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NCT02254018
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
Completed
Phase 1
Last updated 24 October 2023
What this trial tests
Phase 1 trial testing bivatuzumab mertansine in Head and Neck Neoplasms in 31 participants. Completed.
Timeline
1 September 2002
Primary endpoint
1 February 2005
1 February 2005
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 1 September 2002 |
| Primary completion | 1 February 2005 |
Drugs / interventions tested
- bivatuzumab mertansine — full drug profile →
Conditions studied
- Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
18 and older, any sex, with Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances of antibody drug conjugates for clinical applications.
Zhao P, Zhang Y, Li W, Jeanty C, et al · · 2020 · cited 122× · PMID 33088681 · DOI 10.1016/j.apsb.2020.04.012 -
Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w -
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 -
Cancer Stem Cells in Head and Neck Squamous Cell Carcinoma: Identification, Characterization and Clinical Implications.
Peitzsch C, Nathansen J, Schniewind SI, Schwarz F, et al · · 2019 · cited 61× · PMID 31052565 · DOI 10.3390/cancers11050616 -
Targeting the Extra-Cellular Matrix-Tumor Cell Crosstalk for Anti-Cancer Therapy: Emerging Alternatives to Integrin Inhibitors.
Lorusso G, Rüegg C, Kuonen F. · · 2020 · cited 22× · PMID 32793493 · DOI 10.3389/fonc.2020.01231 -
Informed by Cancer Stem Cells of Solid Tumors: Advances in Treatments Targeting Tumor-Promoting Factors and Pathways.
MacLean MR, Walker OL, Arun RP, Fernando W, et al · · 2024 · cited 21× · PMID 38612911 · DOI 10.3390/ijms25074102 -
Targeting Cellular Components of the Tumor Microenvironment in Solid Malignancies.
Belli C, Antonarelli G, Repetto M, Boscolo Bielo L, et al · · 2022 · cited 18× · PMID 36077813 · DOI 10.3390/cancers14174278 -
The Role of CD44 in the Pathophysiology of Chronic Lymphocytic Leukemia.
Gutjahr JC, Greil R, Hartmann TN. · · 2015 · cited 14× · PMID 25941526 · DOI 10.3389/fimmu.2015.00177
Verify or expand the search:
- PubMed search for NCT02254018
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of bivatuzumab mertansine
Trials testing the same drug.
- NCT02254031 — Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer · Phase 1 · terminated
- NCT02254005 — Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer · Phase 1 · completed
Other recruiting trials for Head and Neck Neoplasms
Currently open trials in the same condition.
- NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
- NCT06912087 — Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC · Phase 1 · recruiting
- NCT06998069 — Head and Neck Cancer Study Project in the Geriatric Population · Phase 3 · recruiting
- NCT07158164 — DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment · Phase 4 · recruiting
- NCT06303180 — NIDCD Otolaryngology Clinical Protocol Biospecimen Bank · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02254018 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 24 October 2023
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/NCT02254018.
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