Clinical trial · Interventional
NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)
A Phase I/II Study of NB1011 Administered Intravenously by Continuous Infusion in an Every Second Week Regimen With Open-label Continuation in Cancers That Overexpress the Enzyme Thymidylate Synthase
NCT00248404CI-TRIAL-00058511completedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NB1011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety/tolerability of NB1011 infusions
- measure
- Determination of maximum tolerated dose (MTD)
Secondary outcomes (3)
- measure
- Pharmacokinetics of NB1011 and its metabolite
- measure
- Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- measure
- Assessment of TS overexpression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced, recurrent, or metastatic solid tumors * TS overexpression (\> 4 by reverse transcription polymerase chain reaction \[RT-PCR\]) in archival and fresh samples * Suitable for experimental monotherapy * Measurable disease Exclusion Criteria: * Tumors that cannot be biopsied or with low level of TS expression * Requirement for concomitant anticancer therapy * Treatment with another investigational product within 30 days of study entry * Pregnant or lactating women * Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection. * HIV infection * Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis
References
Publications (4)
- BACKGROUNDNeuteboom ST, Karjian PL, Boyer CR, Beryt M, Pegram M, Wahl GM, Shepard HM. Inhibition of cell growth by NB1011 requires high thymidylate synthase levels and correlates with p53, p21, bax, and GADD45 induction. Mol Cancer Ther. 2002 Apr;1(6):377-84. PMID 12477050
- BACKGROUNDSalonga D, Danenberg KD, Johnson M, Metzger R, Groshen S, Tsao-Wei DD, Lenz HJ, Leichman CG, Leichman L, Diasio RB, Danenberg PV. Colorectal tumors responding to 5-fluorouracil have low gene expression levels of dihydropyrimidine dehydrogenase, thymidylate synthase, and thymidine phosphorylase. Clin Cancer Res. 2000 Apr;6(4):1322-7. PMID 10778957
- BACKGROUNDLenz HJ, Leichman CG, Danenberg KD, Danenberg PV, Groshen S, Cohen H, Laine L, Crookes P, Silberman H, Baranda J, Garcia Y, Li J, Leichman L. Thymidylate synthase mRNA level in adenocarcinoma of the stomach: a predictor for primary tumor response and overall survival. J Clin Oncol. 1996 Jan;14(1):176-82. doi: 10.1200/JCO.1996.14.1.176. PMID 8558194
- RESULTPegram M, Yeon CH, Ku N, Gottlieb C, Sheppard M, Cossum P, John E, Iqbal S, Garcia A, Lenz HJ. Enzyme Catalyzed Therapeutic Activation of NB1011 Selectively Targets Thymidylate Synthase-overexpressing Tumor Cells: Phase I Results. ASCO Meeting, New Orleans, June 4-8, 2004 (abstract 3144)