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New pill targets Hard-to-Treat cancer mutation in early trial

NCT ID NCT05009329

Disease control Sponsor: Allist Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests an experimental oral drug called JAB-21822 (glecirasib) in people with advanced solid tumors that have a specific mutation in the KRAS gene (G12C). The trial aims to find the best dose and check if the drug is safe and can shrink tumors. About 315 adults whose cancer has not responded to standard treatments are participating.

What this could mean

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

Active substance
JAB-21822 (glecirasib), an oral drug that targets a specific cancer-driving mutation (KRAS G12C)
What this could lead to
If successful, this could provide a new treatment option for people with advanced cancers that have a KRAS G12C mutation, especially when other treatments have stopped working.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are possible and not yet fully known.

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

315 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2026

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. Written informed consent 2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment 3. Subject must be ≥18 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 5. Subjects with life expectancy ≥3 months. 6. Subjects must have at least one measurable lesion as defined by RECIST v1.1. 7. There was no serious organ dysfunction in the screening stage 8. Male or female subjects of reproductive age agree to use adequate contraception Exclusion Criteria: 1. History of intestinal disease or major gastric surgery or inability to swallow oral medications 2. Other active cancer 3. Previously treated with KRAS G12C inhibitor 4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) 5. Impaired heart function or clinically significant heart disease 6. Pregnant or breast-feeding 7. Previous allogeneic bone marrow transplant or organ transplant 8. Intended study subjects who were unable to abstain from alcohol during medication 9. Other unqualified conditions judged by the investigators

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

NSCLC Solid tumor

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.