Patients With Advanced Solid TumorsPhase 1NCT05367232
A Study of ICP-033 in Patients With Advanced Solid Tumors
A Phase 1 study testing ICP-033 tablet in people with Patients With Advanced Solid Tumors, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- ICP-033 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to Dec 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
- At least one measurable lesion according to RECIST 1.1.
Who cannot join
- Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug.
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases.
- Patients who have active or history of interstitial lung disease or noninfectious pneumonia.
- Patients with QTc > 450 ms in males and > 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator.
- Patient with the Medication history and surgical history as stated in the protocol
- Those who are unsuitable for blood collection or contraindicated for blood collection.
- Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Sichuan, Chengdu, 610041
Feng Bi, +86 028-85423203, bifeng@medmail.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- ICP-033 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-033 tabletDrug
Administered orally, once a day, 28 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| ICP-033 Dose Escalation | Experimental | Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle. Receives: Drug: ICP-033 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Measured: through study completion, an average of 2 years
Dose-Limiting Toxicities (DLTs)
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Measured: through study completion, an average of 2 years
Maximum tolerated dose (MTD)
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Measured: through study completion, an average of 2 years
Recommended phase II dose (RP2D)
Measured: through study completion, an average of 2 years
Secondary outcomes (10)
The maximum plasma concentration observed (Cmax)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
Time of maximum observed plasma concentration (Tmax)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
Elimination half-life (t1/2)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
Apparent clearance (CL/F)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
Apparent volume of distribution (Vz/F)
To evaluate the pharmacokinetic (PK) characteristics of ICP-033 in patients with solid tumors.
Measured: through study completion, an average of 2 years
The objective response rate (ORR)
To evaluate the preliminary anti-tumor activity of ICP-033.
Measured: through study completion, an average of 2 years
Duration of response (DoR)
To evaluate the preliminary anti-tumor activity of ICP-033.
Measured: through study completion, an average of 2 years
Progression-free survival (PFS)
To evaluate the preliminary anti-tumor activity of ICP-033.
Measured: through study completion, an average of 2 years
Overall survival (OS)
To evaluate the preliminary anti-tumor activity of ICP-033.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start25 Feb 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Bi, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367232
- Sponsor's protocol ID
- ICP-CL-00701
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT05367232
- Acronym / sponsor ID
- ICP-CL-00701
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 May 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.
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-033 Dose Escalation | Experimental | Drug: ICP-033 tabletDrug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
- At least one measurable lesion according to RECIST 1.1.
Key exclusion criteria (7 listed)
- Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug.
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases.
- Patients who have active or history of interstitial lung disease or noninfectious pneumonia.
- Patients with QTc > 450 ms in males and > 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator.
- Patient with the Medication history and surgical history as stated in the protocol
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-033 tabletAdministered orally, once a day, 28 days per cycle | Drug | ICP-033 Dose Escalation |
Primary outcome
The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.
Time frame: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Dose-Limiting Toxicities (DLTs)
Time frame: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Maximum tolerated dose (MTD)
Time frame: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Recommended phase II dose (RP2D)
Time frame: through study completion, an average of 2 years
10 secondary outcomes
The maximum plasma concentration observed (Cmax)
Time frame: through study completion, an average of 2 years
Time of maximum observed plasma concentration (Tmax)
Time frame: through study completion, an average of 2 years
Elimination half-life (t1/2)
Time frame: through study completion, an average of 2 years
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)
Time frame: through study completion, an average of 2 years
Apparent clearance (CL/F)
Time frame: through study completion, an average of 2 years
Apparent volume of distribution (Vz/F)
Time frame: through study completion, an average of 2 years
The objective response rate (ORR)
Time frame: through study completion, an average of 2 years
Duration of response (DoR)
Time frame: through study completion, an average of 2 years
Progression-free survival (PFS)
Time frame: through study completion, an average of 2 years
Overall survival (OS)
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Feng Bi principal investigator
West China Hospital
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 ICP-033 tablet in people with Patients With Advanced Solid Tumors, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
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 3 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 7 Feb 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 China. 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 Feng Bi (+86 028-85423203, bifeng@medmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0. (time frame: through study completion, an average of 2 years). The study lists 4 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 7 Feb 2024.