Safety and anti-tumor activity of IPN60300 in adults with advanced or metastatic solid tumors

An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.

This trial will test whether injections of IPN60300 are safe and can help control advanced or metastatic solid tumors in adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ipsen (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 12 sites (New Haven, Connecticut and 11 other locations)
• Trial ID: NCT07213817 on ClinicalTrials.gov

What this trial studies

This Phase 1/2, open-label trial gives adults with advanced or metastatic solid tumors injections of IPN60300 to determine safe dose ranges and observe anti-tumor effects. Phase Ia uses dose-escalation cohorts to identify a high and low dose based on safety, pharmacokinetics, pharmacodynamics, and immunogenicity, while Phase Ib randomizes patients with a specific tumor type to one of the two doses. Participants complete screening up to 28 days before the first dose and continue treatment until unacceptable toxicity, disease progression, or withdrawal. Key outcomes include safety and tolerability, PK/PD profiles, immune response, and preliminary antitumor activity measured by RECIST v1.1.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed locally advanced or metastatic solid tumors that are refractory to or lack standard therapy, with measurable disease by RECIST v1.1, ECOG 0–1, and adequate organ function are eligible.

Not a fit: Patients with poor performance status (ECOG ≥2), non-measurable disease, uncontrolled comorbidities or organ dysfunction, or contraindications to the investigational injection are unlikely to benefit from this early-phase trial.

Why it matters

Potential benefit: If successful, IPN60300 could provide a new systemic option that slows tumor growth or shrinks tumors in some patients with advanced solid cancers.

How similar studies have performed: Early-phase trials of novel targeted or immunomodulatory agents have produced meaningful responses in select tumor types, but IPN60300 itself is unproven and this approach remains experimental.

Eligibility criteria

Inclusion criteria:

* Participant must be ≥18 years of age, at the time of signing the informed consent.
* Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumors, that relapsed or were refractory after being previously treated with standard of care therapy; or for which there is no available established therapy; or standard therapy is contraindicated or not deemed appropriate by the treating investigator.
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* 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 bone marrow function within 7 days before first dose of study intervention,
* Adequate renal function within 7 days before first dose of study intervention,
* Adequate hepatic function or laboratory abnormalities indicating hepatic injury within 7 days before first dose of study intervention,
* Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN.
* At the time of screening, a tumour tissue specimen is required for enrolment into the dose escalation and dose optimisation portions of the study for retrospective central laboratory determination.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
* Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator.

Exclusion Criteria:

* Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention.
* Residual toxicity from prior anticancer therapy that are NCI CTCAE version 5.0 Grade 2 or higher. Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of investigator.
* History of major surgery within 4 weeks prior to the first dose of study intervention.
* Previous solid organ transplantation.
* Pre-existing, acute or chronic severe corneal disorders, sequelae from severe corneal disorders, or a history of corneal transplantation.
* Active brain metastases or leptomeningeal metastases with exception to asymptomatic and treated brain metastases (i.e. no neurological symptoms, no requirements for corticosteroids and lesions \<1.5 cm), which are stable and not expected to become symptomatic in the next 3 months in the opinion of the investigator.
* History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.
* History of clinically significant cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher.
* History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
* History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
* Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea \>Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
* Any evidence of severe active infection or inflammatory condition.
* Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures as per investigator assessment, including, but not limited to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
* Participants with uncontrolled human immunodeficiency virus (HIV). HIV infected participants are eligible if they meet criteria described in the protocol.
* Known active infection with hepatitis B virus (HBV) OR hepatitis C virus (HCV). Participants are eligible if they meet criteria described in the protocol.
* Ongoing immunosuppressive therapy, including systemic corticosteroids. NOTE: Physiologic replacement or use of topical or inhaled corticosteroids are allowed.
* Concurrent participation in another therapeutic treatment trial, previous participation should respect the minimum of 5 half-lives or 4 weeks before the study intervention initiation (whichever is shorter).
* Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.
* For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.

Where this trial is running

New Haven, Connecticut and 11 other locations

• Yale Cancer Center-Yale University — New Haven, Connecticut, United States (Recruiting)
• START Midwest — Grand Rapids, Michigan, United States (Recruiting)
• Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• NEXT Oncology — San Antonio, Texas, United States (Recruiting)
• NEXT Oncology — Fairfax, Virginia, United States (Recruiting)
• Centre Leon Berard — Lyon, France (Recruiting)
• Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau — Saint-Herblain, France (Not_yet_recruiting)
• Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) — Villejuif, France (Recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
• NEXT Quiron-Barcelona — Barcelona, Spain (Not_yet_recruiting)
• START Madrid CIOCC Hospital Universitario HM Sanchinarro — Madrid, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries

Conditions Locally Advanced Solid Tumor; Metastatic Solid Tumor