Patients With Advanced Solid TumorsPhase 1NCT05370755
A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
A Phase 1 study testing ICP-189 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-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody 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-189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 31 Jan 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 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
- Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
- Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
- Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
- Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (> grade 3 assessed by CTCAE 5.0).
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou
About this study
Official title: A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid Tumors.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- ICP-189
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-189Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: ICP-189 Dose Escalation | Experimental | Not described Receives: Drug: ICP-189 |
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-189 assessed by NCI-CTCAE V5.0
To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors.
Measured: through study completion, an average of 2 years
Dose-Limiting Toxicities (DLTs)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Measured: through study completion, an average of 2 years
Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD)
To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors
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-189 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-189 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-189 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-189 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-189 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-189 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-189.
Measured: through study completion, an average of 2 years
Duration of response (DoR)
To evaluate the preliminary anti-tumor activity of ICP-189.
Measured: through study completion, an average of 2 years
Progression-free survival (PFS)
To evaluate the preliminary anti-tumor activity of ICP-189.
Measured: through study completion, an average of 2 years
Overall survival (OS)
To evaluate the preliminary anti-tumor activity of ICP-189.
Measured: through study completion, an average of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start31 May 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Jan 2026 (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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370755
- Sponsor's protocol ID
- ICP-CL-00801
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05370755
- Acronym / sponsor ID
- ICP-CL-00801
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 11 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-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody 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 |
|---|---|---|
| Phase Ia: ICP-189 Dose Escalation | Experimental | Drug: ICP-189 |
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 (6 listed)
- Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
- Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
- Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
- Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (> grade 3 assessed by CTCAE 5.0).
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-189Administered orally | Drug | Phase Ia: ICP-189 Dose Escalation |
Primary outcome
The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
Time frame: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors.
Dose-Limiting Toxicities (DLTs)
Time frame: through study completion, an average of 2 years
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD)
Time frame: through study completion, an average of 2 years
To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors
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 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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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.
Caicun Zhou principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
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-189 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 6 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 11 May 2022. 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 Caicun Zhou (+86 13301825532, caicunzhoudr@163.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-189 assessed by NCI-CTCAE V5.0 (time frame: through study completion, an average of 2 years). The study lists 3 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 11 May 2022.