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New pill targets common cancer mutation in early trial

NCT ID NCT06585488

Disease control Sponsor: BeOne Medicines 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 3 times

Summary

This early-phase study tested a new drug called BGB-53038, which blocks a family of KRAS proteins that help some cancers grow. It was given alone or with other drugs to 47 people with advanced solid tumors (like lung, colon, or pancreatic cancer) that have KRAS mutations. The main goals were to check safety and find the right dose, but the study was stopped early, so results are limited.

What this could mean

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

Active substance
BGB-53038 (a Pan-KRAS inhibitor pill), sometimes combined with tislelizumab or cetuximab infusions
What this could lead to
If it works, this could point toward a new treatment option for several hard-to-treat cancers with KRAS mutations.
What could go wrong
This is a very early (phase 1) trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

47 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

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

Accepted

You do not need to have the condition being studied to take part.

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. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Participants must have evidence of a KRAS mutation or wild-type amplification (copy number ≥ 8) based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by local laboratory 4. Able to provide an archived tumor tissue sample or fresh biopsy sample. 5. ≥ 1 measurable lesion per RECIST v1.1. 6. Adequate organ function. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, for \> 7 days after the last dose of BGB-53038, \> 120 days after the last dose of tislelizumab, or \> 2 months after the last dose of cetuximab, whichever is later 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). Exclusion Criteria: 1. Participants with tumors harboring KRAS G12R mutation. 2. Participants who have prior therapy with other anti-RAS treatment, including, but not limited to, therapy targeting specific KRAS allele mutation inhibitors, pan-KRAS inhibitors, and other pan-RAS inhibitors 3. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable CNS metastases are eligible, provided they meet select criteria. 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 5. Participants with untreated chronic hepatitis B or chronic HBV carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening. Participants with active hepatitis C. 6. Participants with clinically significant infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

colorectal cancer esophageal adenocarcinoma gastric cancer gastroesophageal junction adenocarcinoma metastatic malignant neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Advanced colorectal cancer Advanced esophageal adenocarcinoma Advanced gastric cancer Advanced gastroesophageal junction cancer Advanced non-squamous non-small-cell lung cancer Advanced pancreatic ductal adenocarcinoma Metastatic solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148, Australia

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Monash Health

    Clayton, Victoria, VIC 3168, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500, United States

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California, 90089-1019, United States

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