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

June 16, 2022 updated by: Maxinovel Pty., Ltd.

A I / II Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetic Characteristics and Efficacy of MAX-40279 (Multi-target Tyrosine Kinase Inhibitor) Combined With KN046 (Anti-PD-L1 / CTLA-4 Bispecific Antibody) in Patients With Advanced / Metastatic Solid Tumors

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a study of MAX-40279 in patients with advanced / metastatic solid tumors. This study include two Parts, the Part 1 will assess the safety and efficacy of the dose climbing level of MAX-40279, and recommend a dose extending level of MAX-40279 for stage 2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent form.
  2. Males and/or females over age 18 and 75.
  3. 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
  4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  6. Expected survival of more than 3 months.

Exclusion Criteria:

  1. 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)
  2. Subject is known to have previous serious allergic reactions to macromolecular protein preparations/monoclonal antibodies, or known to any component of the test drug
  3. Active systemic infectious diseases requiring intravenous antibiotic treatment 2 months before the first medication
  4. 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
  5. 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
  6. Patients who have experienced ≥ grade 3 immune-related adverse events in immunotherapy (except grade 3 hypothyroidism that can be controlled by drugs)
  7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MAX40279-01+KN046

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
[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.
Other Names:
  • KN046: 40mg/300mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
DLT
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
ORR
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
PFS
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
Adverse events (AEs), serious adverse events (SAEs)
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
laboratory tests
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
vital signs
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
12 ECG
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
physical examination abnormalities
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events (AEs), serious adverse events (SAEs)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
Cmax
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
Anti-KN046 antibody (ADA
Time Frame: through study Stage1 completion，an average of 6 months
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]
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
(AUC0-t and AUC0-t, ss)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
Tmax
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
Overall response rate (ORR)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
disease control rate (DCR)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
duration of response (DOR)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
progression-free survival (PFS)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
overall survival (OS)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
DcR
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
DoR
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
OS
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
Anti-KN046 antibody (ADA)
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months
Rac (AUC0-t, ss/AUC0-t)
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
laboratory tests
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
vital signs
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
12 ECG
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months
physical examination abnormalities
Time Frame: through study Stage1 completion，an average of 6 months
through study Stage1 completion，an average of 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
FGFR1OP2-related protein expression levels and mutations, PD-L1 and related inflammatory factors correlate with efficacy [Stage 1]
Time Frame: through study Stage1 completion，an average of 6 months
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]
Time Frame: through study Stage2 completion，an average of 24 months
through study Stage2 completion，an average of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maxinovel Pty., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAX-40279-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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