NCT04492033 is a Phase 1, PHASE2 clinical trial of CTX-009 (ABL001) in P1b: Advanced Solid Tumors, sponsored by Handok Inc..

Who is sponsoring NCT04492033?

NCT04492033 is sponsored by Handok Inc..

What drugs are being tested in NCT04492033?

Interventions in NCT04492033: CTX-009 (ABL001), Paclitaxel, Irinotecan.

What condition does NCT04492033 study?

NCT04492033 studies P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer.

Is NCT04492033 still recruiting?

NCT04492033 is currently terminated. Last updated 27 January 2025.

Last reviewed 2025-01-27 · How we verify

NCT04492033

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

A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

Terminated Phase 1, PHASE2 Last updated 27 January 2025

What this trial tests

Phase 1, PHASE2 trial testing CTX-009 (ABL001) in P1b: Advanced Solid Tumors in 41 participants. Terminated before completion.

Timeline

22 June 2020

Primary endpoint
8 January 2024

9 January 2025

Quick facts

Lead sponsor	Handok Inc.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	22 June 2020
Primary completion	8 January 2024
Estimated completion	9 January 2025
Sites	4 locations across South Korea

Drugs / interventions tested

CTX-009 (ABL001) — full drug profile →
Paclitaxel — full drug profile →
Irinotecan (irinotecan) — full drug profile →

Conditions studied

P1b: Advanced Solid Tumors — all drugs for P1b: Advanced Solid Tumors →
P2: Biliary Tract Cancer — all drugs for P2: Biliary Tract Cancer →

Sponsor

Handok Inc. — full company profile →

Who can join

19 and older, any sex, with P1b: Advanced Solid Tumors or P2: Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.

Publications & conference data

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

Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
Molecular Mechanisms and Future Implications of VEGF/VEGFR in Cancer Therapy.
Patel SA, Nilsson MB, Le X, Cascone T, et al · · 2023 · cited 321× · PMID 35969170 · DOI 10.1158/1078-0432.ccr-22-1366
Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
Recent advances and challenges of bispecific antibodies in solid tumors.
Wu Y, Yi M, Zhu S, Wang H, et al · · 2021 · cited 64× · PMID 34922633 · DOI 10.1186/s40164-021-00250-1
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
Role of the ABL tyrosine kinases in the epithelial-mesenchymal transition and the metastatic cascade.
Luttman JH, Colemon A, Mayro B, Pendergast AM. · · 2021 · cited 26× · PMID 34022881 · DOI 10.1186/s12964-021-00739-6
Angiogenesis and targeted therapy in the tumour microenvironment: From basic to clinical practice.
Yang S, Fang Y, Ma Y, Wang F, et al · · 2025 · cited 22× · PMID 40268524 · DOI 10.1002/ctm2.70313

Verify or expand the search:

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04492033 (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 Handok Inc.
Last refreshed: 27 January 2025

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/NCT04492033.

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