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Relapsed/Refractory Small Cell Lung CancerPhase 2DeLLphi-301NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 study testing Tarlatamab in people with Relapsed/Refractory Small Cell Lung Cancer, run by Amgen at 80 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main aim of this study is to: evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab for Part 1 only evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
80 sitesin 18 countries
Study dates
1 Dec 2021to 30 Dec 2027
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

  • Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
  • Histologically or cytologically confirmed relapsed/refractory SCLC
  • Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.
  • Participants willing to provide archived tumor tissue samples or willing to undergo pretreatment tumor biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 1.
Show all 9Show fewer
  • Minimum life expectancy of 12 weeks.
  • Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab.
  • Participants with treated brain metastases are eligible provided they meet defined criteria.

Who cannot join

  • Disease Related
  • Untreated or symptomatic brain metastases and leptomeningeal disease.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • Unresolved toxicity from prior anti-tumor therapy, defined as per protocol.
  • Other Medical Conditions
Show all 37Show fewer
  • History of other malignancy within the past 2 years, with exceptions
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of tarlatamab.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.
  • Presence of any indwelling line or drain.
  • History of hypophysitis or pituitary dysfunction.
  • Exclusion of hepatitis infection based on the results and/or criteria per protocol.
  • Major surgery within 28 days of first dose of tarlatamab.
  • History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Subject is eligible if no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of tarlatamab (counted from day of positive test for asymptomatic subjects).
  • Prior/Concomitant Therapy
  • Participant received prior therapy with tarlatamab.
  • Prior anti-cancer therapy within 28 days prior to first dose of tarlatamab.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.
  • The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:
  • Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
  • End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab.
  • Other Exclusions
  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
  • Female participants planning to become pregnant while on study through 60 days after the last dose of tarlatamab.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
  • History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician.
  • Specific Exclusions to Part 3
  • Participants unable to remain within one hour of study site for 48 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.
  • Participants unable to remain within one hour of any hospital for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.
  • Unable to identify home companion who will cohabitate with participant for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.

Trial locations and contacts

80 sites in 18 countries.

80 sites in 18 countries

United States16 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30332

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Dana Farber - Harvard Cancer Center

    Boston, Massachusetts, 02215

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Dartmouth Hitchcock Medical Center

    Hanover, New Hampshire, 03756

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Wake Forest Baptist Comprehensive Cancer Research Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Greece8 sites

  • Henry Dunant Hospital Center

    Athens, 11526

  • Sotiria General Hospital

    Athens, 11527

  • Metropolitan Hospital

    Athens, 18547

  • University Hospital of Heraklion

    Heraklion - Crete, 71500

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335

  • Theagenion Cancer Hospital

    Thessaloniki, 54007

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645

  • Agios Loukas Clinic

    Thessaloniki, 55236

Other trials in Greece

Spain8 sites

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Instituto Catalan de Oncologia Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

France7 sites

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915

  • Institut Curie

    Paris, 75248

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan7 sites

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

South Korea6 sites

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Yonsei University Health System Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung medical center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Portugal5 sites

  • Hospital da Luz, SA

    Lisbon, 1500-650

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

    Porto, 4099-001

  • Hospital Cuf porto

    Porto, 4100-180

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Belgium3 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Grand Hopital de Charleroi - Site Saint Joseph

    Gilly, 6060

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Germany3 sites

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

    Rome, 00144

  • Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Centra Medyczne Medyceusz Sp zoo

    Lodz, 91-053

  • Mazowieckie centrum leczenia

    Otwock, 05-400

Other trials in Poland

Austria2 sites

  • Universitaetsklinikum Krems

    Krems, 3500

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

Other trials in Austria

Netherlands2 sites

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Taiwan2 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

United Kingdom2 sites

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

  • Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

Switzerland1 site

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

The main aim of this study is to:

  • evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab for Part 1 only
  • evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2
  • evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3
Being tested
Tarlatamab
Keywords
Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab, IMDELLTRA^TM
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    Intravenous (IV) infusion

Study groups in NCT05060016
Study groupRoleWhat they receive
Part 1: Tarlatamab Low DoseExperimentalParticipants will receive the low dose of Tarlatamab.
Receives: Drug: Tarlatamab
Part 1: Tarlatamab High DoseExperimentalParticipants will receive the high dose of Tarlatamab.
Receives: Drug: Tarlatamab
Part 2: Dose ExpansionExperimentalParticipants will receive the selected target dose of Tarlatamab based on findings in Part 1.
Receives: Drug: Tarlatamab
Part 3: Modified Monitoring SubstudyExperimentalParticipants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 61 months

