Phase 1 / 2 Study Evaluating MCLA-129 in Advanced NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merus B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Sep 2021 → ongoing

Decision date (initial)

2024-10-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514461-19-00

EudraCT number

2021-000203-20

ClinicalTrials.gov

NCT04868877

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Pharmacodynamic, Safety, Efficacy

1. To determine the Objective Response Rate
2. To characterize safety and tolerability of single-agent MCLA-129 and MCLA-129 in combination with chemotherapy and osimertinib
3. To characterize the PK of MCLA-129
4. To evaluate antitumor activity in terms of progression free survival (PFS) and duration of response (DOR)
5. To evaluate Overall Survival

Conditions and MedDRA coding

Solid Tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Signed informed consent form (ICF) before initiation of any study procedures
2. Age ≥18 years at signing of ICF
3. Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate cardiac and organ function
6. Life expectancy ≥ 12 weeks, as per Investigator.

Exclusion criteria 7

1. Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry
2. History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents
3. Uncontrolled hypertension with appropriate treatment, or unstable angina
4. History of clinically significant cardiovascular disease
5. History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for at least 3 years
6. Patients with a history of interstitial lung disease (ILD)
7. Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-129.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Objective Response Rate (ORR)
2. Frequency and severity of adverse events, serious adverse events, treatment discontinuations and modifications
3. Pharmacokinetic parameters (CEOI, Cmax, C0h, AUC, CL, Vss, tmax and t1/2,) and population pharmacokinetics
4. Progression-Free Survival (PFS) and Duration of Response (DOR)
5. Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merus B.V.

Sponsor organisation

Merus B.V.

Address

Floor 3rd And 4th, Uppsalalaan 17 Uppsalalaan 17

City

Utrecht

Postcode

3584 CT

Country

Netherlands

Scientific contact point

Organisation

Merus B.V.

Contact name

Project Physician

Public contact point

Organisation

Merus B.V.

Contact name

Project Physician

Third parties 4

Locations

6 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications