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AzTrials

Breast Cancer MetastaticPhase 1/2ICARUSBREAST02NCT06298084

Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

A Phase 1/2 study testing Patritumab deruxtecan and Olaparib in people with Breast Cancer Metastatic and HER2-positive Metastatic Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC. The first 2 modules will evaluate: i. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patritumab deruxtecan and Olaparib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteFrance
Study dates
21 Mar 2024to Jun 2029
Phase
Phase 1/2
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

  • Patients must have received prior treatment with T-DXd and presented disease progression while on T-DXd treatment or within 2 months from T-DXd interruption/discontinuation for any reason, without requiring to be the last line of treatment. Patients who have received other lines of treatment after T-DXd and before study entry is capped at 10 patients for each cohort.
  • Patients with HER2-positive tumors must have received prior treatment with trastuzumab and taxanes. They may have received prior treatment with T-DM1 and pertuzumab.
  • Patients with HER2-low tumors must have been treated with taxanes. Patients with HR-positive tumors must have received ET and CDK4/6 inhibitors (patients may have received prior treatment with sacituzumab govitecan) If a patient has a tumor that was previously HER2-pos and became HER2-low, she/he will be included in cohort 2 and meet the inclusion criteria for HER2-low tumors.
  • If a patient has a tumor that was previously HR-pos and became HR-neg, prior therapy with CDK4/6 inhibitors is not mandatory.
  • Patients with germline pathogenic BRCA1/2 mutations and HER2-positive or HER2-low breast cancer are eligible to the study but must have received a prior treatment with PARP inhibitor (olaparib or talazoparib)
  • Female or male patient aged ≥18 years on the day of the ICF signature
Show all 22Show fewer
  • Patient who has histologically confirmed diagnosis of breast cancer with unresectable loco regional or metastatic disease
  • Patient must have an ECOG PS ≤1 at the time of screening
  • Patients must have HER2-pos (IHC 3+ or IHC2+/ISH positive) or HER-2 low (IHC2+/ISH negative or IHC 1+) tumors with any HR status, any time before T-DXd exposure
  • Patient must have at least one radiologically measurable lesion (different from the biopsy site) according to response evaluation criteria in solid tumors (RECIST) V1.1 criteria. At least one predominantly lytic or mixed lytic-blastic bone lesion with identifiable soft tissue component that can be evaluated by Computerized Tomography (CT)/Magnetic Resonance Imaging (MRI) must be present in patients with only bone metastasis
  • Patient must have a tumor site easily accessible to biopsy, avoiding bone biopsy when possible. Patients must have accepted to perform pre-treatment, on-treatment, and end-of-treatment biopsies
  • Patient must have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1, defined per the protocol
  • Female patients of reproductive/childbearing potential must have a negative pregnancy test at screening (serum test within 24 hours before C1D1 or urine test within 72 hours of C1D1) and must and must agree to use a highly effective form of contraception or avoid intercourse during and till the end of treatment and for at least 8 months after the last dose of study drug. The following contraception methods are considered highly effective:
  • Intrauterine device (IUD)
  • Bilateral tubal occlusion
  • Vasectomized partner
  • Complete sexual abstinence defined as refraining from heterosexual intercourse during and till the end of treatment and for at least 8 months for females after the last dose of study drug. Periodic abstinence not an acceptable method of contraception
  • Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 8 months after the final study drug administration
  • Male patients must be surgically sterile or must withhold heterosexual intercourse, or must be willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 5 months following the last dose of study drug
  • Male patients must not freeze or donate sperm starting at screening and throughout the study period, and for at least 5 months after the final study drug administration.
  • Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol
  • Patient must be affiliated to a social security system or beneficiary of the same

