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Two-Drug cocktail targets Hard-to-Treat cancer mutation

NCT ID NCT05379946

Disease control Sponsor: InventisBio Co., Ltd Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests a combination of two oral drugs, D-1553 and IN10018, in people with advanced or metastatic solid tumors that have a specific genetic change called KRasG12C. The goal is to see if the combination is safe, tolerable, and effective at shrinking tumors. Participants must have tumors that have not responded to or are not eligible for standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of two oral drugs: D-1553, which targets the KRasG12C mutation, and IN10018
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors that have a KRasG12C mutation and have not responded to other therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the safety and effectiveness of the combination are not yet proven. It may not work for all tumor types or may cause unexpected side effects.

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 92 people

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

Started

Oct 2022

Expected to finish

Aug 2029

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: * Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment. * Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used. * Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC. * Subject has measurable disease according to RECIST, v1.1 Exclusion Criteria: Subject with unstable or progressive central nervous system (CNS) metastases. * Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above. * Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is \> 480 msec based on triplicate measurements of electrocardiogram (ECG). * Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment; * Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; * Subject is pregnant or lactating.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

Contacts and locations

Locations

  • Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,

    Hangzhou, Zhejiang, 310005, China

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