RECRUITING

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

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Conditions

Metastatic Solid TumorsAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Colorectal CancerAdvanced Pancreatic Ductal AdenocarcinomaAdvanced Gastric CancerAdvanced Gastroesophageal Junction CancerAdvanced Esophageal AdenocarcinomaKRAS wild type amplification

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must sign a written ICF; and understand and agree to comply with the requirements of the study and the schedule of activities.
  2. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. 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. 4. Able to provide an archived tumor tissue sample or fresh biopsy sample.
  5. 5. ≥ 1 measurable lesion per RECIST v1.1.
  6. 6. Adequate organ function.
  7. 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. 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).
  1. 1. Participants with tumors harboring KRAS G12R mutation.
  2. 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. 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. 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. 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. 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.

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90033
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
United States
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

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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