Dose Escalation Phase 1 Study of IOA-289 in combination with gemcitabine/nab-paclitaxel
- Registration Number
- 2024-515674-27-00
- Lead Sponsor
- iOnctura SA
- Brief Summary
The objective of study IOA-289-102 is to evaluate the safety and tolerability of escalating doses of IOA-289 in patients with metastatic pancreatic cancer in combination with standard chemotherapy consisting of gemcitabine and nab-paclitaxel. Blood and tumour samples for PK and PD will be collected and assessments for determination of any clinical efficacy will be completed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IOA-289 in combination with gemcitabine/nab-paclitaxel IOA-289 -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events [Safety and Tolerability] Adverse event assessment will be assessed by CTCAE v5.0, through study completion, an average of 1 year. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Cmax at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Peak plasma concentration
t½ at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Terminal elimination half-life
AUC0-∞ at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Area under the plasma concentration-time curve from time zero extrapolated to infinity
Preliminary efficacy Imaging for RECIST assessment will start at C2D1 ±3 Days and repeated every 8 Weeks (56 ± 5Days) until disease progression. Document preliminary signs of clinical efficacy of IOA-289 when given in combination with gemcitabine/nab-paclitaxel (e.g. overall response rate \[ORR\], duration of response \[DOR\], disease control rate (DCR), progression-free survival \[PFS\], and overall survival \[OS\] using RECIST v1.1)
Cmin at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Minimum observed plasma concentration
CA19-9 for an average of 6 months Assess changes of CA19-9 levels compared to baseline
Overall response rate [ORR] for an average of 6 months ORR defined as percentage of patients with a CR or PR based on appropriate radiographic imaging and consistent with RECIST 1.1
Disease control rate [DCR] for an average of 6 months DCR is defined as the combined percentage of patients with radiographic CR, PR and SD at different time points
tmax at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Time of the maximum observed plasma concentration
AUC0-t at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
BED for an average of 6 months Define the biologically effective dose (BED) of IOA-289 based on available parameters
Duration of response [DOR] for an average of 6 months DOR defined as time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve objective response
Progression free survival [PFS] for an average of 6 months PFS defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment
LPA for an average of 6 months Determine the PD activity of IOA-289, incl levels of LPA
Overall survival [OS] for an average of 6 months OS defined as the time from the date of the first dose of study treatment until death from any cause.
Trial Locations
- Locations (2)
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Azienda Ospedaliera Universitaria Integrata Verona🇮🇹Verona, ItalyDavide MelisiSite contact+390458128148davide.melisi@univr.it