Solid TumorPhase 1NCT06589401
Oral Paclitaxel for Patients with Advanced Solid Tumors
A Phase 1 study testing INP12 in people with Solid Tumor, run by InnoUp Farma S.L. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- INP12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
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- 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
- Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
- Patient with measurable or evaluable lesion.
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 90 days after the last dose of investigational product. Male partners of a female patient must use male condom plus spermicide throughout this period. * A woman is considered to be of childbearing potential from menarche to postmenopausal unless permanently sterilized. Sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menstruation for 12 months without an alternative medical cause. According to the CTFG recommendations, are considered highly effective contraceptive methods**: Combined hormonal treatment containing estrogen and progestogen (oral, intravaginal, transdermal); progestogen hormonal contraception associated with ovulation inhibition (oral, injectable, implantable); intrauterine device (IUD), hormone-releasing intrauterine system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence.
- Unsterilized and sexually active men who have a fertile female partner should use 2 effective and acceptable contraceptive methods from day 1 up to 90 days after receiving the last dose of INP12. Periodic abstinence, rhythm method, and interrupted intercourse are not acceptable contraceptive methods.
- Patients available for periodic blood tests and evaluations related to the study.
- Patients able and willing to comply with study procedures as per protocol.
Who cannot join
- 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.
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- 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.
- Unresolved AEs from a previous cancer treatment, defined according to the NCI CTCAE v5.0 classification (see Appendix 15.1) as unresolved events up to grade 0 or 1, or up to the levels required in the inclusion/exclusion criteria, with the exception of alopecia and laboratory values listed per the inclusion criteria Patients with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss).
- Pregnant or breastfeeding women.
- Patients with a known HIV infection, chronic or active hepatitis B or C or active hepatitis A.
- Patients with difficulty in swallowing or with any disorder in the gastrointestinal system that may affect the intake and/or absorption of the study drug.
- Major surgery (as defined by the Investigator) within 4 weeks prior to first dose of INP12 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.
- Severe or uncontrolled medical condition including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer, intense gastritis, or psychiatric disorder/social situations that limit compliance with the protocol.
- Any condition that, according to the Investigator, could potentially hamper compliance with the study protocol, the evaluation of INP12, the interpretation of the patient's safety, the study results, or the follow-up.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
VHIO
Barcelona, Catalonia
Irene Braña, PhD, MD
About this study
Official title: A Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of INP12 in Patients with Advanced Solid Tumors
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
- Being tested
- INP12
- Keywords
- Oral paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INP12Drug
Oral paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: INP12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2022
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoUp Farma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589401
- Sponsor's protocol ID
- INP12-01
- Status last verified
- Sep 2024
- First submitted
- 5 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of INP12 in Patients with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06589401
- Acronym / sponsor ID
- INP12-01
- Conditions
- Solid Tumor
- Keywords
- Oral paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- InnoUp Farma S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INP12 | Experimental | Drug: INP12In 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| INP12Oral paclitaxel | Drug | INP12 |
Primary outcome
• MTD determination
Time frame: 28 days
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.
• Incidence of INP12 Adverse Events (Safety and tolerability profile of INP12)
Time frame: 28 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Solid Tumors
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INP12 in people with Solid Tumor, run by InnoUp Farma S.L. at 1 site in Spain.
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 21 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maite Agüeros, PhD (+34639151974, magueros@innoupfarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• MTD determination (time frame: 28 days). The study lists 2 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 19 Sep 2024.