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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05652868




Registration number
NCT05652868
Ethics application status
Date submitted
29/11/2022
Date registered
15/12/2022

Titles & IDs
Public title
Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer
Scientific title
A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01
Secondary ID [1] 0 0
KisMET-01
Secondary ID [2] 0 0
MYTX-011-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
NSCLC Stage IV 0 0
NSCLC Stage IIIB 0 0
Non-Small Cell Lung Cancer 0 0
Advanced Non-Small Cell Squamous Lung Cancer 0 0
Advanced Non-Small Cell Lung Cancer 0 0
Advanced Non-Small Cell Non-Squamous Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MYTX-011

Experimental: Part 1 Dose Escalation - Part 1 patients will receive MYTX-011.

Experimental: Part 2 Cohort A - Part 2 Cohort A patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1.

Experimental: Part 2 Cohort B - Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.

Experimental: Part 2 Cohort C - Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.

Experimental: Part 2 Cohort D - Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.

Experimental: Part 2 Cohort E - Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.

Experimental: Part 2 Cohort B2 - Part 2 Cohort B2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1

Experimental: Part 2 Cohort E2 - Part 2 Cohort E2 patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1


Treatment: Drugs: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of patients with dose limiting toxicity (DLT)
Timepoint [1] 0 0
Up to Day 21
Primary outcome [2] 0 0
Part 2: Number of patients with tumor response
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Part 1: Pharmacokinetic (PK) parameter (Total ADC)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Part 1: Pharmacokinetic (PK) parameter (Total antibody)
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Part 1: Pharmacokinetic (PK) parameter (Free MMAE)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Part 1: ADA
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Part 1: ORR
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Part 1: DOR, TTR, DCR
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Part 1: PFS
Timepoint [7] 0 0
for up to 2 years after end of treatment
Secondary outcome [8] 0 0
Part 1: OS
Timepoint [8] 0 0
for up to 2 years after end of treatment

Eligibility
Key inclusion criteria
Part 1:

* Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC and have received available standard of care therapy.
* There is no limit on the number of prior therapies that can have been received.

Part 2:

Cohort A:

* Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation.
* Tumor sample with high cMET expression by IHC confirmed by central laboratory testing.

Cohort B:

* Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation.
* Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing.

Cohort B2

* Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC without EGFR mutation.
* Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing.

Cohort C:

* Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic squamous NSCLC without EGFR mutation.
* Tumor sample with cMET overexpression by IHC confirmed by central laboratory testing.

Cohort D:

* Have histologically or cytologically confirmed locally advanced non-squamous or adenosquamous NSCLC without EGFR mutation.
* Tumor sample with low cMET expression on tumor biopsy confirmed centrally

that does not meet cMET IHC entry criteria for Cohorts A,B, or B2-C

Cohort E:

- curative therapy), or metastatic NSCLC with actionable EGFR mutations

Tumor sample with high or intermediate cMETet expression tumor biopsy confirmed centrally

Must have received an available standard of care therapy and have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting.

Cohort E2

-Have histologically or cytologically confirmed locally advanced, recurrent

(and not a candidate for curative therapy), or metastatic NSCLC with actionable EGFR mutations.

• Tumor sample with high or intermediate cMEet expression tumor biopsy confirmed centrally

Must have received an available standard of care therapy and have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting.

Part 2 Cohorts A-D

1. Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations are permitted to enroll.
2. Must have received available standard of care therapy.
3. Must have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting. Note: multiple lines of TKI for the same actionable mutation count as 1 line of therapy. Maintenance therapy is not considered a separate line of therapy. Adjuvant and neoadjuvant therapies count as 1 line of therapy if given within 6 months before study entry.
4. Subjects without any actionable gene alteration: must have progressed on (or be considered ineligible for), or be intolerant to, platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
5. Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alterations and platinum-based chemotherapy.
6. Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint inhibitor is standard of care: must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alteration and platinum-based chemotherapy, and also progressed on (or be considered ineligible for) or be intolerant to immune checkpoint

All patients (Part 1 and Part 2)



* Patient has at least one measurable lesion per RECIST 1.1
* ECOG performance status 0 or 1
* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective method of birth control for the duration of the study treatment and for at least 6 months after the last dose of study drug.
* Able to provide informed consent, and willing and able to comply with study protocol requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Radiation to the lung within 6 weeks prior to screening. For all other sites (except lung), therapeutic or palliative radiation within 2 weeks prior to the first dose of study drug. Must have recovered from all radiation-related toxicity.

Major surgery within 28 days of first dose of study drug administration.

Untreated, uncontrolled central nervous system (CNS) metastases and/or leptomeningeal disease.

* History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or evidence of active interstitial lung disease or pneumonitis. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Clinically significant systemic illness that could pose undue risk to the subject or confound the ability to interpret study results.
* Active infection requiring IV antibiotics, antivirals, or antifungal medication within 14 Days of Cycle 1 Day 1
* Neuropathy > Grade 1
* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease.
* Active or chronic corneal disorder
* Conditions that may interfere with assessment of vision, such as monocular status or severe visual impairment in 1 or both eyes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
Cancer Research SA - Adelaide
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Nantes
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Toulouse
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
MA
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Busan
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Incheon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seongnam
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Suwon
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Malaga
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Spain
State/province [32] 0 0
Zaragoza
Country [33] 0 0
Taiwan
State/province [33] 0 0
MA
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taichung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Tainan
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Taiwan
State/province [38] 0 0
Zhubei
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Glasgow
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Newcastle
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mythic Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ting Wu, MD MSc
Address 0 0
Mythic Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
William T Downing
Address 0 0
Country 0 0
Phone 0 0
1-833-888-1138
Fax 0 0
Email 0 0
clinicalsupport@mythictx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
At the conclusion of the study
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05652868