A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors

NCT05244551 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ABSK061-101
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 22

Brief Summary

This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of DLT

  dose-limiting toxicities (DLTs)

  At the end of Cycle 1 (each cycle is 28 days)

• Incidence and severity of adverse events (AEs)

  adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)

  Through study completion, an average of half year

Secondary Outcomes (15)

• Cmax

  Through the study completion, an average of half year

• Tmax

  Through the study completion, an average of half year

• AUC

  Through the study completion, an average of half year

• t1/2

  Through the study completion, an average of half year

• Vz/F

  Through the study completion, an average of half year

Study Arms (1)

ABSK061

EXPERIMENTAL

Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed.

Drug: ABSK061

Interventions

ABSK061 DRUG

In the escalation part, patients will receive a single dose of oral ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in subsequent cycles (28-day cycles). The starting dose is 5 mg BID. In the expansion part, patients will each receive oral ABSK061 at the RDE in repeated 28-day cycles.

ABSK061

Eligibility Criteria

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

You may qualify if:

• Patient should understand, sign, and date the written informed consent form prior to screening.
• Male or female age 18 years or older.
• For escalation part: patients with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
• For expansion Part:
• Patients with histologically confirmed urothelial carcinoma or cholangiocarcinoma who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
• Patients must have tumors with following FGFR2/3 genetic alterations based on central laboratory test or existing test reports: Urothelial carcinoma: FGFR2/3 fusions and FGFR3 activating mutations Cholangiocarcinoma: FGFR2 fusions and/or arrangements
• Patients must have at least one measurable target lesion according to RECIST 1.1.
• Patients are willing to undergo biopsy if archival tumor tissue is not available or the archival specimen deemed inadequate or confirmed FGFR2/3 alterations from existing reports is not available.
• \. ECOG performance status 0 or 1 5. Life expectancy ≥3 months 6. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug:
• Absolute neutrophil count (ANC) ≥1.5×109/L
• Platelet count (PLT) ≥ 100×109/L without transfusion requirement within 14 days before 1st dose
• Hemoglobin (Hb)≥90 g/L
• Total bilirubin (TBIL) ≤1×ULN
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN.
• Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥ 50 mL/min based on Cockcroft-Gault formula

You may not qualify if:

• Known allergy or hypersensitivity to any component of the investigational product
• For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)
• Has a known additional malignancy that is progressing or has required active treatment.
• Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
• Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy or other investigational drugs received ≤4 weeks; endocrine therapy ≤2 weeks or ≤5-half life (whichever is shorter) prior to initiation of study treatment.
• Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence.
• Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE V5.0) with the exception of alopecia and vitiligo.
• Concomitant use of the drugs/remedies that may cause pharmacokinetic drug-drug interactions; consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice products within 7 days prior to the first dose of study medication.
• Active central nervous system (CNS) metastases including presence of cerebral edema, requirement for systemic steroid treatment, disease progression due to intracranial lesions, leptomeningeal metastasis, and other clinical symptoms related to CNS metastases.
• Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
• New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure
• Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF \>470 ms or history of long QT interval corrected (QTc) syndrome (Note: QTc interval corrected by Fridericia's formula).
• Left ventricular ejection fraction (LVEF) \<50% or below the institutional lower limit of normal (whichever is higher)
• Known human immunodeficiency virus (HIV) or active hepatitis B, or active hepatitis C infection; positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to hepatitis B core Ag (HBcAb), or hepatitis C RNA in serum (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test are allowed; positive tests for HBV HBsAg or HBcAb with HBV-DNA measurements lower than 1000IU/ml can be included)
• Any of the following ophthalmological criteria:

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (22)

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

Yuan LU

Shanghai, Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, 201203, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Chongqing Daping Hospital

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Gongshu District, China

RECRUITING

Sun Yat-sen Memorial Hospital/ the Second Affiliated Hospital of Sun Yat-sen University

Guanzhou, Guangdong, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

NOT YET RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

NOT YET RECRUITING

Xuzhou Center Hospital

Xuzhou, Jiangsu, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

JILIN Cancer Hospital

Changchun, Jilin, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Yunnan, Kunming, China

NOT YET RECRUITING

Liaoning Province Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Sichuan, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Yuan LU

CONTACT

+86 21 68910052; clinical@abbisko.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 17, 2022
• Study Start: June 30, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CN (21); US (1)