Health TrialsbyHealthPanel

Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.

ConditionNon-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

This is a multi-center, open-label, phase II clinical study of MCLA-129 as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification to evaluate the efficacy, safety, pharmacokinetic characteristics of MCLA-129.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects are ≥ 18 years of age, regardless of gender.

Subjects must have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.

Subjects must have measurable lesions that meet the definition of RECIST v1.1. Selected target lesions must meet one of the following two criteria: 1) no prior local therapy or radiation or 2) subsequent progression occurs within the prior local therapy area as determined by RECIST v1.1..

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Disqualifiers

Have received an investigational product or antitumor drug treatment (including known anti-tumor traditional Chinese medicine treatment) within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer) (for a drug with a long half-life, it is required that the interval from the last dose to be at most 4 weeks; for chemotherapy with delayed toxicity, such as nitrosourea or mitomycin C, it shall be 6 weeks before [the treatment]).

Have undergone a major surgery and radiotherapy (local palliative radiotherapy is allowed 2 weeks or more prior to the first dose) within 4 weeks prior to the first dose of MCLA-129.

Have previously received systemic anti-tumor therapy beyond the fourth line (excluding maintenance therapy).

Prior use of EGFR/c-Met bispecific antibody or ADC drugs (Amivantamab [JNJ-61186372], EMB-01, GB263T, PM1080/HS-20117, TAVO412, YH013/DM005, AZD9592, or SHR-9839).

Trial design

Design model

Parallel

Treatments tested in this trial

  • MCLA-129

    Drug

    MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

To evaluate the efficacy of MCLA-129 at RP2D in patients with advanced NSCLC and other solid tumors in each cohort in Part 2 in terms of overall response rate (ORR)

Time frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years

Secondary outcomes

1

Clinical benefit rate (CBR)

To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of clinical benefit rate (CBR).

Time frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
2

Disease Control Rate (DCR)

To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of disease control rate (DCR)

Time frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
3

Progression-Free Survival (PFS)

To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of progression-free survival (PFS).

Time frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
4

Duration of Response (DOR)

To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of duration of response (DOR).

Time frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Betta Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: