Solid Tumours Harboring NRG1 FusionPhase 2NCT02912949
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
A Phase 2 study testing zenocutuzumab (MCLA-128) in people with Solid Tumours Harboring NRG1 Fusion and NSCLC Harboring NRG1 Fusion, run by Partner Therapeutics, Inc. at 64 sites in 18 countries.
Trial summary
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion
- What is being tested?
- zenocutuzumab (MCLA-128)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 64 sitesin 18 countries
- Study dates
- Jan 2015to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 15) in Group H;
- Performance status of ECOG 0 - 2;
- Estimated life expectancy of at least 12 weeks;
- Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1;
- Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128:
- more than 14 days or more than 5 half-lives prior to study entry, whichever is shorter.
Show all 18Show fewer
- more than 14 days for radiotherapy.
- Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;
- Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for at least 7 days prior to screening;
- Platelets ≥75 x 109/L without transfusion support for at least 7 days prior to screening;
- Hemoglobin ≥8 g/dL or ≥5 mmol/L;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed;
- Estimated glomerular filtration rate (GFR) of more than 30 mL/min
- Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 month after completion of study therapy;
- Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy or no satisfactory alternative treatment options are available;
- Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories.
Who cannot join
- Pregnant or lactating;
- Presence of an active uncontrolled infection or an unexplained fever;
- Known hypersensitivity to any of the components of MCLA-128;
- Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C; patients treated for Hepatitis C and have undetectable viral loads are eligible
- Known symptomatic or unstable brain metastases;
- Patients with leptomeningeal metastases;
Show all 9Show fewer
- Presence of LVEF below 50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to screening, congestive heart failure (NYHA Class III or IV), or ventricular arrhythmia requiring medication;
- Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative intent more than 2 years prior to study entry;
- Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
Trial locations and contacts
64 sites in 18 countries.
64 sites in 18 countries
United States26 sites
Emory Winship Cancer Institute
Atlanta, Georgia
Billings Clinic Cancer Center
Billings, Montana
Dana Farber Cancer Center
Boston, Massachusetts
St. James Healthcare
Butte, Montana
The Oncology Institute of Hope and Innovation
Cerritos, California
Karmanos Cancer Center
Detroit, Michigan, 48201
Hematology-Oncology Specialist of Fredericksburg
Fredericksburg, Virginia
Memorial Cancer Institute
Hollywood, Florida
The University of Texas MD Anderson Cancer Center
Houston, Texas
University of California Irvine
Irvine, California
Cancer Specialists of North Florida
Jacksonville, Florida
Mayo Clinic
Jacksonville, Florida
Memorial Sloan Kettering Cancer Center
New York, New York
Stanford University
Palo Alto, California
University of Pennsylvania
Philadelphia, Pennsylvania
Mayo Clinic
Phoenix, Arizona
Mayo Clinic
Rochester, Minnesota
Northwest Oncology & Hematology
Rolling Meadows, Illinois
Huntsman Cancer Institute
Salt Lake City, Utah
Utah Cancer Specialists
Salt Lake City, Utah
Sharp Memorial Hospital
San Diego, California
Virginia Mason Hospital & Seattle Medical Center
Seattle, Washington
Averra Medical Group
Sioux Falls, South Dakota
Hematology Oncology Associates
Spokane, Washington
Northwest Medical Specialties
Tacoma, Washington
Georgetown University
Washington D.C., District of Columbia
Spain6 sites
Vall D'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
START Hospital Fundación Jiménez Diaz
Madrid, 28040
START Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Hospital 12 de Octubre
Madrid
Clínica Universidad de Navarra
Pamplona
Instituto Valenciano Oncologia
Valencia
France5 sites
Centre Leon Berard
Lyon
Hospital Louis Pradel, FR
Lyon
Institut Gustave Roussy
Paris, 94805
Hopital Cochin
Paris
Hopital Curie
Paris
Japan4 sites
National Cancer Center Hospital
Chūōku
St. Marianna University School of Medicine Hospital
Kawasaki
Osaka International Cancer Institute
Osaka
National Cancer Center East
Tokyo
Germany3 sites
Asklepios Klinik Altona
Hamburg
Asklepios Kliniken Hamburg GmbH
Hamburg
Deutsches Krebsforschungszentrum
Heidelberg
Italy3 sites
Niguarda Cancer Centre
Milan, 20162
Ospedale San Raffaele
Milan
Istituti Fisioterapici Ospitalieri
Roma
Netherlands3 sites
NKI
Amsterdam, 1066 CX
Amsterdam Medical Center
Amsterdam
Radboud University Medical Center
Nijmegen
South Korea3 sites
Samsung Medical Center
Seoul
Seoul National University College of Medicine
Seoul
Severance Hospital- Yonsei Cancer Center
Seoul
Israel2 sites
Shaare Zedek Medical Center
Jerusalem
Sheba Medical Center
Tel Aviv
Singapore1 site
National Cancer Centre of Singapore PTE LTD
Singapore, Singapore
About this study
Official title: A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)
Read the detailed description
Study Design :
This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. Part 1 has been completed.
