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NCT03311477
A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
Phase 1 trial testing ABBV-399 in Advanced Solid Tumors Cancer in 9 participants. Completed in 4 March 2019.
4 March 2019
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 6 November 2017 |
| Primary completion | 4 March 2019 |
| Estimated completion | 4 March 2019 |
| Sites | 2 locations across Japan |
Drugs / interventions tested
- ABBV-399 — full drug profile →
Conditions studied
- Advanced Solid Tumors Cancer — all drugs for Advanced Solid Tumors Cancer →
Sponsor
AbbVie — full company profile →
Who can join
20 and older, any sex, with Advanced Solid Tumors Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors.
Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, et al · · 2021 · cited 10× · PMID 33675179 · DOI 10.1002/cam4.3815 -
[Research Progress of Antibody-drug Conjugates in Advanced Non-small Cell Lung Cancer].
Wang N, Zhao L, Zhang D, Jia Y, et al · · 2022 · cited 2× · PMID 35340165 · DOI 10.3779/j.issn.1009-3419.2022.102.01 -
Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.
Chow R, Zhang D, Kannout S, Ma A, et al · · 2026 · PMID 42068413 · DOI 10.1007/s00520-026-10674-2
Verify or expand the search:
- PubMed search for NCT03311477
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ABBV-399
Trials testing the same drug.
- NCT03574753 — Lung-MAP S1400K: c-MET Positive · Phase 2 · completed
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03311477 (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 AbbVie
- Last refreshed: 14 March 2019
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/NCT03311477.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing