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Tests treatment safety and results for Locally Advanced Solid Tumor
Official title A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
ClinicalTrials.gov ID: NCT07213817
What this study is testing
What is IPN60300?
IPN60300 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for locally advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Grand Rapids, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Lyon, France
- Saint-Herblain, France
- Villejuif, France
- Barcelona, Spain
- Madrid, Spain
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Grand Rapids, Michigan, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 5 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.