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IPH2201

Phase 1

Gynecologic Cancer | Small molecule | Oncology |Innate Pharma S.A.|Last Updated: Aug 4, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

IPH2201 · 1 trial · 1 indication

Phase 1 1
NCT02459301A Dose-Ranging Study of IPH2201 in Patients With Gynecologic MalignanciesGynecologic Cancer
COMPLETED59 Analytics
PHASE1COMPLETED
A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies
Gynecologic CancerUnlock 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.

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

Interventions

NameTypeDescription
IPH2201DRUG -
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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:Canada
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Frequently asked questions about IPH2201

What is IPH2201 used for?

IPH2201 is an investigational small molecule being studied for the treatment of gynecologic cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes IPH2201?

IPH2201 is being developed by Innate Pharma S.A., a biopharmaceutical company listed on the stock exchange under the ticker symbol IPHA.

What phase is IPH2201 in?

IPH2201 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is IPH2201 in?

IPH2201 has been studied in a completed Phase 1 trial with the identifier NCT02459301. This was a dose-ranging study in patients with gynecologic malignancies, conducted in Canada with 59 female participants aged 18 years and older.

Is IPH2201 a targeted therapy?

IPH2201 is being studied in a biomarker-selected patient population, indicating that its development involves the use of biomarkers to identify patients who may be more likely to respond to treatment.