Assessing the safety and tolerability of ABSK-021 in patients with advanced solid tumors

A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

This study is testing a new oral medication called ABSK-021 to see if it's safe and tolerable for people with advanced solid tumors, especially those with tenosynovial giant cell tumor, who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abbisko Therapeutics Co, Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 17 sites (Beverly Hills, California and 16 other locations)
• Trial ID: NCT04192344 on ClinicalTrials.gov

What this trial studies

This open-label phase 1 study evaluates the safety, tolerability, and pharmacokinetics of oral ABSK-021 in patients with advanced solid tumors, particularly focusing on those with tenosynovial giant cell tumor (TGCT). The study consists of a dose escalation phase followed by an expansion phase, where the recommended dose will be administered in repeated 28-day cycles. Preliminary antitumor activity will also be assessed to gather initial efficacy data. Patients must have tumors that have progressed on standard therapies or for which no standard therapy exists.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed advanced solid tumors that have progressed on standard therapies or for whom no standard therapy exists.

Not a fit: Patients with early-stage tumors that can be treated with standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors, particularly those with TGCT, who have limited therapeutic alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but the specific use of ABSK-021 is novel.

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists
* ECOG (electrocorticogram) performance status 0\~1
* Life expectancy ≥ 3 months
* Adequate organ function and bone marrow function

For patients with tenosynovial giant cell tumor (TGCT) :

1. A diagnosis of TGCT \[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);
2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;
3. Others

Exclusion Criteria:

* Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors
* Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study 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, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)
* Major surgery within 4 weeks of the first dose of study drug and 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 ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo
* Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug
* Concomitant use of strong inhibitors or inducers of CYP3A4
* Active central nervous system (CNS) metastases
* Impaired cardiac function or clinically significant cardiac disease
* Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study
* Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection
* Refractory/uncontrolled ascites or pleural effusion
* Pregnant or nursing

For patients with tenosynovial giant cell tumor (TGCT) :

1. Known allergy or hypersensitivity to any component of the investigational drug product
2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）
3. Others

Where this trial is running

Beverly Hills, California and 16 other locations

• Precision NextGen Oncology — Beverly Hills, California, United States (Active_not_recruiting)
• SCRI at HealthOne — Denver, Colorado, United States (Completed)
• The Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (Completed)
• MD Anderson Cancer Center — Houston, Texas, United States (Completed)
• Beijing Jishuitan Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Sun Yat-sen University — Guangdong, Guangzhou, China (Recruiting)
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China (Completed)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Active_not_recruiting)
• The First Affiliated Hospital of Zhengzhou Universtity — Zhengzhou, Henan, China (Completed)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Active_not_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Active_not_recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Completed)
• Huashan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Completed)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Completed)
• Xi'an Hong Hui Hospital — Xian, Shanxi, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Siqing Fu, MD — M.D. Anderson Cancer Center
• Study coordinator: Yuan Lu

Conditions Neoplasms; Tenosynovial Giant Cell Tumor; TGCT; Solid tumors