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

NCT07213830 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLIN-01203-450
• Study Type: interventional
• Target: 102
• Locations: 4 countries
• Sites: 11

Brief Summary

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.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with dose limiting toxicity (DLT)

  Within 28 days of first dose

• Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE-SAEs).

  An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began

  From the first IPN01203 administration to 90 days after the last dose.

• Phase Ib: Objective Response Rate (ORR)

  Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1.

  At end of study (up to approximately 3 years)

Secondary Outcomes (11)

• Phase Ia: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203.

  Up to 28 days after study drug administration.

• Phase Ia: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203

  Up to 28 days after study drug administration.

• Phase Ia: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203.

  Up to 28 days after study drug administration.

• Phase Ia: Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies.

  From the first dose of study drug administration, at predefined intervals until the end of study (up to approximately 3 years)

• Phase Ia: Objective response rate (ORR)

  At end of study (up to approximately 3 years)

Study Arms (2)

Phase Ia: Dose Escalation

EXPERIMENTAL

Participants will receive assigned dose level IPN01203 administered intravenously (IV).

Biological: IPN01203

Phase Ib: Dose Optimisation

EXPERIMENTAL

Participants will randomly receive one of the two doses of interest, determined at the end of Phase Ia, of IPN01203 administered intravenously (IV).

Biological: IPN01203

Interventions

IPN01203 BIOLOGICAL

Study intervention will be provided in a vial.

Phase Ia: Dose Escalation; Phase Ib: Dose Optimisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 years of age, at the time of signing the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and/or MRI.
• All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.
• Have a life expectancy for disease-related mortality, as evaluated by the investigator.
• Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Adequate haematologic and end organ function
• Participant is capable of giving signed informed consent as described in the protocol.

You may not qualify if:

• Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.
• Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.
• History of known autoimmune disease
• History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.
• Left ventricular ejection fraction \<45%
• QT interval corrected by Fridericia (QTcF) \>470 ms (for women) and \>450 ms (for men) or CS arrhythmias.
• History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
• Prior organ transplantation.
• Chronic or ongoing active infections within 4 weeks prior to Cycle1 Day1 (C1D1).
• Presence of hepatitis B surface antigen (HBsAg) \[or hepatitis B core antibody (HBcAb)\] at screening or within 3 months prior to the first dose of study intervention.
• Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.
• Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:
• Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment.
• CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells/µL.
• Viral Load: Participants must have an undetectable viral load (HIV RNA \<50 copies/mL)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (11)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

START MidWest PI Sharma

Grand Rapids, Michigan, 49546, United States

RECRUITING

Sarah Cannon Research Institute PI McKean Nasville, TN, USA

Nashville, Tennessee, 37205, United States

RECRUITING

MD Anderson PI Champiat

Houston, Texas, 77030, United States

NOT YET RECRUITING

Start San Antonio PI Rasco

San Antonio, Texas, 78229, United States

RECRUITING

NEXT PI Spira

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Princess Margaret Cancer Center PI Spreafico

Toronto, Canada

RECRUITING

Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) - PI Ronan

Villejuif, France

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron PI Garralda Cabanas

Barcelona, Spain

NOT YET RECRUITING

NEXT Quiron-Barcelona - PI Saavedra Santa Gadea

Barcelona, Spain

RECRUITING

START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC) - Calvo Aller

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See email; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): July 14, 2032
• Study Completion (Estimated): July 14, 2032
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

ES (3); US (6); CA (1); FR (1)