Non-Small Cell Lung Cancer MetastaticPhase 1/2NCT04868877
Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination
A Phase 1/2 study testing MCLA-129, Osimertinib and Chemotherapy in people with Non-Small Cell Lung Cancer Metastatic and Gastric Cancer, run by Merus B.V. at 51 sites in 9 countries.
Trial summary
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma
- What is being tested?
- MCLA-129, Osimertinib and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 51 sitesin 9 countries
- Study dates
- 28 Apr 2021to 1 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
- Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
- Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible.
- Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed.
Show all 14Show fewer
- History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
- History of clinically significant cardiovascular disease
- Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD or pneumonitis.
- Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug.
- Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
- Active Hepatitis B infection without receiving antiviral treatment.
- Positive test for Hepatitis C
- Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
Spain13 sites
Hospital HM Delfos
Barcelona, 08023
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
IOB Institute of Oncology - Hospital Quironsalud Barcelona
Barcelona, 8023
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Clínica Universidad de Navarra -Madrid
Madrid, 28027
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Centro Integral Oncológico Clara Campal
Madrid, 28050
Hospital Quirón Madrid
Madrid, 28223
Clínica Universidad de Navarra
Pamplona, 31008
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, 46009
Hospital Universitari i Politècnic La Fe
Valencia, 46026
France12 sites
Clinique de l'Europe
Amiens, 80090
CHU Hopitaux de Bordeaux - Hôpital Saint-André
Bordeaux, 33000
CHU de Lyon - Louis Pradel Hospital
Bron, 69677
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Hôpital Albert Calmette
Lille, 59037
L'Institut Paoli - Calmettes
Marseille, 13009
CHU de Nantes - Hôpital Nord Laennec
Nantes, 44093
Marie Wislez
Paris, 75014
Hôpital Bichat - Claude-Bernard
Paris, 75877
Hôpital Européen Georges Pompidou (HEGP)
Paris, 75908
CHU de Poitiers
Poitiers, 86000
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94163
Italy8 sites
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138
ASST degli Spedali Civili di Brescia
Brescia, 25123
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
ASST Grande Ospedale Metropolitano Niguarda
Milan, 22162
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, 10043
Istituto Nazionale dei Tumori Regina Elena
Roma, Rome, 00144
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
South Korea6 sites
Gachon University Gil Hospital
Incheon, 21565
Samsung Medical Center
Seoul, 6351
Seoul National University Hospital
Seoul
Severance Hospital - Yonsei Cancer Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
United States4 sites
Next Oncology Virginia
Fairfax, Virginia, 22031
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of California, Irvine
Orange, California, 92868
START Mountain Region
West Valley City, Utah, 84119
Netherlands3 sites
Netherlands Cancer Institute
Amsterdam
University Medical Center Groningen
Groningen
Erasmus Medical Center
Rotterdam
Belgium2 sites
Institut Jules Bordet
Anderlecht
Antwerp University Hospital
Edegem, 2650
Germany2 sites
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488
Sana Klinikum Offenbach GmbH
Offenbach, 63069
About this study
Official title: Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.
- Conditions
- Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Being tested
- MCLA-129, Osimertinib, Chemotherapy
- Keywords
- MCLA-129, EGFR inhibitor, NSCLC, C-MET, GC/GEJ, Head and Neck Cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCLA-129Drug
Also called bispecific
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
OsimertinibDrug
Also called Tagrisso
Approved, 3rd-generation EGFR-TKI
ChemotherapyDrug
administrated by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). Receives: Drug: MCLA-129 |
| Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). Receives: Drug: MCLA-129 |
| Part 2 Selected solid tumors with or without an EGFR or cMet alteration | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). Receives: Drug: MCLA-129 |
| Part 2 NSCLC First-line harboring EGFR sensitizing mutations | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. Receives: Drug: MCLA-129; Drug: Osimertinib |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib) | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. Receives: Drug: MCLA-129; Drug: Osimertinib |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy) | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. Receives: Drug: MCLA-129; Drug: Chemotherapy |
| Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy) | Experimental | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. Receives: Drug: MCLA-129; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
Measured: First 28 days of treatment
To evaluate clinical activity, as assessed by ORR
To evaluate the ORR of MCLA-129 monotherapy or in combination with an EGFR TKI or chemotherapy in molecularly defined populations of advanced/metastatic solid tumors.
