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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT03905148

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 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.

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

91 people

The number who actually took part.

Started

May 2019

Finished

Oct 2025

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

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

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

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, 2148, Australia

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • MD Anderson

    Houston, Texas, 77030, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • The Prince of Wales Private Hospital - Specialist Medical Randwick

    Randwick, New South Wales, 2031, Australia

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.