Part 2 new patient populations examine:
- Group F: Patients with NSCLC with documented NRG1 fusion
- Group G: Patients with pancreatic adenocarcinoma with documented NRG1 fusion
For these new patient populations, Part 2 will further characterize the safety and tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 24 weeks in duration). For the new patient populations, overall response rate (ORR) and duration of response (DOR) will be described.
The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of study drug); Treatment period (treatment cycles of 28 days); and Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years). Participants safety will be monitored throughout the study.
- Conditions
- Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion
- Being tested
- zenocutuzumab (MCLA-128)
- Keywords
- Bispecific Antibody IgG1, HER2, HER3, MCLA-128, Antibodies, Bispecific, Immunologic Factors, NRG1 fusion, Solid tumor, Pancreatic cancer, PDAC, Non-small cell lung cancer, NSCLC, zenocutuzumab
- Medical subject headings
- Lethal Congenital Contracture Syndrome 2, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zenocutuzumab (MCLA-128)Drug
Also called bispecific, MCLA-128
full length IgG1 bispecific antibody targeting HER2 and HER3
| Study group | Role | What they receive |
|---|---|---|
| Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion | Experimental | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. Receives: Drug: zenocutuzumab (MCLA-128) |
| Part 2 NSCLC cancer harboring NRG1 fusion | Experimental | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. Receives: Drug: zenocutuzumab (MCLA-128) |
| Part 2 Solid tumour (basket) harboring NRG1 fusion | Experimental | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. Receives: Drug: zenocutuzumab (MCLA-128) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective overall response rate (ORR) as per local investigator's assessment
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
Measured: 36 months
Duration of response per RECIST v1.1 as per local Investigator's assessment.
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
Measured: 36 Months
Secondary outcomes (17)
Overall response rate as per Blinded Independent Central Review (BICR)
Assess the anti-tumor response of zenocutuzumab (MCLA-128) by RECIST v1.1 as assessed centrally
Measured: 36 months
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and BICR
CBR assessed as the proportion of patients in whom a complete response (CR) or partial response (PR) or stable disease (SD) is observed (where SD duration is a minimum of 24 weeks) by RECIST v1.1 .
