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Tests treatment safety and results for FL Lymphoma
Official title Evaluate the Safety and Clinical Activity of HH2853
ClinicalTrials.gov ID: NCT04390737
What this study is testing
What is HH2853 Tablets?
HH2853 Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fl lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provided signed written informed consent prior to initiation of any study-related procedures;
- Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);
- Tumor type criteria: The specific requirements for specific subtypes of recurrent/refractory non Hodgkin's lymphoma (NHL) confirmed by histology are...
- Histologically or cytologically documented advanced recurrent or metastatic solid tumor.
- Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target...
You likely can't join if
- Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five...
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Patients with prior transplant are excluded;
- Major surgery within 4 weeks prior to first dose;
- A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;
- HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥...
See the full eligibility criteria
- Provided signed written informed consent prior to initiation of any study-related procedures;
- Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);
- Tumor type criteria: The specific requirements for specific subtypes of recurrent/refractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows: Histologically confirmed follicular lymphoma (FL) that has...
- Histologically or cytologically documented advanced recurrent or metastatic solid tumor.
- Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been...
- Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met. Patients must experience at least one prior standard...
- Confirmed by local histology or cytology
- Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity). For solid tumors in Phase I and...
- Confirmed by local pathology as advanced recurrent or metastatic solid tumor.
- Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue...
- Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Patients with prior transplant are excluded;
- Major surgery within 4 weeks prior to first dose;
- A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;
- HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\^3 copies or ≥ 200 IU/mL; HCV antibody test results are positive...
- Concomitant malignancies or previous malignancies
- Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.
- Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1
- There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet/antithrombotic drugs.
- Gastrointestinal condition which could impair absorption of study medication;
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;
- Cardiac exclusion criteria: 1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- San Antonio, Texas, United States
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Beijing, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; San Antonio, Texas, United States; Hefei, Anhui, China; Beijing, Beijing Municipality, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.