Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
Mythic Therapeutics (Voir sur ClinicalTrials)
mars 2023
décembre 2027
05 novembre 2024
This is a Phase I open label multi-center study to evaluate the safety, tolerability,
pharmacokinetics and preliminary effectiveness of the investigational drug MYTX-011 in
patients with locally advanced, recurrent or metastatic NSCLC. MYTX-011 is in a class of
medications called antibody drug conjugates (ADCs). MYTX-011 is composed of a
pH-dependent anti-cMET antibody and the potent antimicrotubule drug monomethyl auristatin
E (MMAE).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:11 | Contacter | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hopital de la Timone - Marseille - France | Laurent Greillier, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - Lyon - France | Aurelie Swalduz, MD | Contact (sur clinicalTrials) | |||
| Gustave Roussy Institute - Villejuif - France | Annas Gazza, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié-Bordeaux - Bordeaux - France | Antoine Italiano, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest (ICO institute)-St Herblain - Nantes - France | Judith Raimbourg | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Regaud, IUCT-Oncopole - Toulouse - France | Julien mazieres | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
Inclusion Criteria:
- 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
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)
Inclusion Criteria:
- 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
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