Clinical trials: sponsored by Abbisko Therapeutics Co, Ltd
Solid Tumor
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX 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 ABSK121-NX administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and…
- Trial name
- NCT05627063
- Testing
- ABSK121-NX
- Where
- 24 sites in United States, China
- Volunteers
- 169 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Non-Small Cell Lung Cancer
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
- Trial name
- NCT06225804
- Testing
- ABSK112
- Where
- 14 sites in United States, China
- Volunteers
- 164 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Solid Tumor (Phase I)
A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
- Trial name
- NCT07718165
- Testing
- ABSK211
- Where
- China
- Volunteers
- 247 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Participants
A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants
This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011…
- Trial name
- NCT07700953
- Testing
- ABSK-011 Capsules, omeprazole enteric-coated tablets
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive
A Phase 2 Study of ABSK043 Combined With Osimertinib
This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer
- Trial name
- NCT07710612
- Testing
- ABSK043 in combination with Osimertinib
- Where
- 7 sites in China
- Volunteers
- 72 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its…
- Trial name
- NCT07007546
- Testing
- ABSK061
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Non-Small Cell Lung Cancer
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.
- Trial name
- NCT07164170
- Testing
- ABSK043 in combination with Glecirasib
- Where
- 17 sites in China
- Volunteers
- 86 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT).
- Conditions
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
- Trial name
- NCT05804045
- Testing
- Pimicotinib(ABSK021)
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 94 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Advanced Liver Cancer
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
This is an open-label phase 1 study with an escalation part and an expansion part.
- Trial name
- NCT04906434
- Testing
- ABSK-011
- Where
- 32 sites in United States, China and 1 more
- Volunteers
- 200 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Neoplasms, Tenosynovial Giant Cell Tumor
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021.
- Trial name
- NCT04192344
- Testing
- ABSK021
- Where
- 17 sites in United States, China
- Volunteers
- 276 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Solid Tumors, Adult
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.
- Trial name
- NCT07417189
- Testing
- ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE), ABSK141-800mg
- Where
- China
- Volunteers
- 401 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Hepatocellular Carcinoma
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients
This study is an open phase II clinical study, which consists of part a and Part B. Part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable HCC to And pk/pd…
- Trial name
- NCT05441475
- Testing
- ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w, ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg, ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg
- Where
- China
- Volunteers
- 118 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Hepatocellular Carcinoma (HCC)
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19…
- Trial name
- NCT07327034
- Testing
- ABSK-011+BSC
- Where
- 51 sites in China
- Volunteers
- 141 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Achondroplasia
A Study in Children With Achondroplasia
The goal of this observational study is to collect the anthropometric parameters, clinical characteristics, related medical complications, health-related quality of life and treatments of children with ACH, and complete a natural…
- Trial name
- NCT07301463
- Testing
- No Interventions, complete a natural history observation of ACH for at least 6 months and up to 2 years
- Where
- 8 sites in China
- Volunteers
- 260 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Achondroplasia
A Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia
This is a multicenter, non-randomized, open-label, phase I/II study in children with ACH. This study will start with a dose escalation of ABSK061 in children with ACH to evaluate the safety, tolerability, PK, and efficacy.
- Trial name
- NCT07297875
- Testing
- ABSK061
- Where
- 7 sites in China
- Volunteers
- 110 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Solid Tumors (Phase 1)
A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor…
- Trial name
- ABSK131-101 (NCT07288957)
- Testing
- ABSK131
- Where
- China
- Volunteers
- 266 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Healthy Subjects
A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules
The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose
- Trial name
- NCT06306872
- Testing
- Sequence A ABSK-011, Sequence B ABSK-011
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Pharmacokinetics in Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects
This is an open-label, randomized, two-treatment, single-dose, two-way crossover study to evaluate the relative bioavailability and tolerability of Pimicotinib capsules containing free base in different proportions in healthy…
- Trial name
- NCT07210996
- Testing
- pimicotinib capsules
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Pharmacokinetics
A Study to Evaluate the the Bioequivalence of Two Different Pimicotinib Capsules in Healthy Subjects
This is a study to evaluate bioequivalence and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition.
- Trial name
- NCT07126249
- Testing
- pimicotinib capsules
- Where
- China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- 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