A Phase 1 interventional study of ASKC189 in Solid Tumor and RAS Mutation, sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd. (part of Beijing Aosaikang Pharmaceutical Co., Ltd.) · Phase 1, Interventional, and Treatment
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ASKC189 in in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Jiangsu Aosaikang Pharmaceutical Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ASKC189
ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
DLT is short for Dose Limiting Toxicity, dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time frame: Up to 21 days following first dose
Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
AE refers to any untoward medical occurrence or deterioration of existing medical event after the investigational treatment, whether or not considered related to the study treatment.
Time frame: Up to 30 days following last dose
Characterization of the PK profile of ASKC189
AUC(inf) after single dose and AUC (0-τ) after single and multiple doses Maximum blood concentration (Cmax)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: blood concentration characteristics
Time to maximum blood concentration (Tmax)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: steady state characterization
Accumulation ratio (AR) at steady-state
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189: drug level characterization in blood
Apparent clearance (CL/F) after single and multiple doses
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189
ASKC189 apparent terminal half-life (t1/2)
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR (based on RECIST Version 1.1).
Time frame: Up to approximately 3 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame: Up to approximately 3 years
Duration of Response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to approximately 3 years
The identification of potential predictive biomarkers associated with response or resistance to ASKC189
Correlation of clinical outcomes with biomarkers to specific RAS mutation subtypes, and co-mutations in tumor tissue at baseline and progressive disease.
Time frame: Up to approximately 3 years
Start is estimated for Sep 2026; primary completion for Nov 2028, 26 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Aosaikang Pharmaceutical Co., Ltd. →