New drug combo targets Hard-to-Treat cancers with KRAS mutation
NCT ID NCT06166836
First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a combination of two oral drugs, D-1553 and IN10018, in people with advanced solid tumors that have a specific genetic change called KRAS G12C. The goal is to find the best dose and see if the combination can shrink tumors or slow their growth. About 140 adults whose cancer has worsened after standard treatments will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- D-1553 (a KRAS G12C inhibitor) and IN10018 (a focal adhesion kinase inhibitor)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced solid tumors that have a specific KRAS G12C mutation.
- What could go wrong
- This is an early-phase trial (1b/2) with a small number of participants. The combination may not work better than existing treatments, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men or women aged ≥ 18 years at the time of signing the informed consent form. 2. Subjects with pathologically confirmed locally advanced or metastatic solid tumors. 3. Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. 4. Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) Phase II Cohort A: subjects with locally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locally advanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locally advanced or metastatic solid tumors. 5. Has measurable lesions at baseline according to RECIST 1.1 criteria. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose. Exclusion Criteria: 1. Prior KRAS G12C inhibitors treatment. 2. Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis. 3. Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose. 4. Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose. 5. Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension. 6. Haven't recovered from toxicity due to prior antitumor therapy 7. Pregnant or lactating women. 8. Malignant neoplasms other than study disease within 5 years prior to enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Affiliated Hospital of Bengbu Medical College
Bengbu, China
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First Affiliated Hospital of Gannan Medical University
Ganzhou, China
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Fujian Cancer Hospital
Fuzhou, China
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General Hospital Of Eastern Theater Command
Nanjing, China
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Henan Cancer Hospital
Zhengzhou, China
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Hunan Cancer Hospital
Changsha, China
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Renmin Hospital of Wuhan University
Wuhan, China
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The first Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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Xuzhou Central Hospital
Xuzhou, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
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Other studies related to the condition(s) this trial covers.
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- New injectable drug tested for safety in Hard-to-Treat solid tumors
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
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- Mining Responders' tumors for clues to a universal cancer therapy
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