Status:
UNKNOWN
A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors
Lead Sponsor:
Maxinovel Pty., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 prese...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05369286
Start Date
April 11 2022
End Date
August 31 2023
Last Update
May 11 2022
Active Locations (1)
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1
Institute of The Sixth Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, China, 510000