Phase I Study of HL-085 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03976050|
Recruitment Status : Terminated (Study objective and design change)
First Posted : June 5, 2019
Last Update Posted : November 18, 2020
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:
- 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?
- What are the side effects of HL-085?
- How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: HL-085||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||June 17, 2019|
|Actual Primary Completion Date :||November 12, 2020|
|Actual Study Completion Date :||November 12, 2020|
Experimental: Dose escalation
Subjects in the dose escalation cohorts will receive ascending doses of HL-085 until the MTD is determined. The first three subjects will receive twice-daily doses (BID) of HL-085 6 mg. Additional cohorts may receive doses of HL-085 9, 12 or 18 mg BID respectively and sequentially. If DLTs are observed in <33.3% of subjects at the 18 mg dose.
HL-085 is a MEK inhibitor with potential indication for cancers. it will be given twice 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 anti-tumor 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.
Other Name: No other interventions
- Adverse events (AEs) [ Time Frame: Duration of the study, estimated to be approximately 24 months. ]An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Dose limitation toxicities (DLT) [ Time Frame: During Cycle 1 (the first 28 days) ]
A DLT is defined as the occurrence of any of the following AE considered possibly, probably, or definitely related to the IP, HL-085, by the Investigator and/or the Sponsor that occurs during Cycle 1 as described in below:
- Any death not clearly due to the underlying disease or extraneous causes; or
- Non-hematologic toxicities Grade 3 or higher.
- Grade 3 thrombocytopenia with clinically significant bleeding, or other hematologic toxicity at Grade 4 or above.
- Neutropenic fever
- liver parameter abnormalities
- Any toxicity requiring permanent discontinuation of the IP
- Maximum tolerated dose (MTD) [ Time Frame: MTD will be determined when DLT occurs in great or equal to 33.3% of the same cohort subjects during During Cycle 1 (the first 28 days) ]MTD is defined as the highest dose level at which DLT occurs in less than 33.3% of subjects.
- cMAX [ Time Frame: Duration of the study, estimated to be approximately 24 months ]cMAX is the maximum plasma concentration of HL-085 or metabolite(s).
- Overall response rate (ORR) [ Time Frame: Duration of the study, estimated to be approximately 24 months ]ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed per response evaluation criteria in solid tumors (RECIST) v1.1.
- pERK expression [ Time Frame: Duration of the study, estimated to be approximately 24 months ]Correlation between phosphorylated extracellular-signal-regulated kinase (pERK) expression and efficacy endpoints.
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): NCT03976050
|United States, Texas|
|Livestrong Cancer Institute, Dell Medical School, The University of Texas at Austin|
|Austin, Texas, United States, 78712|
|San Antonio, Texas, United States, 78229|
|Study Director:||Yi Liu, MD, PhD||KeChow Pharma|