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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369286
• Other study ID #: MAX-40279-008
• Status: Recruiting
• Phase: Phase 1
• Start date: April 11, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2022
• Source: Maxinovel Pty., Ltd.
• Contact: Hanying MD Bao, Ph.D
• Phone: +86-021-51370693
• Email: hybao[@]maxinovel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• "MAX-40279-01" and "Toripalimab"
"MAX-40279-01"combined with "Toripalimab"

Locations

Country	Name	City	State
China	Institute of The Sixth Affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maxinovel Pty., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLTs	Dose limiting toxicity	21 days
Primary	Incidence of Treatment-Emergent Adverse Events	Safety and tolerability assessed by incidence and severity of adverse events	24 months
Secondary	Subsequent clinical recommended dose	Subsequent clinical recommended dose	12 months
Secondary	Cmax	Maximum plasma drug concentration of Max-40279	Approximately 6 months
Secondary	Tmax	Time to maximum plasma concentration of Max-40279	Approximately 6 months
Secondary	AUC	Area under the time-concentration curve of Max-40279	Approximately 6 months
Secondary	T1/2	Half-life of Max-40279	Approximately 6 months
Secondary	The blood concentration of toripalimab	The blood concentration of toripalimab	Approximately 6 months
Secondary	ADA	Anti-drug antibody of toripalimab	6 months
Secondary	The efficacy end points: ORR?DCR,PFS,DOR,OS	Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival	24 months
Secondary	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	24 months