Measured: 36 months
Duration of Response as per BICR
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed centrally
Measured: 36 months
Time to response per RECIST v1.1. as per local investigator assessment
To assess time to onset of response in patients with NRG1 fusions as assessed locally
Measured: 36 months
Time to response per RECIST v1.1. as per BICR
To assess time to onset of response in patients with NRG1 fusions as assessed centrally
Measured: 36 months
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: 6-12 months
Maximum plasma concentration [Cmax]
Assess the Cmax of zenocutuzumab (MCLA-128)
Measured: 36 months
Volume of distribution [V]
Assess the volume of distribution of zenocutuzumab (MCLA-128)
Measured: 36 months
Volume of distribution at steady state [Vss]
Assess the volume of distribution of zenocutuzumab (MCLA-128) at steady state
Measured: 36 months
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Assess the Area under the concentration versus time curve from time zero to time t [AUC0-t] of zenocutuzumab (MCLA-128)
Measured: 36 months
half-life [t1/2]
Assess the half-life of zenocutuzumab (MCLA-128)
Measured: 36 months
area under the concentration versus time curve [AUC0-∞]
Assess the area under the concentration versus time curve [AUC0-∞] of zenocutuzumab (MCLA-128)
Measured: 36 months
time to reach maximum concentration [tmax]
Assess the time to reach maximum concentration [tmax] of zenocutuzumab (MCLA-128)
Measured: 36 months
Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Assess the Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Measured: 36 months
serum titers of anti-drug antibodies
Assess serum titers of anti-drug antibodies
Measured: 36 months
Evaluation of progression free survival (PFS)
Measured: 36 months
Evaluation of overall survival (OS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid Tumours Harboring NRG1 FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Partner Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Schram, MD, Principal investigator, Memorial Sloan Kettering Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912949
- Sponsor's protocol ID
- MCLA-128-CL01
- Other IDs
- 2014-003277-42, 2014
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2016
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleary JM, Springfeld C, Arnold D, Hollebecque A, Gbolahan O, Nagasaka M, Siena S, Opdam F, Sunakawa Y, Cassier PA, Trikha G, Gort EH, Florou V, Greil R, La Porte PF, Gandhi PJ, Garner F, Wasserman E, Adeyemi S, Schram AM. Efficacy and Tolerability of Zenocutuzumab in Advanced NRG1 Fusion-Positive Cholangiocarcinoma: Results From the eNRGy Phase II Trial. J Clin Oncol. 2026 Oct 20;44(30):2908-2918. doi: 10.1200/JCO-25-03128. Epub 2026 Jul 1.
PubMed 42385125Schram AM, Goto K, Kim DW, Macarulla T, Hollebecque A, O'Reilly EM, Ou SI, Rodon J, Rha SY, Nishino K, Duruisseaux M, Park JO, Neuzillet C, Liu SV, Weinberg BA, Cleary JM, Calvo E, Umemoto K, Nagasaka M, Springfeld C, Bekaii-Saab T, O'Kane GM, Opdam F, Reiss KA, Joe AK, Wasserman E, Stalbovskaya V, Ford J, Adeyemi S, Jain L, Jauhari S, Drilon A; eNRGy Investigators. Efficacy of Zenocutuzumab in NRG1 Fusion-Positive Cancer. N Engl J Med. 2025 Feb 6;392(6):566-576. doi: 10.1056/NEJMoa2405008.
PubMed 39908431Kim DW, Schram AM, Hollebecque A, Nishino K, Macarulla T, Rha SY, Duruisseaux M, Liu SV, Al Hallak MN, Umemoto K, Wesseler C, Cleary JM, Springfeld C, Neuzillet C, Joe A, Jauhari S, Ford J, Goto K. The phase I/II eNRGy trial: Zenocutuzumab in patients with cancers harboring NRG1 gene fusions. Future Oncol. 2024;20(16):1057-1067. doi: 10.2217/fon-2023-0824. Epub 2024 Feb 13.
PubMed 38348690
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)
- ClinicalTrials.gov ID
- NCT02912949
- Acronym / sponsor ID
- MCLA-128-CL01
- Conditions
- Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion
- Keywords
- Bispecific Antibody IgG1, HER2, HER3, MCLA-128, Antibodies, Bispecific, Immunologic Factors, NRG1 fusion, Solid tumor, Pancreatic cancer, PDAC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Partner Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)
Detailed description
Study Design :
This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. Part 1 has been completed.
Part 2 new patient populations examine:
- Group F: Patients with NSCLC with documented NRG1 fusion
- Group G: Patients with pancreatic adenocarcinoma with documented NRG1 fusion
For these new patient populations, Part 2 will further characterize the safety and tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 24 weeks in duration). For the new patient populations, overall response rate (ORR) and duration of response (DOR) will be described.
The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of study drug); Treatment period (treatment cycles of 28 days); and Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years). Participants safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion | Experimental | Drug: zenocutuzumab (MCLA-128)Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
| Part 2 NSCLC cancer harboring NRG1 fusion | Experimental | Drug: zenocutuzumab (MCLA-128)Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
| Part 2 Solid tumour (basket) harboring NRG1 fusion | Experimental | Drug: zenocutuzumab (MCLA-128)Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 15) in Group H;
- Performance status of ECOG 0 - 2;
- Estimated life expectancy of at least 12 weeks;
- Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1;
- Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128:
Key exclusion criteria (9 listed)
- Pregnant or lactating;
- Presence of an active uncontrolled infection or an unexplained fever;
- Known hypersensitivity to any of the components of MCLA-128;
- Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C; patients treated for Hepatitis C and have undetectable viral loads are eligible
- Known symptomatic or unstable brain metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zenocutuzumab (MCLA-128)Also: bispecific, MCLA-128full length IgG1 bispecific antibody targeting HER2 and HER3 | Drug | Part 2 NSCLC cancer harboring NRG1 fusion, Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion, Part 2 Solid tumour (basket) harboring NRG1 fusion |
Primary outcome
Objective overall response rate (ORR) as per local investigator's assessment
Time frame: 36 months
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
Duration of response per RECIST v1.1 as per local Investigator's assessment.
