NCT03976050 is a Phase 1 clinical trial of HL-085 in Solid Tumor, Adult, sponsored by Shanghai Kechow Pharma, Inc..

Who is sponsoring NCT03976050?

NCT03976050 is sponsored by Shanghai Kechow Pharma, Inc..

What drugs are being tested in NCT03976050?

Interventions in NCT03976050: HL-085.

What condition does NCT03976050 study?

NCT03976050 studies Solid Tumor, Adult.

Is NCT03976050 still recruiting?

NCT03976050 is currently terminated. Last updated 18 November 2020.

Last reviewed 2020-11-18 · How we verify

NCT03976050

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

Phase I Study of HL-085 in Patients With Advanced Solid Tumors

Terminated Phase 1 Last updated 18 November 2020

What this trial tests

Phase 1 trial testing HL-085 in Solid Tumor, Adult in 4 participants. Terminated before completion.

Timeline

17 June 2019

Primary endpoint
12 November 2020

12 November 2020

Quick facts

Lead sponsor	Shanghai Kechow Pharma, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	17 June 2019
Primary completion	12 November 2020
Estimated completion	12 November 2020
Sites	2 locations across United States

Drugs / interventions tested

HL-085 — full drug profile →

Conditions studied

Solid Tumor, Adult — all drugs for Solid Tumor, Adult →

Sponsor

Shanghai Kechow Pharma, Inc. — full company profile →

Who can join

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

Sponsor's own description

The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily. The purposes of this study is to find answers to the following research questions: 1. What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis? 2. What are the side effects of HL-085? 3. How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Neurofibromatosis in the Era of Precision Medicine: Development of MEK Inhibitors and Recent Successes with Selumetinib.
Galvin R, Galvin R, Watson AL, Largaespada DA, et al · · 2021 · cited 19× · PMID 33721151 · DOI 10.1007/s11912-021-01032-y

Verify or expand the search:

Other trials of HL-085

Trials testing the same drug.

NCT05233332 — Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC) · Phase 2 · unknown
NCT05331105 — HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas · Phase 2 · recruiting
NCT05263453 — HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation · Phase 2 · unknown
NCT04683354 — Study of HL-085 in Patients With Advanced Solid Tumor Tumors · Phase 1 · completed
NCT05217303 — HL-085 in NRAS-mutated Advanced Melanoma · Phase 2 · completed

Other recruiting trials for Solid Tumor, Adult

Currently open trials in the same condition.

NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
NCT06398418 — R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients · Phase 1 · recruiting
NCT06682793 — A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumor · Phase 1, PHASE2 · recruiting
NCT07137195 — Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei) · NA · active not recruiting
NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting

Other Shanghai Kechow Pharma, Inc. trials

Trials by the same sponsor.

NCT06008106 — Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma · Phase 3 · recruiting
NCT06008119 — Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Phase 3 · recruiting
NCT05900219 — Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase · Phase 2 · unknown
NCT05233332 — Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC) · Phase 2 · unknown
NCT05331105 — HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas · Phase 2 · recruiting

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 NCT03976050 (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 Shanghai Kechow Pharma, Inc.
Last refreshed: 18 November 2020

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/NCT03976050.

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