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NCT01363947

Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer

Completed Phase 1 Last updated 7 June 2017
What this trial tests

Phase 1 trial testing DNIB0600A in Non-Small Cell Lung Cancer, Ovarian Cancer in 87 participants. Completed in 3 June 2016.

Timeline
14 June 2011
Primary endpoint
3 June 2016
3 June 2016

Quick facts

Lead sponsorGenentech, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment87
Start date14 June 2011
Primary completion3 June 2016
Estimated completion3 June 2016
Sites7 locations across United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Genentech, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer, Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Drug resistance in ovarian cancer: from mechanism to clinical trial.
    Wang L, Wang X, Zhu X, Zhong L, et al · · 2024 · cited 139× · PMID 38539161 · DOI 10.1186/s12943-024-01967-3
  2. Exploration of the antibody-drug conjugate clinical landscape.
    Maecker H, Jonnalagadda V, Bhakta S, Jammalamadaka V, et al · · 2023 · cited 90× · PMID 37639687 · DOI 10.1080/19420862.2023.2229101
  3. Antibody-drug conjugates in lung cancer: dawn of a new era?
    Coleman N, Yap TA, Heymach JV, Meric-Bernstam F, et al · · 2023 · cited 89× · PMID 36631624 · DOI 10.1038/s41698-022-00338-9
  4. Clinical pharmacology of vc-MMAE antibody-drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies.
    Li C, Zhang C, Li Z, Samineni D, et al · · 2020 · cited 44× · PMID 31852341 · DOI 10.1080/19420862.2019.1699768
  5. Current Status of Marine-Derived Compounds as Warheads in Anti-Tumor Drug Candidates.
    Newman DJ, Cragg GM. · · 2017 · cited 43× · PMID 28353637 · DOI 10.3390/md15040099
  6. The clinical development of antibody-drug conjugates for non-small cell lung cancer therapy.
    Liu X, Deng J, Zhang R, Xing J, et al · · 2023 · cited 15× · PMID 38162667 · DOI 10.3389/fimmu.2023.1335252
  7. 9th annual European Antibody Congress, November 11-13, 2013, Geneva, Switzerland.
    Reichert JM, Beck A, Lugovskoy AA, Wurch T, et al · · 2014 · cited 12× · PMID 24492298 · DOI 10.4161/mabs.27903
  8. A review of recent advances on single use of antibody-drug conjugates or combination with tumor immunology therapy for gynecologic cancer.
    Wang AJ, Gao Y, Shi YY, Dai MY, et al · · 2022 · cited 10× · PMID 36618922 · DOI 10.3389/fphar.2022.1093666

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Data sources for this page

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/NCT01363947.

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