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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04683354
Study type	Interventional
Source	Shanghai Kechow Pharma, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	December 23, 2020
Completion date	December 8, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04551885` - FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors	Phase 1
Completed	`NCT05054348` - First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors	Phase 1
Active, not recruiting	`NCT04474470` - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer	Phase 1/Phase 2
Recruiting	`NCT06088004` - Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT05055609` - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors	Phase 1
Completed	`NCT04020185` - Safety and Efficacy Study of IMSA101 in Refractory Malignancies	Phase 1/Phase 2
Withdrawn	`NCT05071846` - MVX-ONCO-2 in Advanced Solid Tumors	Phase 1
Recruiting	`NCT05607199` - A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics	Phase 1
Active, not recruiting	`NCT04552288` - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies	Phase 2
Active, not recruiting	`NCT06026254` - A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial	Phase 1
Recruiting	`NCT06032845` - Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Solid Tumors (CASTLE-11)	Phase 2
Recruiting	`NCT06144671` - GT201 Injection For The Treatment Of Advanced Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06398418` - R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors	Phase 1
Recruiting	`NCT05276284` - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy	Phase 1/Phase 2
Recruiting	`NCT04121442` - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04221204` - A Monotherapy in Subjects With Advanced Solid Tumors	Phase 1
Terminated	`NCT03992326` - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors	Phase 1
Terminated	`NCT05435339` - A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy	Phase 1/Phase 2
Recruiting	`NCT04981119` - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting	`NCT06075849` - Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent	Phase 1