A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Ipsen
Study ID
NCT06833008
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPN01195 — DRUG
    IPN01195 will be administered at assigned dose level.

Study Details

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.

Key Dates

Start date
Mar 14, 2025
Status verified
May 2026
Primary completion
Oct 3, 2028
Completion
Oct 3, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (dose escalation)
    IPN01195 will be administered at assigned dose level.
  • Experimental: Part B - (randomisation)
    Participants will be randomised to one of the two doses of interest once the PADR is determined

Primary Outcome Measure

Part A: Percentage of participants with dose limiting toxicity (DLT) [ Time Frame: Part A: within 28 days of first dose. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
START Mid-WestGrand RapidsMichigan49546-
Sarah Cannon Research Institute (SCRI) - NashvilleNashvilleTennessee37203-
Mary Crowley Cancer Research Centers - Medical City Hospital - DallasDallasTexas75230-
START Mountan RegionWest Valley CityUtah84119-
Virginia Cancer Specialist- FairfaxFairfaxVirginia22031-

Find similar trials in Grand Rapids, MI

By research site
START Mid-West· Grand Rapids, MISarah Cannon Research Institute (SCRI) - Nashville· Nashville, TNMary Crowley Cancer Research Centers - Medical City Hospital - Dallas· Dallas, TXSTART Mountan Region· West Valley City, UTVirginia Cancer Specialist- Fairfax· Fairfax, VA

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