NCT03000257 is a Phase 1 clinical trial of Venetoclax in Advanced Solid Tumors, sponsored by AbbVie.

Who is sponsoring NCT03000257?

NCT03000257 is sponsored by AbbVie.

What drugs are being tested in NCT03000257?

Interventions in NCT03000257: Venetoclax, Rovalpituzumab Tesirine, ABBV-181.

What condition does NCT03000257 study?

NCT03000257 studies Advanced Solid Tumors.

Is NCT03000257 still recruiting?

NCT03000257 is currently completed. Last updated 14 April 2022.

Last reviewed 2022-04-14 · How we verify

NCT03000257

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors

Completed Phase 1 Last updated 14 April 2022

What this trial tests

Phase 1 trial testing Venetoclax in Advanced Solid Tumors in 182 participants. Completed in 29 March 2022.

Timeline

14 December 2016

Primary endpoint
29 March 2022

29 March 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	182
Start date	14 December 2016
Primary completion	29 March 2022
Estimated completion	29 March 2022
Sites	26 locations across France, Finland, Japan, Belgium, Austria, Taiwan, Canada, Australia

Drugs / interventions tested

Venetoclax (venetoclax) — full drug profile →
Rovalpituzumab Tesirine — 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

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

Publications & conference data

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

Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
Gut OncoMicrobiome Signatures (GOMS) as next-generation biomarkers for cancer immunotherapy.
Thomas AM, Fidelle M, Routy B, Kroemer G, et al · · 2023 · cited 100× · PMID 37365438 · DOI 10.1038/s41571-023-00785-8
Inhibition of Anti-Apoptotic Bcl-2 Proteins in Preclinical and Clinical Studies: Current Overview in Cancer.
D'Aguanno S, Del Bufalo D. · · 2020 · cited 98× · PMID 32455818 · DOI 10.3390/cells9051287
BCL-2 family deregulation in colorectal cancer: potential for BH3 mimetics in therapy.
Ramesh P, Medema JP. · · 2020 · cited 91× · PMID 32335811 · DOI 10.1007/s10495-020-01601-9
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
Immune evasion in cancer: mechanisms and cutting-edge therapeutic approaches.
Tufail M, Jiang CH, Li N. · · 2025 · cited 82× · PMID 40739089 · DOI 10.1038/s41392-025-02280-1
Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy.
Boyero L, Sánchez-Gastaldo A, Alonso M, Noguera-Uclés JF, et al · · 2020 · cited 78× · PMID 33322522 · DOI 10.3390/cancers12123729
Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295

Verify or expand the search:

Other trials of Venetoclax

Trials testing the same drug.

NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07511062 — Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML · Phase 1 · not yet recruiting

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03000257 (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 April 2022

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/NCT03000257.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing