to 6 months
Blood samples were drawn for evaluation of the human antichimeric antibody (HACA) at screening, between Days 22 and 28, between Days 36 and 42, between Days 43 and 57 or at the end of study, and during long-term follow-up (approximately 12 weeks later). Serial dilutions were tested by the enzyme-linked immunosorbent assay (ELISA) using the "double antibody sandwich" technique and pretreatment serum as negative control.
Baseline
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Day 28
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Day 42
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
3
Cohort 5 (0.55 mCi/kg)
3
Day 63
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
3
Cohort 2 (0.3 mCi/kg)
3
Cohort 3 (0.4 mCi/kg)
6
Cohort 4 (0.45 mCi/kg)
2
Cohort 5 (0.55 mCi/kg)
2
Long-term Follow-up
Group
Value
95% CI
Cohort 1 (0.2 mCi/kg)
0
Cohort 2 (0.3 mCi/kg)
0
Cohort 3 (0.4 mCi/kg)
0
Cohort 4 (0.45 mCi/kg)
0
Cohort 5 (0.55 mCi/kg)
1
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 occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 5 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, dose-escalation study of yttrium-90 conjugated chimeric G250 (\^90Y-DOTA-cG250) in patients with advanced, measurable clear cell renal cell carcinoma (RCC). Study objectives were to determine the safety, targeting, and dosimetry of \^90Y-DOTA-cG250, using indium-111 conjugated chimeric G250 (\^111In-DOTA-cG250) as a surrogate, as well as to evaluate the immunogenicity of cG250.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07195682 — A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
· Phase 1
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT07227402 — A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6
· Phase 3
· recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
· Phase 2
· recruiting
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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: 10 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/NCT00199875.