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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00248404

Enrollment

155

Registered

2005-11-04

Start date

2005-09-30

Completion date

2007-12-12

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Keywords

colorectal cancer, ovarian cancer, lung cancer, breast cancer, small bowel cancer, Advanced, recurrent, or metastatic solid tumors of any type, TS overexpression confirmed by fresh biopsy (RTPCR), Suitable for experimental monotherapy

Brief summary

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.

Interventions

DRUGNB1011

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety/tolerability of NB1011 infusions	—
Determination of maximum tolerated dose (MTD)	—

Secondary

Measure	Time frame
Pharmacokinetics of NB1011 and its metabolite	—
Clinical activity as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria	—
Assessment of TS overexpression	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026