Evidence map›Paper›PMID 24691674›Full record

Trial reportInvestigational new drugs2014

Phase 1/2 study of KRN330, a fully human anti-A33 monoclonal antibody, plus irinotecan as second-line treatment for patients with metastatic colorectal cancer.

Johanna C Bendell, Heinz-Josef Lenz, Theresa Ryan, Bassel F El-Rayes, John L Marshall, Manuel R Modiano, Lowell L Hart, Clint D Kingsley, Thomas J George, Daisuke Nakashima and 1 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Johanna C BendellSarah Cannon Research Institute/Tennessee Oncology, PLLC, Suite 110, 250 25th Avenue North, Nashville, TN, 37203, USA, jbendell@tnonc.com.
Heinz-Josef Lenz
Theresa Ryan
Bassel F El-Rayes
John L Marshall
Manuel R Modiano
Lowell L Hart
Clint D Kingsley
Thomas J George
Daisuke Nakashima
Jordan D Berlin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

KRN330 is a recombinant, fully-human monoclonal antibody directed against A33, a surface differentiation antigen that is uniformly expressed in 95 % of colorectal cancers. A previous Phase 1 study of single-agent KRN330 identified a maximum tolerated dose (MTD) of 3 mg/kg q2w and preliminary evidence of clinical activity among patients with advanced and metastatic colorectal cancer (mCRC). This Phase 1/2 trial sought to assess the safety and activity of second-line KRN330 plus irinotecan in patients with mCRC. Patients with mCRC who showed disease progression after FOLFOX/CapOx received intravenous doses of KRN330 (0.5 or 1.0 mg/kg qw or q2w) plus irinotecan (180 mg/m(2)) in a standard 3 + 3 dose escalation. The MTD of KRN330 with irinotecan in 19 patients was 0.5 mg/kg qw in the Phase 1 study with gastrointestinal effects and neutropenia being the predominant dose-limiting toxicities. In the Phase 2 study, the most frequent treatment-related Grade ≥3 toxicities in 44 patients were fatigue (15.9 %), neutropenia (13.6 %), leukopenia (6.8 %), diarrhea (4.5 %), and dehydration (4.5 %). Objective response rate (ORR) was 4.5 % and disease control rate was 45.5 % for the intent-to-treat population. Median progression-free survival was 87 days (95 % CI, 43-136 days). The prespecified ORR of KRN330 plus irinotecan was not met. Further investigation of KRN330 plus other agents may be warranted.

Indexed as

AdolescentAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, PhytogenicCamptothecinColorectal NeoplasmsDisease-Free SurvivalDisease ProgressionFemaleHumansIrinotecanMaleMaximum Tolerated DoseMembrane GlycoproteinsMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, PhytogenicCamptothecinGPA33 protein, humanIrinotecanKRN-330Membrane Glycoproteins

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.