Clinical trial · Interventional
BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
NCT00346385CI-TRIAL-00017276completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BB-10901 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments
- timeFrame
- these tests will be conducted at various timepoints during a patients participation in the trial
Secondary outcomes (2)
- measure
- Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level
- timeFrame
- PK is assessed during the first cycle (21 days) of a patients participation
- measure
- Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)
- timeFrame
- efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS During Dose Escalation: * Histologically or cytologically confirmed diagnosis of 1 of the following: * Small cell lung cancer (SCLC) * Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features * Non-pulmonary small cell carcinoma * Metastatic carcinoid tumor * Other CD56-positive solid tumor * Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry * Relapsed or refractory disease * Must have received at least 1 but no more than 3 prior chemotherapy regimens\* and recovered from any acute toxicities * No prior chemotherapy for carcinoid or neuroendocrine tumors DISEASE CHARACTERISTICS During MTD Expansion: * Relapsed or refractory Small cell lung cancer (SCLC) * Metastatic Merkel Cell carcinomas * Ovarian carcinomas At the MTD: SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen. * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure) * No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids. PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Bilirubin ≤ 3 times ULN * No rapidly rising liver function tests (LFTs) * Pancreatic function, amylase and lipase within upper limit of normal. * No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy * No myocardial infarction within the past 6 months * No unstable angina pectoris * No uncontrolled congestive heart failure * No uncontrolled arrhythmia * No severe aortic stenosis * No history of multiple sclerosis or other demyelinating disease * No Eaton-Lambert syndrome (para-neoplastic syndrome) * No history of hemorrhagic stroke * No CNS injury with residual neurologic deficit * No ischemic stroke within the past 6 months * No history of pancreatitis * No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus * No other concurrent serious infection * No chronic alcoholism * No other concurrent illness or condition that would interfere with study outcome * No other malignancy within the past 3 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Total cumulative dosage of prior anthracycline treatment must not exceed threshold for cardiotoxicity * No known hypersensitivity to previous monoclonal antibody therapy * More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy * More than 4 weeks since prior and no other concurrent investigational agents * At least 4 weeks since prior and no concurrent surgery * No other concurrent antineoplastic treatment, including immunotherapy or steroid therapy
References
Publications (0)
Data not yet available
No reference posted for this study.