Advanced or Metastatic Solid TumorsPhase 1NCT06781983
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
A Phase 1 study testing IPH4502 in people with Advanced or Metastatic Solid Tumors, run by Innate Pharma at 7 sites in 2 countries.
Trial summary
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- IPH4502
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Jan 2025to Apr 2029
- 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
Main Inclusion Criteria:
- Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
- Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
- Measurable disease according to RECIST 1.1.
- Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.
- Adequate organ function and hematological function.
Main Exclusion Criteria:
- Known or suspected brain metastases.
- Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
- Participants with clinically significant comorbidity(s).
- History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
- Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.
- Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.
- Clinically significant cardiovascular disease and/or cardiac repolarization abnormality.
- Participants with symptomatic heart failure, Acute coronary syndromes
- Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.
- Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery.
- Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior to first dose of IPH4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of IPH4502; systemic use of moderate or strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Massachusetts General Hospital - Boston
Boston, Massachusetts, 02114
NEXT Oncology - Dallas
Dallas, Texas, 75039
NEXT Oncology - Virginia
Fairfax, Virginia, 22031
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Mount Sinai Tisch Cancer Center
New York, New York, 10029
France2 sites
Centre Léon Bérard
Lyon, 69008
Gustave Roussy Cancer Institute
Villejuif, 94805
About this study
Official title: A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
Read the detailed description
This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- IPH4502
- Keywords
- Exatecan, Topo-Isomerase I inhibitor, Squamous cell carcinoma of the head and neck, Esophageal squamous cell carcinoma, Triple negative breast cancer, Non-small cell lung cancer, Gastro-esophageal junction and gastric cancer, Colorectal carcinoma, Ovarian carcinoma, Prostate cancer, Cervical cancer, Melanoma, Urothelial carcinoma, Antibody-drug conjugates, ADC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH4502Drug
Part 1 (dose escalation) and Part 2 (dose optimization)
| Study group | Role | What they receive |
|---|---|---|
| IPH4502 Monotherapy | Experimental | Not described Receives: Drug: IPH4502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.
Measured: From time of first dose through treatment period, including the follow-up: up to 24 months
Secondary outcomes (6)
Maximum Observed Plasma Concentration (Cmax)
To characterize and evaluate the pharmacokinetic profile of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Area Under the Plasma Concentration (AUC)
To characterize and evaluate the pharmacokinetic profile of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Incidence of antidrug antibodies (ADA) against IPH4502
To evaluate the immunogenicity of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Objective Response Rate (ORR)
To investigate any preliminary antitumor activity of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Duration Of Response (DoR)
To investigate any preliminary antitumor activity of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Progression Free Survival (PFS)
To investigate any preliminary antitumor activity of IPH4502.
Measured: From time of informed consent through treatment period, including the follow-up: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start24 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781983
- Sponsor's protocol ID
- IPH4502-101
- Status last verified
- Nov 2026
- First submitted
- 8 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06781983
- Acronym / sponsor ID
- IPH4502-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- Exatecan, Topo-Isomerase I inhibitor, Squamous cell carcinoma of the head and neck, Esophageal squamous cell carcinoma, Triple negative breast cancer, Non-small cell lung cancer, Gastro-esophageal junction and gastric cancer, Colorectal carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
Detailed description
This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPH4502 Monotherapy | Experimental | Drug: IPH4502 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPH4502Part 1 (dose escalation) and Part 2 (dose optimization) | Drug | IPH4502 Monotherapy |
Primary outcome
Safety and Tolerability
Time frame: From time of first dose through treatment period, including the follow-up: up to 24 months
To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.
6 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Area Under the Plasma Concentration (AUC)
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Incidence of antidrug antibodies (ADA) against IPH4502
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Objective Response Rate (ORR)
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Duration Of Response (DoR)
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Progression Free Survival (PFS)
Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced or Metastatic Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPH4502 in people with Advanced or Metastatic Solid Tumors, run by Innate Pharma at 7 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?
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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, 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 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?
Safety and Tolerability (time frame: From time of first dose through treatment period, including the follow-up: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.