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Study of IPN60300 for Advanced Solid Tumors

This study is testing a new drug called IPN60300 in adults with locally advanced or metastatic solid tumors (cancers that have spread from their original location). The main goals are to find a safe and effective dose of IPN60300 and to see how well it works against these cancers. All participants will receive IPN60300 by injection. The study is looking at side effects and how the body handles the drug, as well as how much the tumors shrink. You may be eligible if you are 18 or older and have advanced solid tumors that have not responded to standard treatments or for which there are no other established therapies. The current recruitment status is unclear.

Study design
This study involves two phases. In Phase Ia, participants with certain tumors will receive increasing doses of IPN60300 to find a safe range. In Phase Ib, participants with a specific tumor type will be randomly assigned to one of two doses identified in Phase Ia. The study plans to enroll 114 participants.
What's involved
You will undergo a screening period of up to 28 days to determine if you are eligible. The study will monitor for side effects from the first IPN60300 injection until 30 days after your last dose. Tumor response will be measured at the end of the study, which could be up to approximately 3 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for treatment-emergent adverse events and serious adverse events until 30 days after your last dose of IPN60300. Objective response rate will be measured at the end of the study, which could be up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213817

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ipsen
~114 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:IPN60300

At a glance

Recruiting sites
10 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ia: Percentage of participants with dose limiting toxicity (DLT)
Measured over within 21 days following study drug administration.
+2 more outcomes measured

Conditions

Locally Advanced Solid Tumor
Metastatic Solid Tumor

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Solid Neoplasm

NCT07213817

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centre Leon Berard

    Lyon, Franceno site contact published

    Recruiting

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

    Villejuif, Franceno site contact published

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainno site contact published

    Not yet recruiting

  • Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau

    Saint-Herblain, Franceno site contact published

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • NEXT Oncology

    San Antonio, Texasno site contact published

    Recruiting

  • NEXT Oncology

    Fairfax, Virginiano site contact published

    Recruiting

  • NEXT Quiron-Barcelona

    Barcelona, Spainno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
See e mail
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase Ia: Percentage of participants with dose limiting toxicity (DLT)within 21 days following study drug administration.
  • Phase Ia and Ib: Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TE SAEs).From the first IPN60300 administration until 30 days after the last dose

    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. A TEAE is an AE for which the start date is on or after the date that the intervention began or it was present prior to receiving the intervention but the intensity increased during the active phase of the study.

  • Phase Ib: Objective response rate (ORR)At end of study (up to approximately 3 years )

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as determined by investigator per RECIST version 1.1