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New treatment option for Intrahepatic Cholangiocarcinoma (ICC)
Official title A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05678270
What this study is testing
What is ICP-192?
ICP-192 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intrahepatic cholangiocarcinoma (icc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG score of 0-1.
- Life expectancy \> 3 months.
- Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th...
- FGFR2 fusion /rearrangement as confirmed by the central laboratory.
You likely can't join if
- Presence of other malignancies requiring medical intervention.
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug...
- Known symptomatic central nervous system (CNS) metastases.
- Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0...
- Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.
See the full eligibility criteria
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG score of 0-1.
- Life expectancy \> 3 months.
- Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV) tumor that has progressed following at least one line...
- FGFR2 fusion /rearrangement as confirmed by the central laboratory.
- At least one measurable lesion at screening as target lesion per RECIST 1.1.
- Organ functions meeting the protocol requirements.
- Contraception according to the protocol requirements.
- Presence of other malignancies requiring medical intervention.
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Treatment with biological products, radical radiotherapy, and other investigational drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3 weeks prior to the first dose of study drug.
- Known symptomatic central nervous system (CNS) metastases.
- Patients who have not recovered from the toxicity caused by previous anti-tumor treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation criterion) at the first dose of study drug.
- Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.
- Any unstable or uncontrolled systemic disease as judged by the investigator, such as: active infection requiring intravenous therapy, uncontrolled hypertension (After treatment systolic blood pressure ≥ 150 mmHg and/or...
- Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.
- Wound with active infection.
- Major surgical procedures within 4 weeks prior to the first dose of the study drug or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity
- History and/or current evidence of extensive tissue calcification, including but not limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature and/or the lungs, with the exception of lymph...
- Clinically serious gastrointestinal dysfunction that may affect the intake, transport or absorption of the study drug (such as poorly controlled nausea, vomiting, diarrhea; malabsorption syndrome; intestinal obstruction...
- Active HBV infection, Active HCV infection, HIV infection.
- Female people who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male people who plan to father a child during the study or within 6 months after the...
- The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western medicine, traditional Chinese medicine) is less than 5 half-lives before the first dose of study drug, or plans to take concomitant drugs...
- Known allergy to any excipients of the study drug.
- people with conditions that in the investigator's opinion are not suitable for participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fujian, Fujian, China
- Fuzhou, Fujian, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Changzhou, Jiangsu, China
- Jiangyin, Jiangsu, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Nanchang, Nanchang, China
- Yinchuan, Ningxia, China
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fujian, Fujian, China; Fuzhou, Fujian, China; Foshan, Guangdong, China; Guangzhou, Guangdong, China and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.