A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

NCT05678270 | Recruiting Phase 2

• 1 other identifier: ICP-CL-00305
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 44

Brief Summary

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

Conditions

Intrahepatic Cholangiocarcinoma (ICC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Up to 3 years

Secondary Outcomes (12)

• Progression-free survival (PFS)

  Up to 3 years

• Disease control rate (DCR)

  Up to 3 years

• Duration of response (DOR)

  Up to 3 years

• Time to response (TTR)

  Up to 3 years

• Overall survival (OS)

  Up to 3 years

Other Outcomes (1)

• To explore the relationship between blood phosphorus and clinical efficacy

  Up to 3 years

Study Arms (1)

ICP-192

EXPERIMENTAL

Drug: ICP-192

Interventions

ICP-192 DRUG

ICP-192 is a round, uncoated tablet, 5mg, orally.

ICP-192

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 edition, TNM stage IV) tumor that has progressed following at least one line of chemotherapy and progression/recurrence within 6 months after neoadjuvant/adjuvant chemotherapy may be included.
• 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.

You may not qualify 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. 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 diastolic blood pressure ≥ 90 mmHg), and diabetes mellitus (HbA1c \> 8%).
• 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 node calcification, mild pulmonary parenchymal calcification, and asymptomatic coronary artery calcification.
• 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 and small bowel resection, etc.), or the patient was unable to swallow the drug orally.
• Active HBV infection, Active HCV infection, HIV infection.
• Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy within 6 months after the last dose of the study drug; or male subjects who plan to father a child during the study or within 6 months after the last dose of the study drug.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (44)

Anhui Provincial Hospital

Hefei, Anhui, 230036, China

NOT YET RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

NOT YET RECRUITING

Beijing Youan Hosptital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Fujian Cancer Hospital

Fujian, Fujian, 350011, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Mengchao hepatobiliary Hospital of FuJian Medical university

Fuzhou, Fujian, 350025, China

NOT YET RECRUITING

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050011, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

First Affiliated Hospital of Zhengzhou University.

Zhengzhou, Henan, 450066, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

NOT YET RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Human Provincial People's Hospital

Changsha, Hunan, 410002, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The Third Xiangya Hospital of Central South Uninversity

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Changzhou Tumor Hospital

Changzhou, Jiangsu, 213000, China

NOT YET RECRUITING

Jiangyin Renmin Hospital

Jiangyin, Jiangsu, 214499, China

NOT YET RECRUITING

The Affiliated Hospital of Nanjing University Meidical School

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

NOT YET RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

NOT YET RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

NOT YET RECRUITING

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, 110042, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Nanchang, 330029, China

NOT YET RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

NOT YET RECRUITING

Tangdu Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

NOT YET RECRUITING

Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250013, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

ZhongShan Hospital

Shanghai, Shanghai Municipality, 200123, China

NOT YET RECRUITING

The Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

NOT YET RECRUITING

Shulan（Hangzhou） Hospital

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jin Li

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li

CONTACT

021-38804518; lijin@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: November 15, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (44)