Metastatic Colorectal CancerPhase 2NCT05130021
A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer
A Phase 2 study testing MAX-40279-01 and regorafenib in people with Metastatic Colorectal Cancer, run by Maxinovel Pty., Ltd. at 1 site in China.
Trial summary
This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- MAX-40279-01 and regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2022to 31 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
- Signed informed consent form.
Who cannot join
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.
- Inadequate organ or bone marrow function.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yanhong Deng, Dr, +86 13925106525, 13925106525@163.com
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.
Read the detailed description
This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- MAX-40279-01, regorafenib
- Keywords
- metastatic colorectal cancer, pretreated
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-40279-01Drug
MAX-40279-01 50mg/70mg
regorafenibDrug
regorafenib
| Study group | Role | What they receive |
|---|---|---|
| Part 1;50mg | Experimental | Not described Receives: Drug: MAX-40279-01 |
| Part 1;70mg | Experimental | Not described Receives: Drug: MAX-40279-01 |
| Part 2;MAX-40279-01 | Experimental | Not described Receives: Drug: MAX-40279-01 |
| Part 2;regorafenib | Experimental | Not described Receives: Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)[Part 1]
Measured: Through study Part 1 completion, an average of 6 months
progress free survival(PFS)[Part 2]
Measured: Through study Part 1 completion, an average of 6 months
Secondary outcomes (6)
Tmax
Time to maximum plasma concentration
Measured: Approximately 6 months
Cmax
Maximum plasma drug concentration
Measured: Approximately 6 months
AUC
Area under the time-concentration curve
Measured: Approximately 6 months
Objective response rate (ORR)
Measured: 6 months (anticipated)
overall survival (OS)
Measured: 24 months
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start31 Jan 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130021
- Sponsor's protocol ID
- MAX-40279-005
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05130021
- Acronym / sponsor ID
- MAX-40279-005
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, pretreated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 Nov 2021 (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.
This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.
Detailed description
This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1;50mg | Experimental | Drug: MAX-40279-01 |
| Part 1;70mg | Experimental | Drug: MAX-40279-01 |
| Part 2;MAX-40279-01 | Experimental | Drug: MAX-40279-01 |
| Part 2;regorafenib | Experimental | Drug: regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
Key exclusion criteria (6 listed)
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.
- Inadequate organ or bone marrow function.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| MAX-40279-01MAX-40279-01 50mg/70mg | Drug | Part 1;50mg, Part 1;70mg, Part 2;MAX-40279-01 |
| regorafenibregorafenib | Drug | Part 2;regorafenib |
Primary outcome
Disease control rate (DCR)[Part 1]
Time frame: Through study Part 1 completion, an average of 6 months
progress free survival(PFS)[Part 2]
Time frame: Through study Part 1 completion, an average of 6 months
6 secondary outcomes
Tmax
Time frame: Approximately 6 months
Cmax
Time frame: Approximately 6 months
AUC
Time frame: Approximately 6 months
Objective response rate (ORR)
Time frame: 6 months (anticipated)
overall survival (OS)
Time frame: 24 months
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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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.
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 MAX-40279-01 and regorafenib in people with Metastatic Colorectal Cancer, run by Maxinovel Pty., Ltd. 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 6 inclusion and 6 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 6 Dec 2021. 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 Hanying Bao, MD,Ph.D (+86-021-51370693, hybao@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR)[Part 1] (time frame: Through study Part 1 completion, an average of 6 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 6 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.