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IPH2201

Phase 3

Gynecologic Cancer | Monoclonal antibody | Oncology |Innate Pharma S.A.|Trials Updated: Aug 4, 2023

IPH2201 development status

Highest phase Phase 3 run by AstraZeneca (NCT04590963)
Phase scored for IPHAPhase 1
Registered trials 14 across 9 sponsors since Jan 2015

IPH2201 target and mechanism

ModalityMonoclonal antibody

Also known as Monalizumab, Anti-NKG2A

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment202

FDA Designations

No designations recorded

IPH2201 clinical trials

IPH2201 · 2 trials · 2 indications

Phase 1 2
NCT02459301A Dose-Ranging Study of IPH2201 in Patients With Gynecologic MalignanciesGynecologic Cancer
COMPLETED59 Analytics
NCT02643550Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck Neoplasms
COMPLETED143 Analytics
PHASE1COMPLETED
A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies
Gynecologic CancerUnlock trial analytics
PHASE1COMPLETED
Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Head and Neck NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose of single agent IPH2201 for phase II studies and determined based on toxicity, as well as pharmacokinetic and pharmacodynamics data
24 months

To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin.

Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study
within 4 weeks after first administration

To assess the occurrence of Drug Limited Toxicities (DLTs)

Objective Response Rate for expansion cohorts
up to 12 months

rate of patients in complete or partial response according to RECIST 1.1.

Secondary Endpoints

Number and severity of adverse events in patients
24 months
Correlative assays evaluation for potential predictive markers of IPH2201 effects. Concentration at the end of administration (Cinf end) for all patients
24 months
Area under the curve from time 0 to Tau=2 weeks (AUC(0-Tau)
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
IPH2201EXPERIMENTALPart 1: 1, 4 or 10mg/kg, IV, 1 hour duration on Day 1 every 2 weeks. Part 2: Patients will receive single agent IPH2201 as above with the actual dose dependent on the outcome of Part 1
Dose escalationEXPERIMENTALDose escalation of monalizumab in combination with cetuximab
Expansion cohort 1EXPERIMENTALmonalizumab + cetuximab expansion cohort
Expansion cohort 2EXPERIMENTALmonalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
Expansion cohort 3EXPERIMENTALmonalizumab + cetuximab + anti-PD(L)1

Interventions

NameTypeDescription
IPH2201DRUG -
MonalizumabBIOLOGICAL -
CetuximabBIOLOGICAL -
Anti-PD(L)1BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients must have a histologically and/or cytologically confirmed gynecologic malignancy including high-grade serous ovarian/fallopian tube or peritoneal carcinoma, cervical cancer (squamous cell carcinoma) or endometrial cancer (adenocarcinoma), that is advanced/metastatic/r...

Countries:CanadaUnited StatesFrance
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Frequently asked questions about IPH2201

What is IPH2201 used for?

IPH2201 is an investigational monoclonal antibody being studied in gynecologic cancer. It was evaluated in a Phase 1 dose-ranging study in patients with gynecologic malignancies. It is not approved for any indication and remains in clinical development.

Who is developing IPH2201?

IPH2201 is being developed by Innate Pharma S.A., which trades under the ticker IPHA. The company sponsored the Phase 1 dose-ranging study of IPH2201 in patients with gynecologic malignancies.

What phase is IPH2201 in?

IPH2201 is in Phase 1 clinical development. Its single trial, a dose-ranging study in gynecologic malignancies, has been completed. The drug is investigational and has not been approved for any indication.

What clinical trials is IPH2201 in?

IPH2201 has been studied in one clinical trial, NCT02459301, titled A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies. The Phase 1 trial enrolled 59 female patients aged 18 years and older in Canada and is completed.

Is IPH2201 FDA approved?

No. IPH2201 is an investigational monoclonal antibody in Phase 1 development and has not been approved for any indication. Its only clinical trial, a completed Phase 1 dose-ranging study in gynecologic malignancies, evaluated the drug in 59 patients.