Oral Paclitaxel for Patients with Advanced Solid Tumors

NCT06589401 | Recruiting Phase 1

• 1 other identifier: INP12-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial evaluating the safety, tolerability, and pharmacokinetic profile of INP12, a nanoparticles-based oral paclitaxel, in patients with advanced solid tumors The aim in Part A (Escalation phase) is to determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD)and the recommended phase II dose (RP2D) of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors. The aim in Part B (Expansion phase) is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors.

Conditions

Solid Tumor

Keywords

Oral paclitaxel

Outcome Measures

Primary Outcomes (2)

• • MTD determination

  To determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD) and the recommended phase II dose (RP2D) of INP12 administered orally once weekly in patients with advanced solid tumors.

  28 days

• • Incidence of INP12 Adverse Events (Safety and tolerability profile of INP12)

  Tolerability will be defined by the number of patients experiencing any dose limiting toxicity (DLT) during the first 28-day cycle of INP12. Safety of INP12 will be assessed on the incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.03 (see Appendix 15.2). Other assessments will include safety laboratory parameters, vital signs, and electrocardiograms (ECG) in each dose group and in the expansion phase.

  28 days

Study Arms (1)

INP12

EXPERIMENTAL

In Part A (dose escalation), INP12 will be administered for 3 consecutive weeks (Days 1, 8, and 15) based on 28-day cycles. At least 3 patients will be included in each dose level. Each patient will be evaluated for dose-limiting toxicity (DLT) throughout the first cycle (28 days). In Part B (dose expansion), once the MTD is reached (or the highest protocol-defined dose in the absence of exceeding the MTD), an expanded cohort will be evaluated with the dose level of the MTD, or an intermediate one.

Drug: INP12

Interventions

INP12 DRUG

Oral paclitaxel

INP12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients; age ≥ 18 years at the time of study entry.
• Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Part A: Patients with a histologically and/or cytological confirmed solid tumor that is advanced and/or metastatic.
• Part B: Patients with a histologically and/or cytological confirmed solid tumor that is advanced and/or metastatic from which at least 50% should be patients with advanced or metastatic breast cancer.
• \*Note: If at the beginning of the phase-expansion there are patients still receiving INP12 in the phase-escalation, they will be offered to continue treatment with INP12 at the dose defined for the expansion phase.
• Patients for which standard therapy does not exist or is no longer effective.
• ECOG ≤ 2.
• Life expectancy of at least 12 weeks.
• No previous treatment with growth factors or blood transfusions within 28 days prior to the first dose of INP12.
• Patient with adequate organ and spinal function:
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Hemoglobin ≥ 9 g/dL
• Platelets (PTL) ≥ 100,000 mm3
• Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤ 2.5 x upper limit normal (ULN) (≤ 5 x ULN in case of hepatocellular carcinoma \[HHC\] or liver metastases)
• Total bilirubin ≤ 1.5 x ULN

You may not qualify if:

• Simultaneous enrollment in another clinical study unless it is an observational (non-interventional) study or the follow-up period of an interventional study.
• History of severe allergic reactions (ie, Grade 4 allergy, anaphylactic reaction from which the patient did not recover within 6 hours of institutional supportive care) to an unknown allergen or any components of the study drug formulations.
• Patients with dysphagia or disorders in gastrointestinal function.
• Previous hypersensitive reaction to taxanes.
• Previous hypersensitive reaction to corn.
• Concomitant systemic chemotherapy, hormonal therapy, and immunotherapy for the treatment of cancer.
• The concomitant use of hormones for non-oncological diseases is acceptable (eg, insulin for diabetes and hormone replacement therapy). Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
• Local treatment of isolated lesions with palliative intent is acceptable (eg, through surgery or local radiotherapy).
• Concomitant use of cytochrome P-450 (CYP) 3A4 inhibitors and/or inducers.
• Concomitant use of P-glycoprotein 1 (Pgp) inhibitors and/or inducers.
• Previous or current use of immunosuppressive drugs ≤ 28 days prior to the first dose of INP12, except intranasal, topical, and inhaled corticosteroids.
• Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of INP12.
• Primary central nervous system (CNS) tumor or untreated CNS metastatic disease, including leptomeningeal disease or spinal cord compression, except for previously treated patients who are asymptomatic and who have not required corticosteroids (at any dose) or anticonvulsants for at least 14 days before the selection.
• History of malignant tumors in the last 2 years, except for malignant non-invasive neoplasms, such as cervical carcinoma in situ, non-melanoma skin carcinoma, or ductal carcinoma in situ of the breast, cured by surgery.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• InnoUp Farma S.L.: lead

Study Sites (1)

VHIO

Barcelona, Catalonia, Spain

RECRUITING

Central Study Contacts

Maite Agüeros, PhD

CONTACT

+34639151974; magueros@innoupfarma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: September 19, 2024
• Study Start: September 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)