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RecruitingLast updated: 31 January 2024

This Phase I/II trial is trying to determine the safety and recommended dose of two drugs (PD-0325901 and BGB-283) given in combination for the treatment of advanced solid cancersA Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

Clinical summary

Summary

This trial consists of two parts. In part A, dose escalation and expansion, participants will receive increasing doses of PD-0325901 and BGB-283 in order to establish the maximum tolerated dose and/or recommended part B dose. In part B, participants will be stratified according to select tumour types and/or characteristics. This part of the trial will continue to evaluate the safety, tolerability and and Pharmacokinetics ot the combination of PD-0325901 and BGB-283.

Conditions

This trial is treating patients with non-small cell lung cancer, colorectal cancer, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other solid cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

Eligibility

Inclusion

  1. Able to provide informed consent
  2. Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place
  3. Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression

    • Part A: NSCLC, CRC, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other)
    • Part B: NRAS mutated solid tumors must have a known mutation status and a histologically or cytologically confirmed advanced or refractory solid tumor. Up to 40% Melanoma and Up to 20% CRC.
  4. Must have archival tumor tissue or agree to tumor biopsy
  5. Measurable disease per RECIST 1.1
  6. Eastern Cooperative Oncology Group performance status of less than or equal to 1
  7. Life expectancy is greater than 12 weeks of the signing of ICF.
  8. Adequate organ function and no transfusion within 14 days of first dose.
  9. Females are of non-child bearing potential or willing to use contraception.
  10. Males vasectomized or agree to use contraception.

Exclusion

  1. Central Nervous System metastasis
  2. Any retinal pathology considered to be a risk factor for central serous retinopathy
  3. History of glaucoma
  4. Active parathyroid disorder or history of malignancy associated hypercalcemia
  5. Clinically significant cardiac disease within the past 6 months of signing ICF.
  6. LVEF less than 50%
  7. Abnormal QT interval at Screening
  8. Severe uncontrolled systemic disease
  9. HIV
  10. Clinically significant active or known history of liver disease. (Hepatitis B and Hepatitis C)
  11. Hemorrhage or bleeding event at NCI-CTCAE v5.0 Grade 3 or higher within 28 days of first dose.
  12. history of or ongoing Von Willebrand disease and/or other past or present bleeding disorders
  13. Increased serum calcium
  14. Inability to swallow oral medications
  15. Ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks. No chemotherapy, immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
  16. Concomitant systemic or glucocorticoid therapy within 2 weeks
  17. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
  18. Concomitant medicines that are strong CYP3A inhibitors
  19. History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these drugs
  20. Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
  21. Has been administered a live vaccine within 4 weeks (28 days) of initiation of study treatment. NOTE: injectable seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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