Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor; RAS Mutation
• Intervention / Treatment: Drug: ASKC189

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jiangsu Aosaikang Study Director; Phone Number: +86 025 52169999; Email: ctr-contact@ask-pharm.com

Study Locations

• China
  • Beijing, China
    • Peking University Cancer Hospital
    • Principal Investigator: Lin Shen, MD
  • Shanghai, China
    • Shanghai East Hospital
    • Principal Investigator: Caicun Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged ≥18 years old at the time of informed consent
2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Have an estimated life expectancy ≥ 12 weeks
5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
6. Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory
7. 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.
8. Have adequate organ functions
9. Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1

Exclusion Criteria:

1. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
2. Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
3. Prior treatment with a pan-RAS(ON) inhibitor
4. Gastrointestinal conditions that may interfere with drug absorption
5. Have a serious concomitant systemic disorder
6. Have a serious pre-existing medical condition(s)
7. Prior or second concurrent primary malignancies
8. Moderate or severe cardiovascular disease
9. Have symptomatic central nervous system (CNS) malignancy or metastasis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASKC189 oral capsule	Drug: ASKC189; ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 30 days following last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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	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)	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).	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).	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.	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.	Up to approximately 3 years
Overall survival (OS)	OS defined as the time from the first dose to death from any cause.	Up to approximately 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): September 23, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ASKC189-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No