Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)

CRC Clinical Trial

— mCRC  

Official title:

A Phase Ⅱ, Multicenter Open-label Study to Investigate the Efficacy and Safety of HL-085 Combined With Vemurafenib in Patients With Metastatic Colorectal Cancer (mCRC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233332
• Other study ID #: HL-085-201
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: July 20, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Kechow Pharma, Inc.
• Contact: Zhimei Zhu, Master
• Phone: 86 215201345822
• Email: zhuzm[@]kechowpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study consists of the two parts, phase IIa and phase IIb.

Description:

The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: July 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent prior to enrollment;
• Adults 18 years of age or older, male or female;
• Histologically- or cytologically-confirmed CRC that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy,or inappropriate for line 1 therapy (for phase ?a); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase ?b);
• Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Life expectancy = 3 months;
• Able to take the medicine orally;
• Adequate bone marrow and organ function.

Exclusion Criteria:

• Prior treatment with any RAS inhibitors, RAF inhibitors, or MEK inhibitors;
• History or screening evidence of retinal diseases;
• Impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases;
• Previous or current neuromuscular diseases that is associated with CK elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
• Impaired liver function, defined as Child-Pugh Class B or C;
• Toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity);
• Use of any medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for CYP1A2 metabolism.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• CRC

Intervention

Drug:
• HL-085
12mg BID HL-085
• Vemurafenib
720mg BID Vemurafenib

Locations

Country	Name	City	State
China	Beijing Oncology Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Kechow Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(by investigator)	Phase IIa:ORR per the RECIST version 1.1,defined as the number of patients achieving an overall best response of CR or partial response (PR) divided by the total number of patients	up to 12 months
Primary	ORR(by ICR)	Phase ?b:ORR per the RECIST version 1.1,defined as the number of patients achieving an overall best response of CR or partial response (PR) divided by the total number of patients	up to 12 months
Secondary	PFS(by investigator)	Phase IIa:PFS,defined as the time from first dose to the earliest documented disease progression or death due to any cause	up to 12 months
Secondary	PFS(by ICR)	Phase IIb:PFS,defined as the time from first dose to the earliest documented disease progression or death due to any cause	up to 12 months
Secondary	DOR(by investigator)	Phase IIa:DOR,Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death	up to 12 months
Secondary	DOR(by ICR)	Phase IIb:DOR,Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death	up to 12 months
Secondary	DCR(by investigator)	Phase IIa:Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death	up to 12 months
Secondary	DCR(by ICR)	Phase IIb:Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death	up to 12 months
Secondary	OS	OS is defined as the time from the date of taking drugs to the date of death due to any cause	up to 24 months
Secondary	Number of Adverse Events	Number of Treatment-Related Adverse Events as Assessed by CTCAE v5.0 will be counted	up to 12 months