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Metastatic Solid TumorsPhase 1NCT06585488

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

A Phase 1 study testing BGB-53038, Tislelizumab and Cetuximab in people with Metastatic Solid Tumors and Advanced Non-squamous Non-small-cell Lung Cancer, run by BeOne Medicines at 17 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
BGB-53038, Tislelizumab and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
17 sitesin 5 countries
Study dates
13 Dec 2024to 23 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • 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
  • Able to provide an archived tumor tissue sample or fresh biopsy sample.
  • ≥ 1 measurable lesion per RECIST v1.1.
  • Adequate organ function.
  • 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
  • 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).

Who cannot join

  • Participants with tumors harboring KRAS G12R mutation.
  • 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
  • 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.
  • 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).
  • 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.
  • 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.

Trial locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

South Korea5 sites

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

Other trials in South Korea

United States4 sites

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland, 21287

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California, 90089-1019

Other trials in United States

Australia4 sites

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

Other trials in Australia

China3 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

Other trials in China

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

Being tested
BGB-53038, Tislelizumab, Cetuximab
Keywords
KRAS wild type amplification, Metastatic Solid Tumors, Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Colorectal Cancer, Advanced Pancreatic Ductal Adenocarcinoma, Advanced Gastric Cancer, Advanced Gastroesophageal Junction Cancer, Advanced Esophageal Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-53038Drug

    Administered orally

  • TislelizumabDrug

    Also called Tevimbra

    administered by intravenous infusion

  • CetuximabDrug

    administered by intravenous infusion

Study groups in NCT06585488
Study groupRoleWhat they receive
Phase 1a: Part A (Monotherapy Dose Escalation)ExperimentalSequential cohorts will be evaluated to determine the Recommended Dose for Expansion (RDFE) of BGB-53038 as a monotherapy.
Receives: Drug: BGB-53038
Phase 1a: Part B (Monotherapy Safety Expansion)ExperimentalParticipants will be enrolled at dose levels determined in Part A with the Safety Monitoring Committee to confirm the final RDFE(s) for BGB-53038 monotherapy.
Receives: Drug: BGB-53038
Phase 1a: Part C (Combination Therapy Dose Escalation)ExperimentalSequential cohorts with increasing doses will be evaluated to determine the RDFE(s) for BGB-53038 in combination with tislelizumab or cetuximab.
Receives: Drug: BGB-53038; Drug: Tislelizumab; Drug: Cetuximab
Phase 1b: Part D (Monotherapy Dose Expansion)ExperimentalParticipants will be enrolled to receive the RDFE(s) of BGB-53038 monotherapy
Receives: Drug: BGB-53038
Phase 1b: Part E (Combination Therapy Dose Expansion)ExperimentalParticipants will be enrolled to receive BGB-53038 at the RDFE(s) as determined in Part C of Phase 1a in combination with tislelizumab and in combination with cetuximab, respectively.
Receives: Drug: BGB-53038; Drug: Tislelizumab; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCICTCAE] Version [v] 5.0), timing, seriousness, and relationship to study drug(s); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Measured: Up to approximately 2 years

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038

    defined as the highest dose at which 30% of the participants experienced a DLT or the highest dose administered, respectively.

    Measured: Up to approximately 2 years

  3. Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-53038

    The potential RDFE(s) of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available.

    Measured: Up to approximately 2 years

  4. Phase 1b: Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1

    Measured: Up to approximately 2 years

  5. Phase 1b: Recommended Phase 2 Dose (RP2D) of BGB-53038

    The RP2D of BGB-53038 as monotherapy or in combination with other antitumor therapies (tislelizumab or cetuximab) will be determined based on safety, long-term tolerability, PK, preliminary antitumor activity, and any other relevant data, as available

    Measured: Up to approximately 2 years

Secondary outcomes (12)

  1. Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038

    Measured: Up to approximately 2 years

  2. Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038

    Measured: Up to approximately 2 years

  3. Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038

    Measured: Up to approximately 2 years

  4. Phase 1a: Single-dose and steady-state trough concentration (Ctrough) of BGB-53038

    Measured: Up to approximately 2 years

  5. Phase 1b: ORR

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.

    Measured: Up to approximately 2 years

  6. Duration of Response (DOR)

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

    Measured: Up to approximately 2 years

  7. Time to Response (TRR)

    defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

  8. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) lasting ≥ 24 weeks as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

  9. Progression Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.

    Measured: Up to approximately 2 years

  10. Phase 1b: Overall Survival (OS)

    defined as the time from the date of first dose of study drug until the date of death from any cause

    Measured: Up to approximately 2 years

  11. Phase 1b: Number of Participants Experiencing Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) characterized by type, frequency, severity (as graded by the NCI-CTCAE v5.0), timing, seriousness, and relationship to study drug(s)

    Measured: Up to approximately 2 years

  12. Plasma concentrations of BGB-53038

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2024
  2. Study start13 Dec 2024
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

Why it stopped: The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585488
Sponsor's protocol ID
BGB-53038-101
Other IDs
2024-514704-13-00
Status last verified
Jun 2026
First submitted
3 Sep 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB-53038, Tislelizumab and Cetuximab in people with Metastatic Solid Tumors and Advanced Non-squamous Non-small-cell Lung Cancer, run by BeOne Medicines at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Korea, United States, Australia, China, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06585488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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