RecruitingSolid Tumor
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Abbisko Therapeutics Co, Ltd
You may qualify if…
- ✓ 1. Patient should understand, sign, and date the written informed consent form prior to screening.
- ✓ 2. Male or female age 18 years or older.
- ✓ 3. 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:
- ✓ 1. 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.
- ✓ 2. 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
- ✓ 3. Patients must have at least one measurable target lesion according to RECIST 1.1.
- ✓ 4. 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.
You may not qualify if…
- ✕ 1. Known allergy or hypersensitivity to any component of the investigational product
- ✕ 2. For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)
- ✕ 3. Has a known additional malignancy that is progressing or has required active treatment.
- ✕ 4. 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
- ✕ 5. 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.
- ✕ 6. 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.
- ✕ 7. 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.
- ✕ 8. 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.
Where it's recruiting
Texas
Dallas
Source: ClinicalTrials.gov · NCT05244551 · last updated 2024-08-12