A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors

NCT05425602 | Unknown Phase 1

• 1 other identifier: MAX-40279-007
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.

Conditions

Advanced / Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (9)

• DLT

  through study Stage1 completion，an average of 6 months

• Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)

  through study Stage1 completion，an average of 6 months

• ORR

  through study Stage2 completion，an average of 24 months

• PFS

  through study Stage2 completion，an average of 24 months

• Adverse events (AEs), serious adverse events (SAEs)

  through study Stage2 completion，an average of 24 months

• laboratory tests

  through study Stage2 completion，an average of 24 months

• vital signs

  through study Stage2 completion，an average of 24 months

• 12 ECG

  through study Stage2 completion，an average of 24 months

• physical examination abnormalities

  through study Stage2 completion，an average of 24 months

Secondary Outcomes (20)

• Adverse events (AEs), serious adverse events (SAEs)

  through study Stage1 completion，an average of 6 months

• Cmax

  through study Stage1 completion，an average of 6 months

• Anti-KN046 antibody (ADA

  through study Stage1 completion，an average of 6 months

• Duration of response (DOR) Overall survival (OS); Anti-KN046 antibody (ADA); Plasma concentrations of MAX-40279 and KN046 [Stage 2]

  through study Stage2 completion，an average of 24 months

• (AUC0-t and AUC0-t, ss)

  through study Stage1 completion，an average of 6 months

Other Outcomes (2)

• FGFR1OP2-related protein expression levels and mutations, PD-L1 and related inflammatory factors correlate with efficacy [Stage 1]

  through study Stage1 completion，an average of 6 months

• FGFR1OP2-related protein expression levels and correlation of mutations, PD-L1, tumor mutation burden, and related inflammatory factors with efficacy.[ Stage 2]

  through study Stage2 completion，an average of 24 months

Study Arms (1)

MAX40279-01+KN046

EXPERIMENTAL

This is an open-label Phase I/II clinical study. Drug: Stage1: Dose1:MAX40279-01 (35mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage1: Dose2:MAX40279-01( 50mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage1: Dose3:MAX40279-01( 70mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage2: Dose3:MAX40279-01( RP2D BID)+KN046 ( 5mg/kg Q3Week)

Drug: MAX-40279-01: 50mg/70mg

Interventions

MAX-40279-01: 50mg/70mg DRUG

\[Stage 1\]The starting dose of MAX-40279 was 35 mg BID, and three dose levels were initially set: 35 mg, 50 mg, and 70 mg administered twice daily (BID) continuously, and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks. \[Stage 2\]When the RP2D dose is obtained in the dose-finding phase, the trial will enter the dose expansion phase.

Also known as: KN046: 40mg/300mg

MAX40279-01+KN046

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Males and/or females over age 18 and 75.
• Histologically or cytologically documented local advanced / metastatic solid tumors who have failed standard treatment or cannot obtain standard treatment in the dose escalation stage; dose expansion stage group A: relapsed and refractory advanced gastric cancer; dose expansion stage group B: relapsed and refractory extensive stage small cell lung cancer; dose expansion stage group C: other relapsed and refractory solid tumors except group A
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival of more than 3 months.

You may not qualify if:

• The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other adverse reactions without safety risks judged by the investigator)
• Subject is known to have previous serious allergic reactions to macromolecular protein preparations/monoclonal antibodies, or known to any component of the test drug
• Active systemic infectious diseases requiring intravenous antibiotic treatment 2 months before the first medication
• Subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: such as: (1) NYHA class II or higher heart failure or LVEF \< 50%; (2) unstable angina pectoris; (3) myocardial infarction and cerebral infarction within 6 months; (4) clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without clinical intervention or clinical intervention
• brain metastases, spinal cord compression, carcinomatous meningitis with clinical symptoms, or other evidence of uncontrolled brain and spinal cord metastases, Patients who are not suitable by the investigator's judgment
• Patients who have experienced ≥ grade 3 immune-related adverse events in immunotherapy (except grade 3 hypothyroidism that can be controlled by drugs)
• Patients who have other malignant tumors within 5 years before enrollment,Exceptions: a. radical cervical carcinoma in situ or non-melanoma skin cancer; b. radical second primary cancer without recurrence within five years; c. the investigator believes that the double primary cancer can benefit from this study; d. the investigator has clearly excluded which primary tumor source the metastasis

Sponsors & Collaborators

• Maxinovel Pty., Ltd.: lead

Central Study Contacts

Ting Peng, MD,Ph.D

CONTACT

13917659695; tpeng@maxinovel.com

Zhengbo Song, MD,Ph.D

CONTACT

0571-88122168; songzb@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: June 21, 2022
• Study Start: July 31, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share