Actively Recruiting
IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2026-02-27
92
Participants Needed
14
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
InxMed (Shanghai) Co., Ltd.
Lead Sponsor
R
Ranok Therapuetics Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open-label, Phase Ib/II clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.
CONDITIONS
Official Title
IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who fully understand the study and agree to participate by signing the consent form
- Male or female participants aged 18 years or older
- Diagnosed with locally advanced or metastatic solid tumors
- Confirmed positive for KRASG12D mutation in tumor tissue within 2 years
- For Phase Ib: tumors progressed or intolerant/failure to standard treatment
- For Phase II Cohort 1: locally advanced/metastatic PDAC previously treated with standard chemotherapy and failed treatment
- For Phase II Cohort 2: advanced solid tumors with progression and intolerant/failure to standard treatment
- At least one measurable lesion by CT or MRI according to RECIST 1.1
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, kidney, and coagulation function confirmed by lab tests within 7 days before first dose
- Females of childbearing potential agree to use effective contraception during study and for 6 months after last dose
- Male participants agree to abstain from sexual intercourse, undergo sterilization, or use effective contraception during study and for 6 months after last dose
You will not qualify if you...
- Prior treatment with KRASG12D inhibitors (except Phase Ib participants)
- Prior treatment with focal adhesion kinase (FAK) inhibitors
- Anti-cancer or investigational drug treatment or radiotherapy within 14 days before first dose
- Presence of other KRAS mutations besides KRASG12D or other mutations with available targeted drugs
- Known spinal cord compression or unstable/progressive CNS metastases; stable brain metastases allowed under conditions
- Serious cardiovascular diseases including heart failure NYHA class II or higher, severe arrhythmias, recent heart attack or surgery, low heart function, prolonged QT interval, uncontrolled hypertension, recent thrombosis or embolism
- Stroke or severe cerebrovascular disease within 12 months prior to treatment
- Interstitial lung disease or active infection requiring systemic treatment within 14 days prior to treatment
- Active autoimmune diseases requiring systemic treatment within past 2 years (exceptions allowed)
- History or evidence of substance abuse or conditions interfering with study participation
- Poorly controlled pleural, pericardial, or abdominal effusions; active bleeding during screening; recent live vaccines
- Gastrointestinal disorders impairing oral drug absorption or metabolism
- Unrecovered toxicity from previous anti-tumor treatment (except alopecia or pigmentation)
- Major surgery within 4 weeks prior to first dose or incomplete recovery from surgery
- Recent use or planned use of drugs affecting drug metabolism or causing heart rhythm issues
- Pregnant or breastfeeding women
- Positive for hepatitis B (with high viral load), hepatitis C, or HIV
- History of other cancers within 5 years except certain cured skin or in situ carcinomas
- Known allergy or severe intolerance to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
5
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He, China
Not Yet Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
7
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Not Yet Recruiting
8
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
9
The First Affiliated Hospital of China Medical University
Shengyang, Liaoning, China
Not Yet Recruiting
10
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
11
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
12
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Not Yet Recruiting
13
Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310005
Hangzhou, Zhejiang, China
Actively Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
S
Shangyu Chen, Bachelor
CONTACT
L
Lily LI, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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