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A Study of ICP-192 in Patients With Advanced Solid Tumors

PHASE1PHASE2RECRUITING

This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.

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Study details:

Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients); Part II (Phase II) of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations (30 patients).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits

Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available

Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy

Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration

Age ≥18 years old

At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1)

ECOG performance status of 0-1

Life expectancy for more than 3 months; Must have adequate organ function

Exclusion criteria

Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors

Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment

Patients with clinically significant gastrointestinal dysfunction

Has known central nervous system metastases

Has a history of or currently uncontrolled cardiovascular diseases

History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation

Current evidence of corneal or retinal abnormalities that may increase eye toxicity

Active hepatitis B virus active hepatitis C, or HIV infection

Has not recovered from reversible toxicity of prior anti-tumor therapy

Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration

Other conditions considered by the investigator to be inappropriate for participation in this study

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-02-01

Primary completion: 2023-11-30

Study completion finish: 2024-04-15

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT04565275

Intervention or treatment

DRUG: Drug ICP-192

Conditions

• Advanced Solid Tumors
• Urothelial Carcinoma
• Cholangiocarcinoma

Condition: Advanced Solid Tumors, Urothelial Carcinoma and more
DRUG: Drug ICP-192
Westmead, New South Wales, Australia and more
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Monash Medical Centre Clayton
Clayton, Victoria, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ICP-192 1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192	DRUG: Drug ICP-192 1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme 2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Phase I: Dose Escalation \& Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors	Up to 3 years
MTD	Phase I: Dose Escalation To determine Maximum Tolerated Dose（MTD) for ICP-192	Up to 3 years
OBD	Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192	Up to 3 years
RP2D	Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192	Up to 3 years
ORR	Phase II: Dose Expansion Objective Response Rate	Up to 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Peak concentration (Cmax)	Phase I: Dose Escalation Peak concentration (Cmax)	Up to 3 years
AUC	Phase I: Dose Escalation AUC	Up to 3 years
DCR	Phase II: Dose Expansion disease control rate	Up to 3 years
DOR	Phase II: Dose Expansion duration of response	Up to 3 years
PFS	Phase II: Dose Expansion progression-free survival	Up to 3 years
OS	Phase II: Dose Expansion overall survival	Up to 3 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study of ICP-192 in Patients With Advanced Solid Tumors