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An Open-label, Phase I/II First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522184-15-00
Acronym
CLIN-01203-450
Enrollment
38
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor, Metastatic Solid Tumor

Brief summary

Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT), 2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs), Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1

Detailed description

Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203, 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203, 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203, 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies, 5. Objective response rate (ORR), 6. Ph Ib Duration of response (DoR). DoR is defined as the time from 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, 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 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, for participants with SD as best response, with a minimum SD duration of 8 weeks, 8. Progression-free survival (PFS). PFS is defined as the time from the date of first IPN01203 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., 9. Disease control rate (DCR). DCR is defined as the percentage of participants with BOR of CR, PR, or SD, as determined by investigator per RECIST version 1.1, from the first IPN01203 administration throughout the study., 10. Time to response (TTR). TTR is defined as the time between date of start of treatment until first documented response (CR or PR), as determined by investigator per RECIST version 1.1., 11. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies

Interventions

Sponsors

Ipsen Pharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Ph Ia 1. Percentage of participants with dose limiting toxicity (DLT), 2. Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs), Ph Ib 3. objective response rate (ORR) Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or paritial response (PR), as determined by investigator per RECIST version 1.1

Secondary

MeasureTime frame
Ph Ia 1.Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01203, 2. Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01203, 3. Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01203, 4. Percentage of Treatment-Emergent Anti-Drug Antibodies (TEADA), Including Binding and Neutralizing Antibodies, 5. Objective response rate (ORR), 6. Ph Ib Duration of response (DoR). DoR is defined as the time from 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, 7. Duration of stable disease (SD). SD is defined as the time from the date of first IPN01203 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, for participants with SD as best response, wit

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026