NCT04683354

Study of HL-085 in Patients With Advanced Solid Tumor Tumors

Completed Phase 1 Last updated 13 February 2023

What this trial tests

Phase 1 trial testing HL-085 in Solid Tumor, Adult in 28 participants. Completed in 8 December 2022.

Timeline

23 December 2020

Primary endpoint
15 September 2022

8 December 2022

Quick facts

Lead sponsor	Kechow Pharma, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	23 December 2020
Primary completion	15 September 2022
Estimated completion	8 December 2022
Sites	5 locations across United States

Drugs / interventions tested

• HL-085 — full drug profile →

Conditions studied

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

Sponsor

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 investigational product (IP) HL-085 is an adenosine triphosphate-noncompetitive mitogen activated protein kinase (MEK) inhibitor with a strong selective anti-tumor activity, with a much lower dose than selumetinib. It has been shown strong anti-tumor activities in preclinical studies to treat solid tumors, e.g., melanoma, non-small cell lung cancer, colon cancer and other malignancies with RAF and RAS mutations.

Kechow has completed phase I dose escalation study to test HL-085 in patients with advanced NRAS mutated melanoma in China. The tested doses were 0.5 mg, 1mg, 2mg, 3mg, 4mg, 6mg, 9mg, 12mg, 15mg and 18mg BID oral administration and there was no dose-limiting toxicity (DLT) identified. All patients tolerated the study drug reasonably well.

This study is a Phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetic (PK) and preliminary antitumor activities of HL-085 in US patients with advanced solid tumors. The objective of the dose escalation is to evaluate safety and tolerability of selected TID and BID dose regimens in US patient population with advanced solid tumor and establish the Recommended Phase 2 Dose (RP2D).

The starting dose for this trial is 12 mg daily oral administration. Three selected daily doses - 12 mg (4mg TID, 6mg BID), 18 mg (6mg TID, 9 mg BID), and 24 mg (8 mg TID, 12 mg BID) will be tested in this study to assess safety and tolerability of HL-085 at the 3 selected dose levels in US patient population with advanced solid tumors.

Publications & conference data

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

1. Preclinical characterization of tunlametinib, a novel, potent, and selective MEK inhibitor.
   Liu Y, Cheng Y, Huang G, Xia X, et al · · 2023 · cited 5× · PMID 37808191 · DOI 10.3389/fphar.2023.1271268