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
17 octobre 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 dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Nicolas Girard, MD | Contact (sur clinicalTrials) | |||
| 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.
- 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.
- 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.
- Tumor sample with cMET overexpression by IHC confirmed by central laboratory
testing.
Cohort D:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not
a candidate for curative therapy), or metastatic NSCLC.
- Tumor sample that does not meet cMET IHC entry criteria for Cohorts A-C
- Known MET amplification or exon 14 skipping mutations respectively. Patients with
MET exon 14 skipping mutations must have received MET TKI therapy if available and
considered standard of care.
Cohort E:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not
a candidate for curative therapy), or metastatic NSCLC.
- Evidence of cMET expression by IHC as documented in medical records.
- No more than 3 prior lines of systemic therapy including prior cMET targeted ADC or
antibody.
Part 2 Cohorts A-D
- No more than two prior lines of therapy in the locally advanced/metastatic setting.
Part 2 Cohorts A-E:
- Known to not have an actionable EGFR mutation. Patients with or without other driver
mutations are permitted to enroll.
- Patients without any actionable gene alteration: must have progressed on (or be
considered ineligible for) standard of care therapy
- Patients with actionable gene alterations (other than EGFR) must have progressed on
(or be considered ineligible for) or be intolerant to anti-cancer therapy targeting
driver gene alterations and available standard of care therapy
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
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.
- 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.
- 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.
- Tumor sample with cMET overexpression by IHC confirmed by central laboratory
testing.
Cohort D:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not
a candidate for curative therapy), or metastatic NSCLC.
- Tumor sample that does not meet cMET IHC entry criteria for Cohorts A-C
- Known MET amplification or exon 14 skipping mutations respectively. Patients with
MET exon 14 skipping mutations must have received MET TKI therapy if available and
considered standard of care.
Cohort E:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not
a candidate for curative therapy), or metastatic NSCLC.
- Evidence of cMET expression by IHC as documented in medical records.
- No more than 3 prior lines of systemic therapy including prior cMET targeted ADC or
antibody.
Part 2 Cohorts A-D
- No more than two prior lines of therapy in the locally advanced/metastatic setting.
Part 2 Cohorts A-E:
- Known to not have an actionable EGFR mutation. Patients with or without other driver
mutations are permitted to enroll.
- Patients without any actionable gene alteration: must have progressed on (or be
considered ineligible for) standard of care therapy
- Patients with actionable gene alterations (other than EGFR) must have progressed on
(or be considered ineligible for) or be intolerant to anti-cancer therapy targeting
driver gene alterations and available standard of care therapy
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
- Radiation to the lung within 2 months prior to screening.
- Major surgery within 28 days of first dose of study drug administration.
- Untreated, uncontrolled CNS metastases.
- 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
- Neuropathy > Grade 1
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other
clinically significant liver disease.
- Active or chronic corneal disorder