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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2024-07-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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CRC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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HL-085

12mg BID HL-085

Intervention Type DRUG

Vemurafenib

720mg BID Vemurafenib

Intervention Type DRUG

Other Intervention Names

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ZELBORAF

Eligibility Criteria

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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 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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No