A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ipsen
Study ID
NCT07213817
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

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

Interventions

  • IPN60300 — BIOLOGICAL
    IPN60300 will be administered at assigned dose level.

Study Details

This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.

Key Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2028

Study Design

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

Arms

  • Experimental: Phase Ia: Dose escalation
    IPN60300 will be administered at assigned dose level.
  • Experimental: Phase Ib : Dose optimisation
    Participants will be randomised to one of the two doses of interest.

Primary Outcome Measure

Phase Ia: Percentage of participants with dose limiting toxicity (DLT) [ Time Frame: within 21 days following study drug administration. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Yale Cancer Center-Yale UniversityNew HavenConnecticut06510-
START MidwestGrand RapidsMichigan49546-
Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
MD Anderson Cancer CenterHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center-Yale University· New Haven, CTSTART Midwest· Grand Rapids, MISidney Kimmel Cancer Center· Philadelphia, PAMD Anderson Cancer Center· Houston, TXNEXT Oncology· San Antonio, TXNEXT Oncology· Fairfax, VA

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