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A study to assess the safety, tolerability, pharmacokinetic, pharmacodynamic, immunogenicity and antitumour activity of IPN60300 in adults with locally advanced or metastatic solid tumours
EU CTIS ID: 2025-522139-33-00
What this study is testing
Phase Ia To evaluate the safety and tolerability of IPN60300 as a single agent and determine the MTD/MAD in participants with tumour type of interest Phase Ib To determine the optimal dosing regimen ofIPN60300 in participants with selected tumour(s)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (1) Participant must be ≥18 years of age, at the time of signing the informed consent.
- (10) 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
- (11) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- (12) Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator
- (2) Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumours 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.
- (3) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
You likely can't join if
- (1) Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention within the last 2 years prior to first dose of study intervention.
- (10) History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
- (11) Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
- (12) Any evidence of severe active infection or inflammatory condition
- (13) 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
- (14) Participants with uncontrolled human immunodeficiency virus (HIV). HIV-infected participants are eligible if they meet the criteria described in protocol
See the full eligibility criteria
Who can join
- (1) Participant must be ≥18 years of age, at the time of signing the informed consent.
- (10) 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
- (11) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
- (12) Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator
- (2) Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumours 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.
- (3) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- (5) 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.
- (6) Adequate bone marrow function within 7 days before first dose of study intervention
- (7) Adequate renal function within 7 days before first dose of study intervention
- (8) Adequate hepatic function or laboratory abnormalities indicating hepatic injury within 7 days before first dose of study intervention
- (9) Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN
What rules you out
- (1) Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention within the last 2 years prior to first dose of study intervention.
- (10) History of noninfectious interstitial lung disease (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
- (11) Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
- (12) Any evidence of severe active infection or inflammatory condition
- (13) 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
- (14) Participants with uncontrolled human immunodeficiency virus (HIV). HIV-infected participants are eligible if they meet the criteria described in protocol
- (15) Known active infection with hepatitis B virus (HBV) OR hepatitis C virus (HCV). Participants are eligible if they meet the criteria described in protocol
- (16) Prior anticancer therapy, including chemotherapy, targeted therapy, therapeutic anticancer antibodies, or radio-/toxin-immunoconjugates
- (17) Ongoing immunosuppressive therapy, including systemic corticosteroids.
- (2) 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.
- (3) History of major surgery within 4 weeks prior to the first dose of study intervention
- (4) Previous solid organ transplantation
- (5) Pre-existing, acute or chronic severe corneal disorders, sequelae from severe cornedisorders, or a history of corneal transplantation
- (6) Active brain metastases or leptomeningeal metastases with exception to asymptomatic and treated brain metastases
- (7) History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.
- (8) 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 NYHA Grade 2 or higher
- (9) History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.