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Advanced Solid TumorPhase 1/2NCT04145622

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

A Phase 1/2 study testing Ifinatamab deruxtecan (I-DXd) in people with Advanced Solid Tumor and Malignant Solid Tumor, run by Daiichi Sankyo at 23 sites in 2 countries.

Active, not recruiting

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

Official record
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Trial summary

This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Malignant Solid Tumor
What is being tested?
Ifinatamab deruxtecan (I-DXd)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
23 sitesin 2 countries
Study dates
3 Nov 2019to 31 Oct 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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator
  • Has adequate cardiac, hematopoietic, renal and hepatic functions
  • Has an adequate treatment washout period prior to start of study treatment
  • Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • For Expansion Cohort 4 2L ESCC participants only:
  • Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.

Who cannot join

  • Has prior treatment with B7-H3 targeted agent, including I-DXd.
  • Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
  • Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
  • Uncontrolled significant cardiovascular disease
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen
  • Has an uncontrolled infection requiring systemic therapy.
  • Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Japan13 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • Kagawa University Hospital

    Kagawa, 761-0793

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Showa Medical University Hospital

    Tokyo, 142-8666

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

United States10 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MDACC (MD Anderson Cancer Center)

    Houston, Texas, 77030

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)

This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.

The primary purpose of the parts are:

Read more
  • Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).
  • Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.

This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

  • they withdraw
  • their disease gets worse
  • they experience unacceptable side effects.
Being tested
Ifinatamab deruxtecan (I-DXd)
Keywords
Advanced Solid Tumor, Malignant Tumor, Ifinatamab deruxtecan (I-DXd)
Medical subject headings
Neoplasms

What participants receive

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

  • Ifinatamab deruxtecan (I-DXd)Drug

    A total anti-B7H3 antibody and MAAA-1181a

Study groups in NCT04145622
Study groupRoleWhat they receive
Dose escalationExperimentalParticipants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.
Receives: Drug: Ifinatamab deruxtecan (I-DXd)
Dose expansionExperimentalCurrently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion.
Receives: Drug: Ifinatamab deruxtecan (I-DXd)

What is being measured

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

  1. Evaluate the incidence of dose-limiting toxicities (DLTs)

    Measured: Day 1 to Day 21 in Cycle 1 in the dose escalation part

  2. Evaluate the incidence of adverse events (AEs)

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  3. Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Secondary outcomes (6)

  1. Characterize the PK parameter AUClast

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  2. Characterize the PK parameter AUCtau

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  3. Characterize the PK parameter Cmax

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  4. Characterize the PK parameter Tmax

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  5. Characterize the PK parameter Ctrough

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

  6. Assess the incidence of anti-drug antibodies (ADAs)

    Measured: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Timeline

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

  1. First posted30 Oct 2019
  2. Study start3 Nov 2019
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Oct 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
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145622
Sponsor's protocol ID
DS7300-A-J101
Other IDs
194992
Status last verified
Oct 2026
First submitted
17 Oct 2019
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Johnson ML, Patel MR, Falchook GS, Koyama T, Gutierrez M, Awad MM, Piha-Paul SA, Friedman CF, Satoh T, Okamoto N, Singh J, Yoshizuka N, Windish HP, Qian M, Tran BP, Doi T. Ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, in patients with advanced solid tumours (IDeate-PanTumor01): dose-escalation results from a phase 1/2 trial. Lancet Oncol. 2026 Apr;27(4):491-501. doi: 10.1016/S1470-2045(25)00733-8.

    PubMed 41926962

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ifinatamab deruxtecan (I-DXd) in people with Advanced Solid Tumor and Malignant Solid Tumor, run by Daiichi Sankyo at 23 sites in 2 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 7 inclusion and 7 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 6 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 23 sites in Japan, United States. 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?

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?

Evaluate the incidence of dose-limiting toxicities (DLTs) (time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part). The study lists 3 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 NCT04145622, 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 6 Oct 2026.

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