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NCT01946074
A Study of ABT-165 in Subjects With Solid Tumors
Phase 1 trial testing paclitaxel in Advanced Solid Tumors in 101 participants. Completed in 28 September 2022.
28 September 2022
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 8 August 2013 |
| Primary completion | 28 September 2022 |
| Estimated completion | 28 September 2022 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- paclitaxel — full drug profile →
- FOLFIRI (folfiri) — full drug profile →
- ABT-165 — full drug profile →
- ABBV-181 — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
AbbVie — full company profile →
Who can join
Adults 18 to 99, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging new therapeutic antibody derivatives for cancer treatment.
Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x -
Targeting the Notch Signaling Pathway in Chronic Inflammatory Diseases.
Christopoulos PF, Gjølberg TT, Krüger S, Haraldsen G, et al · · 2021 · cited 86× · PMID 33912195 · DOI 10.3389/fimmu.2021.668207 -
Expanding the Boundaries of Biotherapeutics with Bispecific Antibodies.
Husain B, Ellerman D. · · 2018 · cited 83× · PMID 30132211 · DOI 10.1007/s40259-018-0299-9 -
Biology drives the discovery of bispecific antibodies as innovative therapeutics.
Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003 -
Principles and Current Clinical Landscape of Multispecific Antibodies against Cancer.
Elshiaty M, Schindler H, Christopoulos P. · · 2021 · cited 71× · PMID 34073188 · DOI 10.3390/ijms22115632 -
Therapeutic Targeting of Notch Signaling: From Cancer to Inflammatory Disorders.
Allen F, Maillard I. · · 2021 · cited 62× · PMID 34124039 · DOI 10.3389/fcell.2021.649205 -
Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies.
You G, Won J, Lee Y, Moon D, et al · · 2021 · cited 39× · PMID 34358141 · DOI 10.3390/vaccines9070724 -
Targeting Notch to Maximize Chemotherapeutic Benefits: Rationale, Advanced Strategies, and Future Perspectives.
Zhdanovskaya N, Firrincieli M, Lazzari S, Lazzari S, et al · · 2021 · cited 28× · PMID 34680255 · DOI 10.3390/cancers13205106
Verify or expand the search:
- PubMed search for NCT01946074
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
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Trials by the same sponsor.
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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 NCT01946074 (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: 15 December 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/NCT01946074.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing