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Advanced / Metastatic Solid TumorsPhase 1/2NCT05425602

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

A Phase 1/2 study testing MAX-40279-01: 50mg/70mg in people with Advanced / Metastatic Solid Tumors, run by Maxinovel Pty., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced / Metastatic Solid Tumors
What is being tested?
MAX-40279-01: 50mg/70mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
31 Jul 2022to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ting Peng, MD,Ph.D contact

13917659695

tpeng@maxinovel.com

Zhengbo Song, MD,Ph.D contact

0571-88122168

songzb@zjcc.org.cn

About this study

Official title: 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.

Read the 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.

Being tested
MAX-40279-01: 50mg/70mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAX-40279-01: 50mg/70mgDrug

    Also called KN046: 40mg/300mg

    [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.

Study groups in NCT05425602
Study groupRoleWhat they receive
MAX40279-01+KN046ExperimentalThis 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)
Receives: Drug: MAX-40279-01: 50mg/70mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Measured: through study Stage1 completion，an average of 6 months

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

    Measured: through study Stage1 completion，an average of 6 months

  3. ORR

    Measured: through study Stage2 completion，an average of 24 months

  4. PFS

    Measured: through study Stage2 completion，an average of 24 months

  5. Adverse events (AEs), serious adverse events (SAEs)

    Measured: through study Stage2 completion，an average of 24 months

  6. laboratory tests

    Measured: through study Stage2 completion，an average of 24 months

  7. vital signs

    Measured: through study Stage2 completion，an average of 24 months

  8. 12 ECG

    Measured: through study Stage2 completion，an average of 24 months

  9. physical examination abnormalities

    Measured: through study Stage2 completion，an average of 24 months

Secondary outcomes (20)

  1. Adverse events (AEs), serious adverse events (SAEs)

    Measured: through study Stage1 completion，an average of 6 months

  2. Cmax

    Measured: through study Stage1 completion，an average of 6 months

  3. Anti-KN046 antibody (ADA

    Measured: through study Stage1 completion，an average of 6 months

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

    Measured: through study Stage2 completion，an average of 24 months

  5. (AUC0-t and AUC0-t, ss)

    Measured: through study Stage1 completion，an average of 6 months

  6. Tmax

    Measured: through study Stage1 completion，an average of 6 months

  7. Overall response rate (ORR)

    Measured: through study Stage1 completion，an average of 6 months

  8. disease control rate (DCR)

    Measured: through study Stage1 completion，an average of 6 months

  9. duration of response (DOR)

    Measured: through study Stage1 completion，an average of 6 months

  10. progression-free survival (PFS)

    Measured: through study Stage1 completion，an average of 6 months

  11. overall survival (OS)

    Measured: through study Stage1 completion，an average of 6 months

  12. DcR

    Measured: through study Stage2 completion，an average of 24 months

  13. DoR

    Measured: through study Stage2 completion，an average of 24 months

  14. OS

    Measured: through study Stage2 completion，an average of 24 months

  15. Anti-KN046 antibody (ADA)

    Measured: through study Stage2 completion，an average of 24 months

  16. Rac (AUC0-t, ss/AUC0-t)

    Measured: through study Stage1 completion，an average of 6 months

  17. laboratory tests

    Measured: through study Stage1 completion，an average of 6 months

  18. vital signs

    Measured: through study Stage1 completion，an average of 6 months

  19. 12 ECG

    Measured: through study Stage1 completion，an average of 6 months

  20. physical examination abnormalities

    Measured: through study Stage1 completion，an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start31 Jul 2022 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425602
Sponsor's protocol ID
MAX-40279-007
Status last verified
Jun 2022
First submitted
18 Apr 2022
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MAX-40279-01: 50mg/70mg in people with Advanced / Metastatic Solid Tumors, run by Maxinovel Pty., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ting Peng, MD,Ph.D (13917659695, tpeng@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: through study Stage1 completion，an average of 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.

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