Locally Advanced Solid TumorPhase 1/2NCT07213817
A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours
A Phase 1/2 study testing IPN60300 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Ipsen at 12 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- IPN60300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 5 Dec 2025to 30 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Yale Cancer Center-Yale University
New Haven, Connecticut, 06510
- Recruiting
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
France3 sites, 3 recruiting
- Recruiting
Centre Leon Berard
Lyon
- Recruiting
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain
- Recruiting
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)
Villejuif
Spain3 sites, 2 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona
- Active, not recruiting
NEXT Quiron-Barcelona
Barcelona
- Recruiting
START Madrid CIOCC Hospital Universitario HM Sanchinarro
Madrid
About this study
Official title: 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 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.
Study Phases:
Read more
- Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose).
- Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance).
Study Periods:
Screening: Up to 28 days before first IPN60300 injection to determine eligibility.
Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor.
Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
- Being tested
- IPN60300
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPN60300Biological
IPN60300 will be administered at assigned dose level.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: Dose escalation | Experimental | IPN60300 will be administered at assigned dose level. Receives: Biological: IPN60300 |
| Phase Ib : Dose optimisation | Experimental | Participants will be randomised to one of the two doses of interest. Receives: Biological: IPN60300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Percentage of participants with dose limiting toxicity (DLT)
Measured: 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).
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.
Measured: From the first IPN60300 administration until 30 days after the last dose
Phase Ib: Objective response rate (ORR)
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
Measured: At end of study (up to approximately 3 years )
Secondary outcomes (14)
Phase Ia: Time to maximum observed drug concentration (tmax) of IPN60300 after single and multiple doses of IPN60300
Measured: within 21 days following study drug administration
Phase Ia: Maximum observed drug concentration (cmax) of IPN60300 after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration
Phase Ia: Area under the plasma concentration time curve over one dosing interval (AUCtau) of IPN60300 after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration
Phase Ia: Tmax of Total Antibody after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia: Cmax of Total Antibody after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia: AUCtau of Total Antibody after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia: Tmax of free toxin after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia: Cmax of free toxin after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia: AUCtau of free toxin after single and multiple doses of IPN60300
Measured: Within 21 days following study drug administration.
Phase Ia and Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (ADA), Including Binding and Neutralizing Antibodies.
Measured: Prior study drug administration until the End of Treatment (EoT) visit (approximately up to 3 years
Phase Ia: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
Measured: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
DoR is defined as the time from the first documented evidence of CR or PR until progressive disease, as determined by investigator per RECIST version 1.1, or death from any cause, whichever occurs first
Measured: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
PFS is defined as the time from the date of first IPN60300 administration to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1, or death due to any cause, whichever occurs first
Measured: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1
Measured: At end of study (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start5 Dec 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213817
- Sponsor's protocol ID
- CLIN-60300-450
- Other IDs
- 2025-522139-33-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07213817
- Acronym / sponsor ID
- CLIN-60300-450
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study Phases:
- Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose).
- Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance).
Study Periods:
Screening: Up to 28 days before first IPN60300 injection to determine eligibility.
Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor.
Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1a is sequential assignment - non-randomized, single arm. Part 1b is randomized, two-arm, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: Dose escalation | Experimental | Biological: IPN60300IPN60300 will be administered at assigned dose level. |
| Phase Ib : Dose optimisation | Experimental | Biological: IPN60300Participants will be randomised to one of the two doses of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPN60300IPN60300 will be administered at assigned dose level. | Biological | Phase Ia: Dose escalation, Phase Ib : Dose optimisation |
Primary outcome
Phase Ia: Percentage of participants with dose limiting toxicity (DLT)
Time frame: 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).
Time frame: 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)
Time frame: 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
14 secondary outcomes
Phase Ia: Time to maximum observed drug concentration (tmax) of IPN60300 after single and multiple doses of IPN60300
Time frame: within 21 days following study drug administration
Phase Ia: Maximum observed drug concentration (cmax) of IPN60300 after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration
Phase Ia: Area under the plasma concentration time curve over one dosing interval (AUCtau) of IPN60300 after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration
Phase Ia: Tmax of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Cmax of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: AUCtau of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Tmax of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Cmax of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: AUCtau of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia and Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (ADA), Including Binding and Neutralizing Antibodies.
Time frame: Prior study drug administration until the End of Treatment (EoT) visit (approximately up to 3 years
Phase Ia: Objective Response Rate (ORR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
Time frame: At end of study (up to approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipsen Medical Director study director
Ipsen
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPN60300 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Ipsen at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See e mail, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Percentage of participants with dose limiting toxicity (DLT) (time frame: within 21 days following study drug administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.