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Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer
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).
Study details:
The study will be conducted in 2 parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify the dose to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations, populations with a current unmet medical need.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-23
Primary completion: 2025-12-01
Study completion finish: 2027-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05652868
Intervention or treatment
DRUG: MYTX-011
Conditions
- • NSCLC
- • Non-Small Cell Lung Cancer
- • NSCLC Stage IV
- • NSCLC Stage IIIB
- • Advanced Non-Small Cell Squamous Lung Cancer
- • Advanced Non-Small Cell Lung Cancer
- • Advanced Non-Small Cell Non-Squamous Lung Cancer
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Cancer Research SA
Adelaide, South Australia, Australia
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?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part 1 Dose Escalation
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort A
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort B
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort C
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort D
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort E
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort B2
| DRUG: MYTX-011
|
EXPERIMENTAL: Part 2 Cohort E2
| DRUG: MYTX-011
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Part 1: Number of patients with dose limiting toxicity (DLT) | The dose limiting toxicities will be based on number and severity of treatment-related adverse events. | Up to Day 21 |
Part 2: Number of patients with tumor response | The overall response rate will be based on number of complete responses and partial responses. | 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Part 1: Pharmacokinetic (PK) parameter (Total ADC) | Total ADC | 24 months |
Part 1: Pharmacokinetic (PK) parameter (Total antibody) | Total antibody | 24 months |
Part 1: Pharmacokinetic (PK) parameter (Free MMAE) | Free MMAE | 24 months |
Part 1: ADA | Presence of anti-drug antibodies | 24 months |
Part 1: ORR | Complete response + partial response | 24 months |
Part 1: DOR, TTR, DCR | Duration of response in patients that achieve CR or PR, time to response, best overall response and disease control rate | 2 years |
Part 1: PFS | Progression free survival | for up to 2 years after end of treatment |
Part 1: OS | Overall survival | for up to 2 years after end of treatment |
Frequently Asked Questions
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