Clinical trials: sponsored by Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects
This is a an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin .
- Trial name
- NCT06779253
- Testing
- pimicotinib capsules
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects
This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A…
- Trial name
- NCT06884072
- Testing
- Pimicotinib capsule
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Mass Balance Study of [14C]ABSK011
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK011 in healthy adult male subjects.
- Trial name
- NCT06896760
- Testing
- [14C]ABSK011
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021
Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021…
- Trial name
- NCT06322706
- Testing
- ABSK021, Omeprazole
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Pharmacokinetics
A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects
This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition.
- Trial name
- NCT06694948
- Testing
- pimicotinib capsules
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Pharmacokinetics
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control…
- Trial name
- NCT06562946
- Testing
- Pimicotinib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Non-Small Cell Lung Cancer With EGFR Mutation
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally…
- Trial name
- NCT06668103
- Testing
- ABSK043 in combination with Firmonertinib
- Where
- 5 sites in China
- Volunteers
- 54 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma
A Phase 2 Clinical Study of ABSK061 and ABSK043
The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
- Conditions
- HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors
- Trial name
- NCT06632262
- Testing
- ABSK061 + ABSK043, ABSK061+ABSK043 in combination with CAPOX
- Where
- 21 sites in China
- Volunteers
- 202 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Neoplasms
ABSK021 Food Effect Study in Healthy Subjects
This is a randomized, open-label, two-sequence, two-cycle, cross-over study to evaluate the relative bioavailability of ABSK021 after single-dose fasting and high-fat postprandial administration in healthy subjects
- Trial name
- NCT05280483
- Testing
- ABSK021 with fed state, ABSK021 with fasted state
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
cGvHD
A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)
This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.
- Trial name
- NCT06186804
- Testing
- ABSK021
- Where
- 14 sites in China
- Volunteers
- 64 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Mass Balance Study of [14C]ABSK021
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK021 in healthy adult male subjects.
- Trial name
- NCT06186583
- Testing
- Pimicotinib（ABSK021）
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021
This study is a single center, open lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of ABSK021 Oral administration.
- Trial name
- NCT06089733
- Testing
- Part A ABSK201 and Itraconazole, Part A ABSK201 and Rifampicin
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Solid Tumor
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
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…
- Trial name
- NCT05244551
- Testing
- ABSK061
- Where
- 22 sites in United States, China
- Volunteers
- 85 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Advanced Pancreatic Cancer
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer.
- Trial name
- NCT06111274
- Testing
- Pimicotinib (ABSK021)
- Where
- 5 sites in China
- Volunteers
- 82 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Urothelial Carcinoma
A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
This trial is an open, phase II clinical study. The study is divided into two parts: A and B, and the part A evaluate the safety and tolerability of AZD4547 combined with Tislelizumab in patients with locally advanced or…
- Trial name
- NCT05775874
- Testing
- AZD4547, Tislelizumab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Health, Subjective, Food-drug Interaction
ABSK091 Food Effect Study in Healthy Subjects
In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of a high-fat meal on the rate and extent of…
- Trial name
- NCT05533788
- Testing
- ABSK091 tablet
- Where
- Taiwan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Triple Negative Breast Cancer
A Study to Assess the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With TNBC
Objectives Phase 1b Primary Objectives: To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC Secondary Objectives: 1.
- Trial name
- NCT05103917
- Testing
- X4P-001
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Urothelial Carcinoma
A Phase 1b/2 Clinical Study to Evaluate the Safety and Tolerability and Efficacy of AZD4547
Phase 1b clinical study to evaluate the PK of oral AZD4547 in Chinese patients and RP2D. Phase 2 study to evaluate the efficacy of AZD4547 in urothelial carcinoma patients with FGFR2/3 gene alterations.
- Trial name
- NCT05086666
- Testing
- AZD4547
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Abbisko Therapeutics Co, Ltd