NCT02442414 is a Phase 1 clinical trial of KBP-5209 in Advanced Solid Tumors, sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

Who is sponsoring NCT02442414?

NCT02442414 is sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

What drugs are being tested in NCT02442414?

Interventions in NCT02442414: KBP-5209.

What condition does NCT02442414 study?

NCT02442414 studies Advanced Solid Tumors.

Is NCT02442414 still recruiting?

NCT02442414 is currently completed. Last updated 4 March 2022.

Last reviewed 2022-03-04 · How we verify

NCT02442414

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

A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 4 March 2022

What this trial tests

Phase 1 trial testing KBP-5209 in Advanced Solid Tumors in 35 participants. Completed in 26 November 2019.

Timeline

7 April 2015

Primary endpoint
26 November 2019

26 November 2019

Quick facts

Lead sponsor	Sihuan Pharmaceutical Holdings Group Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	7 April 2015
Primary completion	26 November 2019
Estimated completion	26 November 2019
Sites	3 locations across United States

Drugs / interventions tested

KBP-5209 — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd. — 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

The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Publications & conference data

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

Genomic <i>ERBB2</i>/<i>ERBB3</i> mutations promote PD-L1-mediated immune escape in gallbladder cancer: a whole-exome sequencing analysis.
Li M, Liu F, Zhang F, Zhou W, et al · · 2019 · cited 143× · PMID 29954840 · DOI 10.1136/gutjnl-2018-316039
Overview of current targeted therapy in gallbladder cancer.
Song X, Hu Y, Li Y, Shao R, et al · · 2020 · cited 123× · PMID 33028805 · DOI 10.1038/s41392-020-00324-2
A literature review of recent advances in gastric cancer treatment: exploring the cross-talk between targeted therapies.
Panahizadeh R, Panahi P, Asghariazar V, Makaremi S, et al · · 2025 · cited 7× · PMID 39856676 · DOI 10.1186/s12935-025-03655-8

Verify or expand the search:

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 Sihuan Pharmaceutical Holdings Group Ltd. trials

Trials by the same sponsor.

NCT04622072 — XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer · Phase 1 · terminated
NCT04476394 — Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/ · Phase 1 · unknown
NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
NCT04215653 — A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 3 · unknown
NCT04200261 — Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects · Phase 1 · unknown

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 NCT02442414 (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 Sihuan Pharmaceutical Holdings Group Ltd.
Last refreshed: 4 March 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/NCT02442414.

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