CRCPhase 2mCRCNCT05233332
Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)
A Phase 2 study testing HL-085 and Vemurafenib in people with CRC, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
Trial summary
The study consists of the two parts, phase IIa and phase IIb. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CRC
- What is being tested?
- HL-085 and Vemurafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2022to 20 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Oncology Hospital
Beijing, Beijing Municipality
About this study
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)
The study consists of the two parts, phase IIa and phase IIb.
Read the detailed 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.
- Conditions
- CRC
- Being tested
- HL-085, Vemurafenib
- Keywords
- metastatic colorectal cancer (mCRC), HL-085, Vemurafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-085Drug
12mg BID HL-085
VemurafenibDrug
Also called ZELBORAF
720mg BID Vemurafenib
| Study group | Role | What they receive |
|---|---|---|
| phase IIa: HL-085 in Subjects With BRAF V600E-Mutated CRC | Experimental | 12mg BID HL-085 Receives: Drug: HL-085 |
| phase IIa: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC | Experimental | 12mg BID HL-085+720mg BID Vemurafenib Receives: 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 Receives: 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 Receives: Drug: HL-085; Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 12 months
Secondary outcomes (8)
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
Measured: up to 12 months
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
Measured: up to 12 months
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
Measured: up to 12 months
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
Measured: up to 12 months
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
Measured: up to 12 months
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
Measured: up to 12 months
OS
OS is defined as the time from the date of taking drugs to the date of death due to any cause
Measured: up to 24 months
Number of Adverse Events
Number of Treatment-Related Adverse Events as Assessed by CTCAE v5.0 will be counted
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start24 Feb 2022
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongqi Tian, Ph.D, Study director, Shanghai Kechow Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233332
- Sponsor's protocol ID
- HL-085-201
- Acronym
- mCRC
- Status last verified
- May 2023
- First submitted
- 21 Jan 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05233332
- Acronym / sponsor ID
- mCRC / HL-085-201
- Conditions
- CRC
- Keywords
- metastatic colorectal cancer (mCRC), HL-085, Vemurafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consists of the two parts, phase IIa and phase IIb.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| phase IIa: HL-085 in Subjects With BRAF V600E-Mutated CRC | Experimental | Drug: HL-08512mg BID HL-085 |
| phase IIa: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC | Experimental | Drug: HL-085, Drug: Vemurafenib12mg BID HL-085+720mg BID Vemurafenib |
| phase IIa: HL-085+Vemurafenib in Subjects With RAS or other BRAF-Mutated or MEK1/2-Mutated CRC | Experimental | Drug: HL-085, Drug: Vemurafenib12mg BID HL-085+720mg BID Vemurafenib |
| phase IIb: HL-085+Vemurafenib in Subjects With BRAF V600E-Mutated CRC | Experimental | Drug: HL-085, Drug: Vemurafenib12mg BID HL-085+720mg BID Vemurafenib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL-08512mg BID HL-085 | Drug | 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 |
| VemurafenibAlso: ZELBORAF720mg BID Vemurafenib | Drug | 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 |
Primary outcome
ORR（by investigator）
Time frame: up to 12 months
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
ORR（by ICR）
Time frame: up to 12 months
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
8 secondary outcomes
PFS（by investigator）
Time frame: up to 12 months
PFS（by ICR）
Time frame: up to 12 months
DOR（by investigator）
Time frame: up to 12 months
DOR（by ICR）
Time frame: up to 12 months
DCR（by investigator）
Time frame: up to 12 months
DCR（by ICR）
Time frame: up to 12 months
OS
Time frame: up to 24 months
Number of Adverse Events
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongqi Tian, Ph.D study director
Shanghai Kechow Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL-085 and Vemurafenib in people with CRC, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimei Zhu, Master (86 215201345822, zhuzm@kechowpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（by investigator） (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.