  2. Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events

    Measured: Up to a maximum of 61 months

  3. Part 1 Only: Serum Concentrations of Tarlatamab

    Measured: Up to a maximum of 24 months

  4. Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

    Measured: Up to a maximum of 61 months

Secondary outcomes (13)

  1. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

    Measured: Up to a maximum of 73 months

  2. Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

    Measured: Up to a maximum of 73 months

  3. Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

    Measured: Up to a maximum of 73 months

  4. Progression-free Survival (PFS) Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

    Measured: Up to a maximum of 73 months

  5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  6. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  7. Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  8. Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  9. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  10. Overall Survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

    Measured: Up to a maximum of 73 months

  11. Number of Participants who Experience One or More Treatment-emergent Adverse Events

    Measured: Up to a maximum of 73 months

  12. Serum Concentrations of Tarlatamab

    Measured: Up to a maximum of 24 months

  13. Number of Participants who Experience Anti-Tarlatamab Antibody Formation

    Measured: Up to a maximum of 73 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2021
  2. Study start1 Dec 2021
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060016
Sponsor's protocol ID
20200491
Other IDs
2024-511837-37
Acronym
DeLLphi-301
Status last verified
Jul 2026
First submitted
17 Sep 2021
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Expanded access
Available

Publications

  • Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Bustamante Alvarez J, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L; DeLLphi-301 Investigators. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 30;389(22):2063-2075. doi: 10.1056/NEJMoa2307980. Epub 2023 Oct 20.

    PubMed 37861218

  • Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.

    PubMed 39530627

  • Hummel HD, Ahn MJ, Blackhall F, Reck M, Akamatsu H, Ramalingam SS, Borghaei H, Johnson M, Dirnberger F, Cocks K, Huang S, Mukherjee S, Paz-Ares L. Patient-Reported Outcomes for Patients with Previously Treated Small Cell Lung Cancer Receiving Tarlatamab: Results from the DeLLphi-301 Phase 2 Trial. Adv Ther. 2025 Apr;42(4):1950-1964. doi: 10.1007/s12325-025-03136-4. Epub 2025 Mar 3.

    PubMed 40025391

  • Kong S, Minocha M, Chen PW, Martinez P, Anderson ES, Parkes A, Houk BE, Lin CW. Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer. Clin Pharmacokinet. 2025 May;64(5):729-741. doi: 10.1007/s40262-025-01499-z. Epub 2025 Apr 22.

    PubMed 40261494

  • Ahn MJ, Cho BC, Ohashi K, Izumi H, Lee JS, Han JY, Chiang CL, Huang S, Hamidi A, Mukherjee S, Xu KL, Akamatsu H. Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer. Oncol Ther. 2025 Dec;13(4):1041-1054. doi: 10.1007/s40487-025-00372-0. Epub 2025 Sep 4.

    PubMed 40908346

  • Chen PW, Minocha M, Kong S, Jiang T, Anderson ES, Parkes A, Martinez P, Houk BE, Lin CW. Tarlatamab Exposure-Efficacy and Exposure-Safety Relationships to Inform Dose Selection in Patients with Small Cell Lung Cancer. Clin Cancer Res. 2025 Nov 14;31(22):4688-4697. doi: 10.1158/1078-0432.CCR-25-2134.

    PubMed 40928991

  • Dirnberger F, Wang J, King-Kallimanis B, Cocks K, Skingley G, Clarke N, Huang S, Mukherjee S, Koller M. Derivation of Meaningful Change Thresholds for European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-LC13 in Patients With Small-Cell Lung Cancer. Value Health. 2026 Feb;29(2):223-232. doi: 10.1016/j.jval.2025.09.011. Epub 2025 Sep 25.

    PubMed 41015335

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarlatamab in people with Relapsed/Refractory Small Cell Lung Cancer, run by Amgen at 80 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 9 inclusion and 37 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Greece, Spain, France, Japan 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?

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator (time frame: Up to a maximum of 61 months). The study lists 4 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 NCT05060016, which also lists 7 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 22 Jul 2026.

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