Who cannot join

  • The following exclusion criteria are applicable for all modules. Patients will be excluded if they present one of them:
  • Patient with a breast cancer amenable for resection or radiation therapy with curative intent
  • Patient with any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have ILD as assessed by imaging during screening
  • Patient with clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
  • Any underlying pulmonary disorder (eg, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion) OR
  • Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) OR
Show all 65Show fewer
  • Prior pneumonectomy
  • Patient receiving chronic systemic corticosteroids dosed at >10 mg/day prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study
  • Patient with evidence of any leptomeningeal disease
  • Patient with clinically significant corneal disease
  • Patient with any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility
  • Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1
  • Inadequate washout period prior to Cycle 1 Day 1, defined as:
  • Whole brain radiation therapy or stereotactic brain radiation therapy <14 days
  • Previous treatment with T-DXd < 28 days
  • Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study <14 days or 5 half-lives, whichever is longer
  • Endocrine therapy <21 days
  • Monoclonal antibodies <28 days including immune checkpoint inhibitors (ICIs)
  • Major surgery (excluding placement of vascular access) <28 days
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days
  • Live virus vaccination <28 days
  • Prior treatment with an anti-HER3 antibody
  • Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patients with chronic Grade 2 toxicities (defined as no worsening to Grade >2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the Investigator deems related to previous anticancer therapy, comprising the following, may be enrolled at the discretion of the Investigator:
  • Chemotherapy-induced neuropathy
  • Fatigue
  • Residual toxicities from prior immuno-oncology treatment: Grade 1 or Grade 2 endocrinopathies provided they are clinically stable and receiving hormone replacement therapy when applicable which may include:
  • Hypothyroidism/ hyperthyroidism
  • Type I diabetes
  • Hyperglycemia
  • Adrenal insufficient
  • Adrenalitis
  • Skin hypopigmentation (vitiligo)
  • Has known hypersensitivity to either the drug substances or the inactive ingredients of HER3-DXd and/or T-DXd
  • Patient with a history of severe hypersensitivity reactions to other monoclonal antibodies or PARP inhibitors
  • Has any malignancy other than locally advanced or ABC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer or curatively treated in-situ disease or other curatively treated solid tumors
  • Documented uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1, including:
  • Corrected QT interval >450 ms according to Fridericia's formula (QTcF) based on triplicate 12-lead ECGs, approximately 1 minute apart
  • LVEF <45% by either ECHO or MUGA or cardiac MRI if clinically indicated according to the investigator or consulting cardiologist
  • Resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg
  • Myocardial infarction within 6 months
  • Symptomatic congestive heart failure (NYHA class from III to IV)
  • Uncontrolled angina pectoris within 6 months
  • Cardiac arrhythmia not controlled by ongoing antiarrhythmic treatment
  • Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome
  • History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
  • Patient has bradycardia of less than 50 bpm (as determined by central reading) unless the subject has a pacemaker
  • History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers
  • Coronary/peripheral artery bypass graft within 6 months
  • Complete left bundle branch block
  • Active Hepatitis B and/or Hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of Cycle 1, Day 1. Patients with past or resolved Hepatitis B virus (HBV) infection are eligible if:
  • Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive; OR
  • HBsAg positive and HBV deoxyribonucleic acid (DNA) viral load is documented to be ≤ 2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases (in the absence of liver metastasis); OR
  • HBsAg positive and HBV DNA viral load is documented to be ≤2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with liver metastasis and abnormal transaminases AST/ALT <3 ULN For patients with HBsAg positive, if abnormal liver function is detected during study drug treatment, viral load should be tested to rule out reactivation.
  • Patients with a history of Hepatitis C infection will be eligible for enrollment only if the viral load according to local standards of detection, is documented to be below the level of detection in the absence of anti-viral therapy during the previous 12 weeks (ie, sustained viral response according to the local product label but not less than 12 weeks, whichever is longer)
  • Female patient who is pregnant or breastfeeding or intends to become pregnant during the study
  • Has a known human immunodeficiency virus (HIV) infection that is not well controlled. All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of >350 cells/μL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the patient's viral RNA load and CD4+ cell count should be monitored per local standard of care (eg, every 3 months). Patients with a well-controlled HIV infection may only be enrolled into Part 2 (dose expansion) of the study.
  • Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results
  • Adult under legal protection: guardianship, curatorship, or legal protection; or patient deprived of his/her liberty by a judicial or administrative decision; or patient incapable of giving his/her consent, or patient under psychiatric care
  • Participation in another clinical trial evaluating an experimental drug during the last 4 weeks (except non-interventional research) Specific exclusion criteria for each module
  • Module 0:
  • There are no specific exclusion criteria for module 0 (HER3-DXd monotherapy). Module 1 (olaparib)
  • History of hypersensitivity to excipients of olaparib
  • Inadequate washout period prior to Cycle 1 Day 1, defined as:
  • Strong CYP3A inhibitors < 1 week
  • CYP3A inducers for olaparib and phenobarbital < 5 weeks and for any other drug < 3 weeks

