Solid TumorPhase 1NCT05369286
A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors
A Phase 1 study testing "MAX-40279-01" and "Toripalimab" in people with Solid Tumor, run by Maxinovel Pty., Ltd. at 1 site in China.
Trial summary
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- "MAX-40279-01" and "Toripalimab"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2022to 31 Aug 2023
- Phase
- Phase 1
- 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 75 years
- 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 solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- 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.5.0) 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of The Sixth Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510000
xiangen Lu, 020-38379764, zslyllb@mail.sysu.edu.cn
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.
Read the detailed description
This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.
- Conditions
- Solid Tumor
- Being tested
- "MAX-40279-01" and "Toripalimab"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"MAX-40279-01" and "Toripalimab"Drug
"MAX-40279-01"combined with "Toripalimab"
| Study group | Role | What they receive |
|---|---|---|
| dose level 1 of max-40279 combined dose level 1 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" Receives: Drug: "MAX-40279-01" and "Toripalimab" |
| dose level 2 of max-40279 combined dose level 1 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" Receives: Drug: "MAX-40279-01" and "Toripalimab" |
| dose level 2 of max-40279 combined dose level 2 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" Receives: Drug: "MAX-40279-01" and "Toripalimab" |
| dose level 3 of max-40279 combined dose level 2 of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" Receives: Drug: "MAX-40279-01" and "Toripalimab" |
| recommend dose of max-40279 combined recommend dose level of toripalimab | Experimental | "MAX-40279-01" and "toripalimab" Receives: Drug: "MAX-40279-01" and "Toripalimab" |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Dose limiting toxicity
Measured: 21 days
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 24 months
Secondary outcomes (9)
Subsequent clinical recommended dose
Subsequent clinical recommended dose
Measured: 12 months
Cmax
Maximum plasma drug concentration of Max-40279
Measured: Approximately 6 months
Tmax
Time to maximum plasma concentration of Max-40279
Measured: Approximately 6 months
AUC
Area under the time-concentration curve of Max-40279
Measured: Approximately 6 months
T1/2
Half-life of Max-40279
Measured: Approximately 6 months
The blood concentration of toripalimab
The blood concentration of toripalimab
Measured: Approximately 6 months
ADA
Anti-drug antibody of toripalimab
Measured: 6 months
The efficacy end points: ORR、DCR，PFS，DOR，OS
Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival
Measured: 24 months
the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors
the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors
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 posted11 May 2022
- Study start11 Apr 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiangen MD Lu, Ph.D, Study chair, Institute of The Sixth Affiliated Hospital Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369286
- Sponsor's protocol ID
- MAX-40279-008
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05369286
- Acronym / sponsor ID
- MAX-40279-008
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 May 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.
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.
Detailed description
This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose level 1 of max-40279 combined dose level 1 of toripalimab | Experimental | Drug: "MAX-40279-01" and "Toripalimab""MAX-40279-01" and "toripalimab" |
| dose level 2 of max-40279 combined dose level 1 of toripalimab | Experimental | Drug: "MAX-40279-01" and "Toripalimab""MAX-40279-01" and "toripalimab" |
| dose level 2 of max-40279 combined dose level 2 of toripalimab | Experimental | Drug: "MAX-40279-01" and "Toripalimab""MAX-40279-01" and "toripalimab" |
| dose level 3 of max-40279 combined dose level 2 of toripalimab | Experimental | Drug: "MAX-40279-01" and "Toripalimab""MAX-40279-01" and "toripalimab" |
| recommend dose of max-40279 combined recommend dose level of toripalimab | Experimental | Drug: "MAX-40279-01" and "Toripalimab""MAX-40279-01" and "toripalimab" |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- Signed informed consent form.
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.5.0) 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-40279-01" and "Toripalimab""MAX-40279-01"combined with "Toripalimab" | Drug | dose level 1 of max-40279 combined dose level 1 of toripalimab, dose level 2 of max-40279 combined dose level 1 of toripalimab, dose level 2 of max-40279 combined dose level 2 of toripalimab, dose level 3 of max-40279 combined dose level 2 of toripalimab, recommend dose of max-40279 combined recommend dose level of toripalimab |
Primary outcome
DLTs
Time frame: 21 days
Dose limiting toxicity
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 months
Safety and tolerability assessed by incidence and severity of adverse events
9 secondary outcomes
Subsequent clinical recommended dose
Time frame: 12 months
Cmax
Time frame: Approximately 6 months
Tmax
Time frame: Approximately 6 months
AUC
Time frame: Approximately 6 months
T1/2
Time frame: Approximately 6 months
The blood concentration of toripalimab
Time frame: Approximately 6 months
ADA
Time frame: 6 months
The efficacy end points: ORR、DCR，PFS，DOR，OS
Time frame: 24 months
the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors
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 11 May 2022.
- 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.
xiangen MD Lu, Ph.D study chair
Institute of The Sixth Affiliated Hospital Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing "MAX-40279-01" and "Toripalimab" in people with Solid Tumor, 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 5 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 11 May 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 MD Bao, 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?
DLTs (time frame: 21 days). 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 11 May 2022.