Solid TumorPhase 1NCT03642834
Study of ICP-105 in Solid Tumors Patients
A Phase 1 study testing ICP-105 in people with Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study. 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?
- ICP-105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2018to 1 Mar 2021
- 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
- 18 Years and older.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- At least one evaluable disease according to RECIST1.1.
- Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
- Adequate bone marrow, liver, renal, and cardiovascular function.
Who cannot join
- Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.
- Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.
- Major surgery within 6 weeks of the first dose of ICP-105.
- Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.
- Crohn's disease with symptoms and systemic treatment.
- Central nervous system (CNS) metastasis.
Show all 13Show fewer
- Current clinically significant cardiovascular disease including:
- Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male).
- Known active bleeding within 2 months of screening or 6 months of bleeding history.
- Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism.
- Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection.
- Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
- Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-105 in Patients With Advanced Solid Malignancies
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.
Read the detailed description
The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).
- Conditions
- Solid Tumor
- Being tested
- ICP-105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-105Drug
25mg, 100mg capsule
| Study group | Role | What they receive |
|---|---|---|
| ICP-105 Single Arm | Experimental | ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose. Receives: Drug: ICP-105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
will be evaluated by CTCAE v4.03
Measured: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Secondary outcomes (3)
Cmax
the peak plasma concentration
Measured: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
AUC
area under the plasma concentration vs. time curve
Measured: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Apparent half-life for designated elimination phases (t½)
will be measured and calculated with noncompartmental analysis using WinNonlin
Measured: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Sep 2018
- Primary completion14 Dec 2020
- Study completion1 Mar 2021
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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, PhD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642834
- Sponsor's protocol ID
- ICP-CL-00201
- Status last verified
- Jun 2022
- First submitted
- 17 Aug 2018
- Last updated
- 6 Jul 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-105 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT03642834
- Acronym / sponsor ID
- ICP-CL-00201
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Aug 2018 (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.
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.
Detailed description
The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-105 Single Arm | Experimental | Drug: ICP-105ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 Years and older.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- At least one evaluable disease according to RECIST1.1.
- Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
- Adequate bone marrow, liver, renal, and cardiovascular function.
Key exclusion criteria (13 listed)
- Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.
- Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.
- Major surgery within 6 weeks of the first dose of ICP-105.
- Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.
- Crohn's disease with symptoms and systemic treatment.
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-10525mg, 100mg capsule | Drug | ICP-105 Single Arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
will be evaluated by CTCAE v4.03
3 secondary outcomes
Cmax
Time frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
AUC
Time frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Apparent half-life for designated elimination phases (t½)
Time frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Related trials for Solid Tumor
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
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.
Jin Li, PhD principal investigator
Shanghai East 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-105 in people with Solid Tumor, 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study). 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 6 Jul 2022.