Study of HL-085 in Patients With Advanced Solid Tumor Tumors
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|ClinicalTrials.gov Identifier: NCT04683354|
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : March 18, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: HL-085||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Multi-Center Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||December 23, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Dose Escalation
There are 3 cohorts for the dose escalation study. Six subjects each cohort will receive oral administration of HL-085 capsules at three daily dose levels (12 mg, 18 mg and 24 mg). Three subjects of each cohort will receive TID and 3 subjects will receive BID dose regimen. Dose escalation can occur after 6 patients have completed 28 days of treatment and no or 1 DLT is identified.
HL-085 is a MEK inhibitor with potential indication for cancers. It will be given twice or three times daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative antitumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.
- Characterize the safety profile of the study drug at 3 dose levels in terms of number of treatment emergent events assessed by CTCAE v5.0., abnormal clinical laboratory and electrocardiograms findings (i.e. QT and QTc intervals). [ Time Frame: 7 months (6 months treatment + 1 month follow-up) ]
- Cmax: the maximum plasma concentration of HL-085 or metabolite(s); [ Time Frame: 1 month (Cycle 1 Day 1-31) ]
- Tmax: the time of Cmax; [ Time Frame: 1 month (Cycle 1 Day 1-31) ]
- Area under the curve at steady state: a measure of the exposure to HL-085 or metabolite(s) at steady state. [ Time Frame: 1 month (Cycle 1 Day 1-31) ]
- Evaluate the efficacy of the study drug in terms of overall response rate, progression-free survival. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed per RECIST v1.1. [ Time Frame: 7 months (6 months treatment + 1 month follow-up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683354
|Contact: Tong Salsedo, MBAfirstname.lastname@example.org|
|United States, California|
|San Marcos, California, United States, 92069|
|Contact: Edward McClay, MD|
|United States, Nevada|
|Comprehensive Cancer Centers||Recruiting|
|Las Vegas, Nevada, United States, 89169|
|Contact: Fadi Braiteh, MD|
|United States, Ohio|
|Gabrail Cancer Center||Recruiting|
|Canton, Ohio, United States, 44718|
|Contact: Nashat Gabrail, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Meredith McKean, MD|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Contact: Julio Peguero, MD|
|Study Director:||Hongqi Tian, PhD||Kechow Pharma, Inc.|