Solid TumorPhase 1NCT07836036
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
A Phase 1 study testing ASKC189 in people with Solid Tumor and RAS Mutation, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, RAS Mutation
- What is being tested?
- ASKC189
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 30 Sep 2026to 30 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old at the time of informed consent
- Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Have an estimated life expectancy ≥ 12 weeks
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory
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- Have consented to provide archival tumor tissue collected within 3 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Have adequate organ functions
- Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1
Who cannot join
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
- Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
- Prior treatment with a pan-RAS(ON) inhibitor
- Gastrointestinal conditions that may interfere with drug absorption
- Have a serious concomitant systemic disorder
- Have a serious pre-existing medical condition(s)
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- Prior or second concurrent primary malignancies
- Moderate or severe cardiovascular disease
- Have symptomatic central nervous system (CNS) malignancy or metastasis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University Cancer Hospital
Beijing
Lin Shen, MD
Shanghai East Hospital
Shanghai
Caicun Zhou, MD
About this study
Official title: A Phase I, Multi-center, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ASKC189 in Chinese Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Carrying RAS Gene Mutations.
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
- Conditions
- Solid Tumor, RAS Mutation
- Being tested
- ASKC189
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKC189Drug
ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
| Study group | Role | What they receive |
|---|---|---|
| ASKC189 oral capsule | Experimental | Not described Receives: Drug: ASKC189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 30 days following last dose
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to approximately 3 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836036
- Sponsor's protocol ID
- ASKC189-102
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ASKC189 in Chinese Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Carrying RAS Gene Mutations.
- ClinicalTrials.gov ID
- NCT07836036
- Acronym / sponsor ID
- ASKC189-102
- Conditions
- Solid Tumor, RAS Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASKC189 oral capsule | Experimental | Drug: ASKC189 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years old at the time of informed consent
- Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Have an estimated life expectancy ≥ 12 weeks
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
Key exclusion criteria (9 listed)
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
- Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
- Prior treatment with a pan-RAS(ON) inhibitor
- Gastrointestinal conditions that may interfere with drug absorption
- Have a serious concomitant systemic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKC189ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met. | Drug | ASKC189 oral capsule |
Primary outcome
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Time frame: Up to 21 days following first dose
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.
Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
Time frame: Up to 30 days following last dose
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.
10 secondary outcomes
Characterization of the PK profile of ASKC189
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 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
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
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of ASKC189
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Objective response rate (ORR)
Time frame: Up to approximately 3 years
Disease control rate (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASKC189 in people with Solid Tumor and RAS Mutation, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangsu Aosaikang Study Director (+86 025 52169999, ctr-contact@ask-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period (time frame: Up to 21 days following first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.