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New drug combo targets Hard-to-Treat cancers with KRAS mutation

NCT ID NCT06166836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • First Affiliated Hospital of Bengbu Medical College

    Bengbu, China

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, China

  • Fujian Cancer Hospital

    Fuzhou, China

  • General Hospital Of Eastern Theater Command

    Nanjing, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hunan Cancer Hospital

    Changsha, China

  • Renmin Hospital of Wuhan University

    Wuhan, China

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • Xuzhou Central Hospital

    Xuzhou, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005, China

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