Advanced Solid TumorsPhase 1NCT05537987
Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
A Phase 1 study testing ICP-723 in people with Advanced Solid Tumors, run by InnoCare Pharma Inc. at 3 sites in United States.
Trial summary
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ICP-723
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jul 2021to Jul 2024
- 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
- Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
- Male or female patients with age ≥18 years old and ≤80 years old.
- Measurable lesion according to RECIST 1.1.
- Adequate organ functions that meet protocol requirement criteria.
- Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
- Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.
Who cannot join
- Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
- Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
- Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
- Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
- Has evidence of uncontrolled heart disease
- At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
- Other conditions considered by the investigator to be inappropriate for participation in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Kansas Medical / Cancer Centers
Kansas City, Kansas, 66506
NYU-Langone Medical Center
New York, New York, 10016
Northwest Medical Specialties
Tacoma, Washington, 98405
About this study
Official title: A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
- Conditions
- Advanced Solid Tumors
- Being tested
- ICP-723
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-723Drug
3+3 dose escalation
| Study group | Role | What they receive |
|---|---|---|
| ICP-723 | Experimental | Not described Receives: Drug: ICP-723 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
Measured: through study completion, an average of 1.5 years.
Secondary outcomes (8)
Objective response rate (ORR) determined using RECIST 1.1 criteria.
Measured: Through study completion, an average of 4 years
Disease control rate (DCR) determined using RECIST 1.1 criteria.
Measured: Through study completion, an average of 4 years
Peak concentration (Cmax)
Measured: Through study completion, an average of 4 years
Time to reach peak concentration (Tmax)
Measured: Through study completion, an average of 4 years
Half-life (t1/2)
Measured: Through study completion, an average of 4 years
Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t)
Measured: Through study completion, an average of 4 years
Apparent clearance (CL/F)
Measured: Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F),
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start30 Jul 2021
- Primary completionNov 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoCare Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Zhang, Principal investigator, University of Kansas Medical / Cancer Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537987
- Sponsor's protocol ID
- ICP-CL-00502
- Status last verified
- Jan 2023
- First submitted
- 8 Sep 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05537987
- Acronym / sponsor ID
- ICP-CL-00502
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- InnoCare Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Sep 2022 (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.
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-723 | Experimental | Drug: ICP-723 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
- Male or female patients with age ≥18 years old and ≤80 years old.
- Measurable lesion according to RECIST 1.1.
- Adequate organ functions that meet protocol requirement criteria.
- Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
Key exclusion criteria (7 listed)
- Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
- Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
- Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
- Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
- Has evidence of uncontrolled heart disease
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 |
|---|---|---|
| ICP-7233+3 dose escalation | Drug | ICP-723 |
Primary outcome
Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
Time frame: through study completion, an average of 1.5 years.
8 secondary outcomes
Objective response rate (ORR) determined using RECIST 1.1 criteria.
Time frame: Through study completion, an average of 4 years
Disease control rate (DCR) determined using RECIST 1.1 criteria.
Time frame: Through study completion, an average of 4 years
Peak concentration (Cmax)
Time frame: Through study completion, an average of 4 years
Time to reach peak concentration (Tmax)
Time frame: Through study completion, an average of 4 years
Half-life (t1/2)
Time frame: Through study completion, an average of 4 years
Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t)
Time frame: Through study completion, an average of 4 years
Apparent clearance (CL/F)
Time frame: Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F),
Time frame: Through study completion, an average of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
Jun Zhang principal investigator
University of Kansas Medical / Cancer Centers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICP-723 in people with Advanced Solid Tumors, run by InnoCare Pharma Inc. at 3 sites in United States.
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 6 inclusion and 7 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 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity (time frame: through study completion, an average of 1.5 years.). 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 20 Jan 2023.