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Barbara Pistilli contact

+33 (0)1 42 11 61 62

barbara.pistilli@gustaveroussy.fr

Fernanda Mosele contact

+33 (0)1 42 11 61 43

Mariafernanda.MOSELE@gustaveroussy.fr

France1 site, 1 recruiting

  • Gustave Roussy Institut

    Villejuif, France, 94805

    Barbara Pistilli, +33 (0)1 42 11 61 62, barbara.pistilli@gustaveroussy.fr

    Fernanda Mosele, +33 (0)1 42 11 61 43, Mariafernanda.MOSELE@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: Phase 1b/2, Multicenter, Open-label, Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.

The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).

Read more

The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.

The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.

Being tested
Patritumab deruxtecan, Olaparib

What participants receive

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

  • Patritumab deruxtecanDrug

    Also called U3-1402, HER3-DXd

    5.6 mg/kg every 21 days

  • OlaparibDrug

    Also called Lynparza

    100 mg b.i.d PO days 8-14 every 21 days

Study groups in NCT06298084
Study groupRoleWhat they receive
Part 1a (safety run-in module 0)ExperimentalPatients with HER2-low ABC who have progressed on T-DXd. Patients in part 1a will receive intravenous infusion of HER3-DXd monotherapy (5.6 mg/kg every 21 days)
Receives: Drug: Patritumab deruxtecan
Part 1b (dose finding module 1 + dose expansion module 0)ExperimentalIn the dose expansion part, patients will receive the RP2D defined in the dose finding part of different combinations (module 1) and HER3-DXd single agent 5.6 mg/kg IV D1 every 21 days in module 0.
Receives: Drug: Patritumab deruxtecan; Drug: Olaparib
Part 2 (dose expansion module 1 + module 0)ExperimentalIn the dose expansion part, patients will receive the RP2D defined in the dose finding part of different combinations (module 1) and HER3-DXd single agent 5.6 mg/kg IV D1 every 21 days in module 0.
Receives: Drug: Patritumab deruxtecan; Drug: Olaparib

What is being measured

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

  1. DLTs (dose-limiting toxicity) for part 1a and 1b

    DLTs

    Measured: 21 months after the beginning of enrolment

  2. Frequency of safety event for part 1a and 1b

    frequency of any AEs, TEAEs, SAEs, AESIs graded by NCI-CTCAE v5.0

    Measured: 21 months after the beginning of enrolment

  3. Severity of safety event for part 1a and 1b

    severity of any AEs, TEAEs, SAEs, AESIs graded by NCI-CTCAE v5.0

    Measured: 21 months after the beginning of enrolment

  4. Proportion of treatment modification due to AEs for part 1a and 1b

    Proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs

    Measured: 21 months after the beginning of enrolment

  5. frequency of laboratory abnormalities for part 1a and 1b

    frequency of laboratory abnormalities defined by NCI-CTCAE v5.0 laboratory findings

    Measured: 21 months after the beginning of enrolment

  6. Severity of laboratory abnormalities for part 1a and 1b

    Severity of laboratory abnormalities defined by NCI-CTCAE v5.0 laboratory findings

    Measured: 21 months after the beginning of enrolment

  7. radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b

    Evaluations must include CT (preferably high-resolution CT) and pulmonologist consultation (when the Investigator is not a pulmonologist). Those will be reviewed by an internal multidisciplinary team at GRCC.

    Measured: 21 months after the beginning of enrolment

  8. ORR for part 2

    ORR is defined as the proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators after 6 months of treatment initiation. The objective response will be radiologically assessed every 6 weeks during the first year than every 12 weeks thereafter using RECIST v1.1.

    Measured: 51 months

  9. DOR for part 2

    DOR is defined as the time from the date of the first documentation of confirmed response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause, whichever occurs first. Duration of response will be measured for responding patients (CR or PR) only

    Measured: 51 months

  10. PFS for part 2

    PFS is defined as the time from date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, PFS will be censored at the date of last adequate radiological assessment without progression

    Measured: 51 months

  11. CBR for part 2

    CBR is defined as the presence of at least a confirmed PR or CR, or a stable disease (SD) ≥ 6 months

    Measured: 51 months

Secondary outcomes (15)

  1. ORR for part 1

    ORR is defined as the proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators after 6 months of treatment initiation. The objective response will be radiologically assessed every 6 weeks during the first year than every 12 weeks thereafter using RECIST v1.1.

