New pill targets Hard-to-Treat lymphoma in early human test
NCT ID NCT05824585
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This early-stage trial tests an experimental oral drug called DZD8586 in adults with B-cell Non-Hodgkin lymphoma that has returned or stopped responding to standard treatments. The study aims to find a safe dose and check whether the drug can shrink tumors. Participants take the pill once daily, and researchers monitor side effects, drug levels in the body, and anti-cancer activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DZD8586
- What this could lead to
- If successful, this could lead to a new oral treatment option for people with B-cell Non-Hodgkin lymphoma who have not responded to other therapies.
- What could go wrong
- This is an early Phase 1 trial with only 17 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.
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
-
17 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Jun 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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants who have provided ICF with age ≥ 18 yrs 2. ECOG performance 0-2, no deterioration in the past 2 weeks 3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma 4. Adequate bone marrow reserve and organ system functions 5. Participants willing to comply with contraceptive restrictions Exclusion Criteria: 1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia. 2. Prior history of allogeneic hematopoietic stem cell transplantation 3. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks 4. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months 5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions. 6. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy." 7. Participants with infectious disease: 8. Clinically significant cardiac disorders or abnormalities 9. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. 10. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption 11. Women who are breast feeding 12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
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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
-
Research site
New York, New York, 10065, United States
-
Research site
Albury, New South Wales, Australia
-
Research site
Ballarat, Victoria, Australia
-
Research site
Melbourne, Victoria, Australia
-
Research site
Perth, Western Australia, Australia
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