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

NCT05233332 | Unknown Phase 2

• 1 other identifier: HL-085-201
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CRC

Keywords

metastatic colorectal cancer (mCRC); HL-085; Vemurafenib

Outcome Measures

Primary Outcomes (2)

• 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

• ORR（by ICR）

  Phase Ⅱb：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 Outcomes (8)

• PFS（by investigator）

  up to 12 months

• PFS（by ICR）

  up to 12 months

• DOR（by investigator）

  up to 12 months

• DOR（by ICR）

  up to 12 months

• DCR（by investigator）

  up to 12 months

Study Arms (4)

phase IIa: HL-085 in Subjects With BRAF V600E-Mutated CRC

EXPERIMENTAL

12mg BID HL-085

Drug: HL-085

phase IIa: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC

EXPERIMENTAL

12mg BID HL-085+720mg BID Vemurafenib

Drug: HL-085; Drug: Vemurafenib

phase IIa: HL-085+Vemurafenib in Subjects With RAS or other BRAF-Mutated or MEK1/2-Mutated CRC

EXPERIMENTAL

12mg BID HL-085+720mg BID Vemurafenib

Drug: HL-085; Drug: Vemurafenib

phase IIb: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC

EXPERIMENTAL

12mg BID HL-085+720mg BID Vemurafenib

Drug: HL-085; Drug: Vemurafenib

Interventions

HL-085 DRUG

12mg BID HL-085

phase IIa: HL-085 in Subjects With BRAF V600E-Mutated CRC; phase IIa: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC; phase IIa: HL-085+Vemurafenib in Subjects With RAS or other BRAF-Mutated or MEK1/2-Mutated CRC; phase IIb: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC

Vemurafenib DRUG

720mg BID Vemurafenib

Also known as: ZELBORAF

phase IIa: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC; phase IIa: HL-085+Vemurafenib in Subjects With RAS or other BRAF-Mutated or MEK1/2-Mutated CRC; phase IIb: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase Ⅱb);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Kechow Pharma, Inc.: lead

Study Sites (1)

Beijing Oncology Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Vemurafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hongqi Tian, Ph.D

  Shanghai Kechow Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Zhimei Zhu, Master

CONTACT

86 215201345822; zhuzm@kechowpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 10, 2022
• Study Start: February 24, 2022
• Primary Completion: January 20, 2024
• Study Completion: July 20, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (1)