    Measured: 45 months

  2. DOR for part 1

    DOR is defined as the time from the date of the first documentation of confirmed response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause, whichever occurs first.Duration of response will be measured for responding patients (CR or PR) only

    Measured: 45 months

  3. PFS for part 1

    PFS is defined as the time from date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, PFS will be censored at the date of last adequate radiological assessment without progression.

    Measured: 45 months

  4. CBR for part 1

    CBR is defined as the presence of at least a confirmed PR or CR, or a stable disease (SD) ≥6 months

    Measured: 45 months

  5. PK analysis for part 1

    Serum concentration of HER3-DXd (Anti-HER3-ac-DXd total, anti-HER3 antibody and DXd), plasma concentration of olaparib, will be assessed for PK analysis. Estimation of the proportion of deconjugated payload-linker complex binding with circulating albumin will also be assessed.

    Measured: 45 months

  6. ADA analysis for part 1

    Serum concentration of HER3-DXd (Anti-HER3-ac-DXd total, anti-HER3 antibody and DXd), plasma concentration of olaparib, will be assessed for incidence and prevalence of anti-drug antibody (ADA) for HER3-DXd. Estimation of the proportion of deconjugated payload-linker complex binding with circulating albumin will also be assessed.

    Measured: 45 months

  7. DLTs for part 2

    Measured: 39 months from the beginning of enrolment

  8. Frequency of safety event for part 2

    Frequency of any AEs, TEAEs, SAEs, AESIs graded by NCI-CTCAE v5.0;

    Measured: 39 months from the beginning of enrolment

  9. Severity of safety event for part 2

    Frequency of any AEs, TEAEs, SAEs, AESIs graded by NCI-CTCAE v5.0;

    Measured: 39 months from the beginning of enrolment

  10. proportion of treatment modification event for part 2

    proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs

    Measured: 39 months from the beginning of enrolment

  11. frequency of laboratory abnormalities for part 2

    frequency of laboratory abnormalities defined by NCI-CTCAE v5.0;

    Measured: 39 months from the beginning of enrolment

  12. Severity of laboratory abnormalities for part 2

    Severity of laboratory abnormalities defined by NCI-CTCAE v5.0;

    Measured: 39 months from the beginning of enrolment

  13. radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2

    Evaluations must include CT (preferably high-resolution CT) and pulmonologist consultation (when the Investigator is not a pulmonologist). Those will be reviewed by an internal multidisciplinary team at GRCC.

    Measured: 39 months from the beginning of enrolment

  14. PK analysis for part 2

    Serum concentration of HER3-DXd (Anti-HER3-ac-DXd total, anti-HER3 antibody and DXd), plasma concentration of olaparib, will be assessed for PK analysis. Estimation of the proportion of deconjugated payload-linker complex binding with circulating albumin will also be assessed.

    Measured: 39 months from the beginning of enrolment

  15. ADA analysis for part 2

    Serum concentration of HER3-DXd (Anti-HER3-ac-DXd total, anti-HER3 antibody and DXd), plasma concentration of olaparib, will be assessed incidence and prevalence of anti-drug antibody (ADA) for HER3-DXd. Estimation of the proportion of deconjugated payload-linker complex binding with circulating albumin will also be assessed.

    Measured: 39 months from the beginning of enrolment

Timeline

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

  1. First posted7 Mar 2024
  2. Study start21 Mar 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionJun 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06298084
Sponsor's protocol ID
2023-505925-15-00
Other IDs
2023/3668, 2023
Acronym
ICARUSBREAST02
Status last verified
Aug 2026
First submitted
12 Feb 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Patritumab deruxtecan and Olaparib in people with Breast Cancer Metastatic and HER2-positive Metastatic Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 22 inclusion and 65 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

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?

Contact Barbara Pistilli (+33 (0)1 42 11 61 62, barbara.pistilli@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (dose-limiting toxicity) for part 1a and 1b (time frame: 21 months after the beginning of enrolment). The study lists 11 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 NCT06298084.

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 4 Sep 2026.

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