Measured: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
Secondary outcomes (9)
To evaluate preliminary antitumor activity in terms of BOR
To evaluate preliminary antitumor activity of MCLA-129 monotherapy as well as in combination with an EGFR TKI or chemotherapy in terms of best overall response (BOR)
Measured: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DCR
To evaluate preliminary antitumor activity of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy in terms of Disease Control Rate (DCR).
Measured: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DoR
To evaluate preliminary antitumor activity of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy in terms of Duration of Response (DoR)
Measured: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate progression-free survival (PFS)
To evaluate progression-free survival (PFS) of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Measured: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
To evaluate overall survival (OS)
To evaluate overall survival (OS) of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Measured: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy
Measured: From first dose until study treatment discontinuation
Proportion of patient with treatment discontinuations of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Measured: From first dose until study treatment discontinuation
AE, regardless of relationship to study treatment
Measured: From first dose until study treatment discontinuation
All safety endpoints
including vital sign, lab, ECG, ECHO, 4 weeks CT scan, Eye exam
Measured: From first dose until study treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start28 Apr 2021
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Why it stopped: The Sponsor terminated the trial early for strategic business reasons. This isn't related to any safety/efficacy/clinical activity/benefit-risk concern with petosemtamab. Ongoing participants will have access to treatment outside of this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer MetastaticStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merus B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868877
- Sponsor's protocol ID
- MCLA-129-CL01
- Other IDs
- 2024-514461-19-00
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT04868877
- Acronym / sponsor ID
- MCLA-129-CL01
- Conditions
- Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Keywords
- MCLA-129, EGFR inhibitor, NSCLC, C-MET, GC/GEJ, Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor terminated the trial early for strategic business reasons. This isn't related to any safety/efficacy/clinical activity/benefit-risk concern with petosemtamab. Ongoing participants will have access to treatment outside of this trial.
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Merus B.V.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion | Experimental | Drug: MCLA-129Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation | Experimental | Drug: MCLA-129Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 Selected solid tumors with or without an EGFR or cMet alteration | Experimental | Drug: MCLA-129Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 NSCLC First-line harboring EGFR sensitizing mutations | Experimental | Drug: MCLA-129, Drug: OsimertinibParticipants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib) | Experimental | Drug: MCLA-129, Drug: OsimertinibParticipants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy) | Experimental | Drug: MCLA-129, Drug: ChemotherapyParticipants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. |
| Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy) | Experimental | Drug: MCLA-129, Drug: ChemotherapyParticipants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
- Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
- Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible.
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 |
|---|---|---|
| MCLA-129Also: bispecificfull length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET | Drug | Part 2 NSCLC First-line harboring EGFR sensitizing mutations, Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion, Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation, Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy), Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib), Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy), Part 2 Selected solid tumors with or without an EGFR or cMet alteration |
| OsimertinibAlso: TagrissoApproved, 3rd-generation EGFR-TKI | Drug | Part 2 NSCLC First-line harboring EGFR sensitizing mutations, Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib) |
| Chemotherapyadministrated by IV infusion | Drug | Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy), Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy) |
Primary outcome
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Time frame: First 28 days of treatment
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
To evaluate clinical activity, as assessed by ORR
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate the ORR of MCLA-129 monotherapy or in combination with an EGFR TKI or chemotherapy in molecularly defined populations of advanced/metastatic solid tumors.
9 secondary outcomes
To evaluate preliminary antitumor activity in terms of BOR
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DCR
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DoR
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate progression-free survival (PFS)
Time frame: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
To evaluate overall survival (OS)
Time frame: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy
Time frame: From first dose until study treatment discontinuation
Proportion of patient with treatment discontinuations of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Time frame: From first dose until study treatment discontinuation
AE, regardless of relationship to study treatment
Time frame: From first dose until study treatment discontinuation
All safety endpoints
Time frame: From first dose until study treatment discontinuation
Results and safety
The study was stopped early (reason given: The Sponsor terminated the trial early for strategic business reasons. This isn't related to any safety/efficacy/clinical activity/benefit-risk concern with petosemtamab. Ongoing participants will have access to treatment outside of this trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MCLA-129, Osimertinib and Chemotherapy in people with Non-Small Cell Lung Cancer Metastatic and Gastric Cancer, run by Merus B.V. at 51 sites in 9 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 0 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Spain, France, Italy, South Korea, United States and 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: The Sponsor terminated the trial early for strategic business reasons. This isn't related to any safety/efficacy/clinical activity/benefit-risk concern with petosemtamab. Ongoing participants will have access to treatment outside of this trial.). Results are not available in the source record.
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?
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) (time frame: First 28 days of treatment). 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?
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 26 Oct 2026.