A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors
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|ClinicalTrials.gov Identifier: NCT04198818|
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : September 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Tumors Melanoma Non-Small-Cell Lung Cancer Erdheim-Chester Disease Other RAS/RAF/MEK/ERK Mutated Tumors||Drug: HH2710||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients With Advanced Tumors|
|Actual Study Start Date :||January 7, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Dose escalaltion study of HH2710
to determin the MTD of HH2710 and/or Recommended Phase II dose (RP2D).
HH2710 is a small molecule that potently inhibits both ERK1 and ERK2 protein kinases in the nanomolar range. The kinase selectivity assessment towards a panel of over 400 protein kinases showed that HH2710 barely inhibited other kinases at a concentration up to 1 μM, except the substantial inhibition against ERK1 (MAPK1), ERK2 (MAPK2) and the MAPK pathway upstream kinases MEK and RAF proteins.
- MTD (Maximum Tolerated Dose) [ Time Frame: About 2 years ]To determine the maximum tolerable dose.
- DLT (Dose limiting toxicities) [ Time Frame: About 2 years ]Incidence rate of dose limiting toxicities.
- Tumor Objective Response Rate (ORR) [ Time Frame: About 2 years ]Tumor objective response rate (ORR) based on RECIST version 1.1.
- Pharmacokinetic measures - Peak plasma concentration (Cmax) [ Time Frame: About 2 years ]Measure the maximum (peak) plasma concentration(s)
- Pharmacokinetic measures - Peak time (Tmax) [ Time Frame: About 2 years ]Measure of time to reach maximum (peak) plasma concentration(s)
- Pharmacokinetic measures - Plasma concentration timecurve from time 0 to time (t) (AUC0-t) [ Time Frame: About 2 years ]Measure the variation of concentration in blood plasma as a function of time
- Pharmacokinetic measures -Plasma elimination half-life (t1/2) [ Time Frame: About 2 years ]Measure elimination half-life, when administered in combination
- Pharmacokinetic measures - Plasma clearance rate constant (λz), [ Time Frame: About 2 years ]Measure the clearance rate constant
- Pharmacokinetic measures - Apparent clearance (CL/F) [ Time Frame: About 2 years ]Measure apparent total clearance(s) from plasma after oral
- Pharmacokinetic measures - Apparent volume of distribution (Vz/F) [ Time Frame: About 2 years ]Measure apparent volume of distribution during terminal phase after
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): NCT04198818
|Contact: Harb Wael Abou, M.D.||765-446-5111||Wharb@horizonbioadvance.com|
|United States, Indiana|
|Horizon Oncology Research, LLC||Recruiting|
|Lafayette, Indiana, United States, 47905|
|Contact: Albany Costantine, MD firstname.lastname@example.org|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Anthony F. Shields, M.D.,PH.D. 313-576-8735 email@example.com|
|Shanghai East hospital||Recruiting|
|Contact: Jin Li, M.D. +86-021-38804518 ext 22229 firstname.lastname@example.org|
|Principal Investigator: Jin Li, M.D.|