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A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05369286
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Maxinovel Pty., Ltd.

Study Description
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Brief Summary:
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: "MAX-40279-01" and "Toripalimab" Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : August 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: dose level 1 of max-40279 combined dose level 1 of toripalimab
"MAX-40279-01" and "toripalimab"
 Drug: "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"
Experimental: dose level 2 of max-40279 combined dose level 1 of toripalimab
"MAX-40279-01" and "toripalimab"
 Drug: "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"
Experimental: dose level 2 of max-40279 combined dose level 2 of toripalimab
"MAX-40279-01" and "toripalimab"
 Drug: "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"
Experimental: dose level 3 of max-40279 combined dose level 2 of toripalimab
"MAX-40279-01" and "toripalimab"
 Drug: "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"
Experimental: recommend dose of max-40279 combined recommend dose level of toripalimab
"MAX-40279-01" and "toripalimab"
 Drug: "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"


Outcome Measures
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Primary Outcome Measures :
  1. DLTs [ Time Frame: 21 days ]
    Dose limiting toxicity

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 24 months ]
    Safety and tolerability assessed by incidence and severity of adverse events


Secondary Outcome Measures :
  1. Subsequent clinical recommended dose [ Time Frame: 12 months ]
    Subsequent clinical recommended dose

  2. Cmax [ Time Frame: Approximately 6 months ]
    Maximum plasma drug concentration of Max-40279

  3. Tmax [ Time Frame: Approximately 6 months ]
    Time to maximum plasma concentration of Max-40279

  4. AUC [ Time Frame: Approximately 6 months ]
    Area under the time-concentration curve of Max-40279

  5. T1/2 [ Time Frame: Approximately 6 months ]
    Half-life of Max-40279

  6. The blood concentration of toripalimab [ Time Frame: Approximately 6 months ]
    The blood concentration of toripalimab

  7. ADA [ Time Frame: 6 months ]
    Anti-drug antibody of toripalimab

  8. The efficacy end points: ORR、DCR，PFS，DOR，OS [ Time Frame: 24 months ]
    Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival

  9. the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors [ Time Frame: 24 months ]
    the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and/or females over age 18
  2. Histologically and/or cytologically documented local advanced or metastatic solid tumor.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. Expected survival >3 months.
  5. Signed informed consent form.

Exclusion Criteria:

  1. Known uncontrolled or symptomatic central nervous system metastatic disease.
  2. 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.
  3. Inadequate organ or bone marrow function.
  4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
  5. Pregnant or breast-feeding woman.
  6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05369286


Contacts
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Contact: Hanying MD Bao, Ph.D +86-021-51370693 hybao@maxinovel.com

Locations
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China, Guangdong
Institute of The Sixth Affiliated Hospital Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: xiangen Lu    020-38379764    zslyllb@mail.sysu.edu.cn   
Sponsors and Collaborators
Maxinovel Pty., Ltd.
Investigators
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Study Chair: xiangen MD Lu, Ph.D Institute of The Sixth Affiliated Hospital Sun Yat-sen University
More Information
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Responsible Party: Maxinovel Pty., Ltd.
ClinicalTrials.gov Identifier: NCT05369286    
Other Study ID Numbers: MAX-40279-008
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms