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AzTrials

Non-Small Cell Lung CancerPhase 1NCT05029882

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

A Phase 1 study testing ABBV-400, Trifluridine/Tipiracil and Bevacizumab in people with Non-Small Cell Lung Cancer and Advanced Solid Tumors, run by AbbVie at 82 sites in 10 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

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-400, Trifluridine/Tipiracil and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
82 sitesin 10 countries
Study dates
13 Oct 2021to Nov 2027
Phase
Phase 1
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

  • Diagnosis of malignant solid tumor (World Health Organization [WHO] criteria).
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • For Part 2 only - advanced non-squamous squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:
  • Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR NSCLC (Part 2i) and squamous NSCLC (Part 2iii).
  • Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).
Show all 31Show fewer
  • Must have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on
  • If applicable, an immune checkpoint inhibitor.
  • If applicable, appropriate available therapies, including HER2-directed therapies.
  • Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible.
  • For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:
  • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).
  • Oxaliplatin.
  • Irinotecan.
  • If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).
  • If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
  • If applicable, targeted therapy
  • Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102) or Regorafenib treated participants are eligible.
  • For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.
  • For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options.
  • Intolerant to the standard treatment are eligible
  • For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on:
  • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)
  • Oxaliplatin
  • Irinotecan
  • If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab)
  • If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept)
  • If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Laboratory values meeting the criteria outlined in the protocol.

Who cannot join

  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan..
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
  • History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol.
  • For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

Trial locations and contacts

82 sites in 10 countries.

82 sites in 10 countries

United States18 sites

  • University Of Colorado Denver /ID# 231574

    Aurora, Colorado, 80045-2530

  • Duplicate_Gabrail Cancer Center Research /ID# 248419

    Canton, Ohio, 44718

  • University of Illinois Hospital and Health Sciences System /ID# 251386

    Chicago, Illinois, 60607

  • Duke Cancer Institute /ID# 247236

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists - Fairfax /ID# 231575

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338

    Fort Wayne, Indiana, 46825

  • START Midwest /ID# 231551

    Grand Rapids, Michigan, 49546-7062

  • Comprehensive Cancer Centers of Nevada /ID# 242930

    Henderson, Louisiana, 89052

  • MD Anderson Cancer Center at Texas Medical Center /ID# 248656

    Houston, Texas, 77030-4000

  • Oncology Consultants /ID# 267347

    Houston, Texas, 77030

  • Carolina BioOncology Institute /ID# 231541

    Huntersville, North Carolina, 28078

  • Indiana University Melvin and Bren Simon Cancer Center /ID# 245133

    Indianapolis, Indiana, 46202-5112

  • Community Health Network, Inc. /ID# 245331

    Indianapolis, Indiana, 46250-2042

  • University of California, Los Angeles /ID# 243841

    Los Angeles, California, 90095

  • Yale School of Medicine /ID# 248418

    New Haven, Connecticut, 06519

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668

    New York, New York, 10065-6007

  • NEXT Oncology /ID# 231578

    San Antonio, Texas, 78229

  • Northwest Medical Specialties Tacoma /ID# 267339

    Tacoma, Washington, 98405

Other trials in United States

Spain13 sites

  • Hospital Universitario Fundacion Alcorcon /ID# 244505

    Alcorcón, Madrid, 28922

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 245379

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall de Hebron /ID# 249809

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 245374

    Barcelona, 08036

  • Hospital Universitario de Jaen /ID# 249201

    Jaén, 23007

  • Hospital General Universitario Gregorio Maranon /ID# 245270

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 231464

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 248417

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 244721

    Madrid, 28050

  • Clinica Universidad de Navarra - Pamplona /ID# 248816

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 245378

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 245213

    Seville, 41009

  • Hospital Universitario Miguel Servet /ID# 244456

    Zaragoza, 50009

Other trials in Spain

Japan10 sites

  • National Cancer Center Hospital /ID# 232007

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 232008

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of JFCR /ID# 248447

    Koto-ku, Tokyo, 135-8550

  • Kyoto University Hospital /ID# 250291

    Kyoto, Kyoto, 606-8507

  • Nagasaki University Hospital /ID# 250290

    Nagasaki, 852-8501

  • NHO Nagoya Medical Center /ID# 250286

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital /ID# 250284

    Nagoya, Aichi-ken, 464-8681

  • Niigata University Medical & Dental Hospital /ID# 250952

    Niigata, Niigata, 951-8520

  • Wakayama Medical University Hospital /ID# 250283

    Wakayama, Wakayama, 641-8510

  • Yokohama Municipal Citizen's Hospital /ID# 248842

    Yokohama, Kanagawa, 221-0855

Other trials in Japan

South Korea10 sites

  • Inje University Haeundae Hospital /ID# 244451

    Busan, Busan Gwang Yeogsi, 48108

  • Chungbuk National University Hospital /ID# 245168

    Cheongju-si, North Chungcheong, 28644

  • Gyeongsang National University Hospital /ID# 248420

    Jinju, Gyeongsangnam-do, 52727

  • CHA Bundang Medical Center /ID# 247115

    Seongnam, Gyeonggido, 13496

  • Seoul National University Hospital /ID# 244667

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 248401

    Seoul, Seoul Teugbyeolsi, 03181

  • Asan Medical Center /ID# 245215

    Seoul, Seoul Teugbyeolsi, 05505

  • SMG-SNU Boramae Medical Center /ID# 248421

    Seoul, Seoul Teugbyeolsi, 07061

  • Korea University Guro Hospital /ID# 244504

    Seoul, Seoul Teugbyeolsi, 08308

  • Yonsei University Health System Severance Hospital /ID# 245218

    Seoul, 03722

Other trials in South Korea

Taiwan10 sites

  • Changhua Christian Hospital /ID# 249150

    Changhua City, Changhua County, 50006

  • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 246449

    Kaohsiung City, Kaohsiung, 833

  • Cmuh /Id# 245729

    Taichung, 40701

  • National Cheng Kung University Hospital /ID# 245918

    Tainan, 704

  • Taipei Medical University Hospital /ID# 245732

    Taipei, 11031

  • Taipei Veterans General Hosp /ID# 250652

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917

    Taipei, 112

  • Tri-Service General Hospital /ID# 245733

    Taipei, 114

  • National Taiwan University Hospital /ID# 245731

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 248716

    Taoyuan City, 333

Other trials in Taiwan

France8 sites

  • Institut Bergonie /ID# 248028

    Bordeaux, Gironde, 33000

  • Centre Georges François Leclerc /ID# 244450

    Dijon, 21079

  • Centre Leon Berard /ID# 250987

    Lyon, Rhone, 69373

  • Centre Antoine-Lacassagne /ID# 231730

    Nice, Provence-Alpes-Côte d'Azur Region, 06189

  • AP-HP - Hopital Européen Georges Pompidou /ID# 250481

    Paris, 75015

  • CHU Nantes - Hopital Laennec /ID# 244723

    Saint-Herblain, Loire-Atlantique, 44800

  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399

    Saint-Herblain, Loire-Atlantique, 44805

  • Institut Gustave Roussy /ID# 246824

    Villejuif, Val-de-Marne, 94805

Other trials in France

Israel6 sites

  • Rambam Health Care Campus /ID# 231218

    Haifa, 3109601

  • Hadassah Medical Center /ID# 243821

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 244179

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center /ID# 243363

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 231217

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 245271

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Poland4 sites

  • Samodzielny Publiczny Zespó? Gru?licy i Chorób P?uc w Olsztynie /ID# 250466

    Olsztyn, 10-357

  • Med Polonia Sp. z o. o. /ID# 250799

    Poznan, Greater Poland Voivodeship, 60-693

  • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 251846

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 246569

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Australia2 sites

  • Austin Health /ID# 247667

    Heidelberg, Victoria, 3084

  • Mater Misericordiae Limited /ID# 249995

    South Brisbane, Queensland, 4101

Other trials in Australia

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC /ID# 231580

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide.

Read more

Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) [Part 2i] or mutated EGFR-expression (mutEGFR NSCLC) [Part 2ii], squamous NSCLC [Part 2iii], GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion [Part 4], participants MET amplification will receive IV ABBV-400 monotherapy in expansion [Part 5], participants MET mutation will receive IV ABBV-400 monotherapy in expansion [Part 6], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab [Part 7a], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets [Part 7b].

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Being tested
ABBV-400, Trifluridine/Tipiracil, Bevacizumab
Keywords
Non-Small Cell Lung Cancer, ABBV-400, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma, Colorectal Cancer, MET Amplification, MET Mutation, Trifluridine/Tipiracil, TAS-102, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

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

  • ABBV-400Drug

    Intravenous (IV) Infusion

  • Trifluridine/TipiracilDrug

    Also called TAS-102

    Oral Tablet

  • BevacizumabDrug

    IV Infusion

Study groups in NCT05029882
Study groupRoleWhat they receive
Part 1 (Monotherapy Dose Escalation)ExperimentalParticipants with advanced solid tumors will receive escalating doses of ABBV-400.
Receives: Drug: ABBV-400
Part 2i (wtEGFR Non-Small Cell Lung Cancer [NSCLC])ExperimentalParticipants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).
Receives: Drug: ABBV-400
Part 2ii (mutEGFR NSCLC)ExperimentalParticipants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D.
Receives: Drug: ABBV-400
Part 2iii (Squamous NSCLC)ExperimentalParticipants with squamous NSCLC will receive ABBV-400 at RP2D.
Receives: Drug: ABBV-400
Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel JunctExperimentalParticipants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D.
Receives: Drug: ABBV-400
Part 4 (Colorectal Cancer)ExperimentalParticipants with Colorectal Cancer (CRC) will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
Receives: Drug: ABBV-400
Part 5 (MET Amplification)ExperimentalParticipants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
Receives: Drug: ABBV-400
Part 6 (MET Mutation)ExperimentalParticipants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization.
Receives: Drug: ABBV-400
Part 7a (Combination Dose Escalation)ExperimentalParticipants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab.
Receives: Drug: ABBV-400; Drug: Bevacizumab
Part 7bi (Combination Dose Optimization Low Dose)ExperimentalParticipants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
Receives: Drug: ABBV-400; Drug: Bevacizumab
Part 7bii (Combination Dose Optimization High Dose)ExperimentalParticipants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
Receives: Drug: ABBV-400; Drug: Bevacizumab
Part 7biii (Combination Comparator)ExperimentalParticipants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab.
Receives: Drug: Trifluridine/Tipiracil; Drug: Bevacizumab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to 48 Months

Secondary outcomes (4)

  1. Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1

    DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to 48 Months

  2. PFS per RECIST v1.1

    Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.

    Measured: Up to 48 Months

  3. Overall survival (OS)

    Overall survival (OS) is defined as time from first study treatment to death due to any cause.

    Measured: Up to 48 Months

  4. Parts 1-6: ORR per Independent Central Review (ICR) in Participants with MET Amplification

    ORR defined as percentage of participants with confirmed best overall response of confirmed CR and PR per ICR according to RECIST version 1.1 in participants with MET amplification.

    Measured: Up to 48 Months

Timeline

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

  1. First posted1 Sep 2021
  2. Study start13 Oct 2021
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029882
Sponsor's protocol ID
M21-404
Other IDs
2023-509335-60-00, 2023
Status last verified
Oct 2025
First submitted
30 Aug 2021
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharma MR, Powderly J, Kuboki Y, Strickler JH, Perets R, Cohen JE, Raimbourg J, Nakajima TE, Yamamoto N, Cruz-Correa M, O'Neil B, Ghiringhelli F, Raghav K, Cecchini M, Bar J, Hunter Z, Burns M, Blaney M, Morrison-Thiele G, Aristide MN, Freise KJ, Li R, Li M, Vasilopoulos A, Biesdorf C, Sommerhalder D. Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors. J Clin Oncol. 2026 Jul 10;44(20):1876-1888. doi: 10.1200/JCO-25-01525. Epub 2026 May 1.

    PubMed 42066233

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-400, Trifluridine/Tipiracil and Bevacizumab in people with Non-Small Cell Lung Cancer and Advanced Solid Tumors, run by AbbVie at 82 sites in 10 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 31 inclusion and 4 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Spain, Japan, South Korea, Taiwan and 5 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 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.

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 Response Rate (ORR) (time frame: Up to 48 Months). 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 NCT05029882, which also lists 1 linked publication.

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 Oct 2025.

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