Time frame: 36 Months
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
17 secondary outcomes
Overall response rate as per Blinded Independent Central Review (BICR)
Time frame: 36 months
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and BICR
Time frame: 36 months
Duration of Response as per BICR
Time frame: 36 months
Time to response per RECIST v1.1. as per local investigator assessment
Time frame: 36 months
Time to response per RECIST v1.1. as per BICR
Time frame: 36 months
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Time frame: 6-12 months
Maximum plasma concentration [Cmax]
Time frame: 36 months
Volume of distribution [V]
Time frame: 36 months
Volume of distribution at steady state [Vss]
Time frame: 36 months
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Time frame: 36 months
half-life [t1/2]
Time frame: 36 months
area under the concentration versus time curve [AUC0-∞]
Time frame: 36 months
time to reach maximum concentration [tmax]
Time frame: 36 months
Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Time frame: 36 months
serum titers of anti-drug antibodies
Time frame: 36 months
Evaluation of progression free survival (PFS)
Time frame: 36 months
Evaluation of overall survival (OS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 42385125Cleary JM, Springfeld C, Arnold D, Hollebecque A, Gbolahan O, Nagasaka M, Siena S, Opdam F, Sunakawa Y, Cassier PA, Trikha G, Gort EH, Florou V, Greil R, La Porte PF, Gandhi PJ, Garner F, Wasserman E, Adeyemi S, Schram AM. Efficacy and Tolerability of Zenocutuzumab in Advanced NRG1 Fusion-Positive Cholangiocarcinoma: Results From the eNRGy Phase II Trial. J Clin Oncol. 2026 Oct 20;44(30):2908-2918. doi: 10.1200/JCO-25-03128. Epub 2026 Jul 1.
- Derived from this study: PubMed 39908431Schram AM, Goto K, Kim DW, Macarulla T, Hollebecque A, O'Reilly EM, Ou SI, Rodon J, Rha SY, Nishino K, Duruisseaux M, Park JO, Neuzillet C, Liu SV, Weinberg BA, Cleary JM, Calvo E, Umemoto K, Nagasaka M, Springfeld C, Bekaii-Saab T, O'Kane GM, Opdam F, Reiss KA, Joe AK, Wasserman E, Stalbovskaya V, Ford J, Adeyemi S, Jain L, Jauhari S, Drilon A; eNRGy Investigators. Efficacy of Zenocutuzumab in NRG1 Fusion-Positive Cancer. N Engl J Med. 2025 Feb 6;392(6):566-576. doi: 10.1056/NEJMoa2405008.
- Derived from this study: PubMed 38348690Kim DW, Schram AM, Hollebecque A, Nishino K, Macarulla T, Rha SY, Duruisseaux M, Liu SV, Al Hallak MN, Umemoto K, Wesseler C, Cleary JM, Springfeld C, Neuzillet C, Joe A, Jauhari S, Ford J, Goto K. The phase I/II eNRGy trial: Zenocutuzumab in patients with cancers harboring NRG1 gene fusions. Future Oncol. 2024;20(16):1057-1067. doi: 10.2217/fon-2023-0824. Epub 2024 Feb 13.
- For more information about MCLA-128 and the MCLA-128-CL01 studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Schram, MD principal investigator
Memorial Sloan Kettering Medical Center
64 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zenocutuzumab (MCLA-128) in people with Solid Tumours Harboring NRG1 Fusion and NSCLC Harboring NRG1 Fusion, run by Partner Therapeutics, Inc. at 64 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Spain, France, Japan, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective overall response rate (ORR) as per local investigator's assessment (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.