Clinical trial · Interventional
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
A Phase I, Open Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumour Activity of IPN60090 as Single Agent and in Combination in Patients With Advanced Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following an internal portfolio review, Ipsen has made the decision to terminate study D-US-60090-001. Ipsen would like to highlight that early termination was not due to any safety or tolerability issues with IPN60090
Summary
Brief summary (as posted)
The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPN60090 | Drug | — | UNRESOLVED |
| IPN60090 single administration | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- IPN60090
- description
- Part 1: Dose escalation of IPN60090, Part 2: Dose expansion IPN60090 given as a Bis in Die (BID) oral dose administered up to Maximum Tolerated Dose (MTD) over a 21-day cycle
- interventionNames
- Drug: IPN60090
- type
- EXPERIMENTAL
- label
- IPN60090 in combination with pembrolizumab
- description
- Part 1: Dose escalation of IPN60090 in combination with pembrolizumab, Part 2: Dose expansion IPN60090 given as a Bis in Die (BID) oral dose, starting with pharmacologically active dose identified in 1dose escalation of IPN60090 as a single agent, over a 21-day cycle in combination with 200 mg pembrolizumab given every 21 days (Day 1 of every cycle) as IV infusion
- interventionNames
- Drug: IPN60090
- Drug: pembrolizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients ≥18 years of age * Patients with solid tumours who have received at least one line of therapy for advanced disease * Measurable or non-measurable evaluable disease per RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1 * Standard of care and/or any investigational therapies must have been completed at least 3 weeks prior to treatment Exclusion Criteria: * Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder * Known primary central malignancy or symptomatic central nervous system metastasis * Major surgical intervention within 28 days before study drug administration * Significant acute or chronic infections
References
Publications (0)
Data not yet available