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RecruitingLast updated: 3 April 2024

HH3806-A101: This study is evaluating how safe, tolerable and effective a new potential treatment drug called HH3806 is in people with advanced solid cancer or relapsed/refractory non-Hodgkin's lymphomasA Phase I, Open-label, Multicenter, First in Human Study to Evaluate the Safety and Tolerability of HH3806 in Patients with Advanced Malignancies

Clinical summary


This study will be conducted for eleven dose levels. Participants will receive HH3806 once daily until disease progression. HH3806 will be administered as an oral capsule once daily for the duration of each 28-day treatment cycle without any study treatment interruption between each cycle. All participants will undergo additional tests (including blood tests, echocardiograms and imaging) to assess the effect of the treatment on their cancer, and to monitor for side effects.


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Trial sponsor

Tigermed Australia Pty Ltd

Scientific Title

A Phase I, Open-label, Multicenter, First in Human Study to Evaluate the Safety and Tolerability of HH3806 in Patients with Advanced Malignancies



1. Male and female patients 18years of age or older .
2. Provide informed consent voluntarily prior to initiation of any study-related procedures.
3. Tumor type criteria: Histologically or cytologically confirmed diagnosis of one of the following advanced malignancy:
a) Solid tumors that meet the following criteria:
- Measurable disease by RECIST v1.1 in at least 1 site with the exception of Castration-Resistant Prostate Cancer (CRPC), who may be enrolled with objective evidence of disease as per certain criteria; disease progression with the last line of therapy and at least one prior standard of care regimens, or for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients without treatment options available known to provide clinical benefit are also eligible
b) Relapsed/refractory NHL must have received at least 2 prior systemic therapies and there is no standard salvage regimen available.
4. Life expectancy greater than or equal to 3 months.
5. ECOG performance status less than or equal to 1.
6. Patient must have adequate organ function measured within 28 days of screening.


Patients are ineligible for this study if they meet any of the following criteria:
1. Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy, traditional Chinese medication with cancer indication or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is longer) prior to the first dose of the study drug and have recovered from the side effects of prior therapy.
2. Patients who had prior treatment with any BET inhibitor.
3. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
4. Any toxicities from prior treatment that have not recovered to baseline or less than or equal to NCI-CTCAE v5.0 Grade 1 before the start of study treatment, except for Adverse Events not considered a likely safety risk.
5. Patients who have been treated with any hematopoietic colony-stimulating growth factors 2 weeks prior to starting study drug.
6. Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients’ neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new abnormality is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for 3 months at least two weeks prior to entering the study with treatment dose no more than dexamethasone 4 mg daily or an equivalent dose of steroids).
7. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
8. Patients with prior immunodeficiency, or organ transplantation or patients after allogeneic stem cell transplantation if they are less than 100 days has elapsed from the day of transplantation, they are on any treatment for graft-versus-host disease, or they have not been off calcineurin inhibitors for at least 4 weeks are excluded.
9. A history of current evidence /risk of cataract.
10. Known HIV.
11. Active hepatitis B and hepatitis C.
12. Patients with clinically significant cardiovascular disease.
13. Any active malignancy 2 years before the first dose of study drugs, except for the specific cancer under investigation and any locally recurring cancer that has been treated with curative intent.
14. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication 14 days before the first dose of study drugs.
15. Unable or unwilling to swallow study medication or gastrointestinal condition which could impair absorption of study medication.
16. Patient has any other concurrent severe and/or uncontrolled medical condition such as active infection, unresolved bowel obstruction, or psychiatric disorders that would, in the investigator’s judgment, contraindicate patient participation in the clinical study.
17. Patients with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, acute lung disease, etc.
18. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
19. Activity gastrointestinal ulcers within 2 months.
20. Was administered a live vaccine 4 weeks before first dose of study drug.
21. Any diseases or medical conditions, at the investigator's discretion, that may be unstable or influence their safety or study compliance, including organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse.
22. Concurrent participation in another therapeutic clinical study.
23. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients.
24. Pregnant or breast-feeding patients. Women of childbearing potential will be enrolled only after a confirmed menstrual period. Breast-feeding women can become eligible for this study if she stops breast-feeding, however, cannot restart the breast-feeding on/after the completion of the study treatment.
25. Male and Female of childbearing potential not using effective contraception during the trial and within 6 months after the end of treatment.


  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria.

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

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