A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Ipsen
Study ID
NCT07213830
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

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

Interventions

  • IPN01203 — BIOLOGICAL
    Study intervention will be provided in a vial.

Study Details

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours. Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body. There will be two parts to this study: * Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. * Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in "low dose" or "high dose." It will also further explore the safety and tolerability. An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib. Each part will consist of the following periods: * A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first. There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier. In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded. Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.

Key Dates

Start date
Feb 6, 2026
Status verified
May 2026
Primary completion
Jul 14, 2032
Completion
Jul 14, 2032

Study Design

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

Arms

  • Experimental: Phase Ia: Dose Escalation
    Participants will receive assigned dose level IPN01203 administered intravenously (IV).
  • Experimental: Phase Ib: Dose Optimisation
    Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV).

Primary Outcome Measure

Percentage of participants with dose limiting toxicity (DLT) [ Time Frame: Within 28 days of first dose ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
START MidWest PI SharmaGrand RapidsMichigan49546-
Sarah Cannon Research Institute PI McKean Nasville, TN, USANashvilleTennessee37205-
MD Anderson PI ChampiatHoustonTexas77030-
Start San Antonio PI RascoSan AntonioTexas78229-
NEXT PI SpiraFairfaxVirginia22031-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MASTART MidWest PI Sharma· Grand Rapids, MISarah Cannon Research Institute PI McKean Nasville, TN, USA· Nashville, TNMD Anderson PI Champiat· Houston, TXStart San Antonio PI Rasco· San Antonio, TXNEXT PI Spira· Fairfax, VA

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