New drug combo targets Hard-to-Treat cancers in early trial
NCT ID NCT03905148
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of two experimental drugs (BGB-283 and PD-0325901) in 91 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and see if the drugs could shrink tumors. The trial is now complete, and results will help decide if further studies are warranted.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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91 people
The number who actually took part.
- Started
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May 2019
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148, Australia
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Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
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MD Anderson
Houston, Texas, 77030, United States
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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The Prince of Wales Private Hospital - Specialist Medical Randwick
Randwick, New South Wales, 2031, Australia
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University of California Los Angeles
Santa Monica, California, 90404, United States
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Other studies related to the condition(s) this trial covers.
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