Clinical trials

The goal of this clinical study is to find the best way to combine the study drug BEBT-908 (ifupinostat hydrochloride for injection) with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for treating previously untreated peripheral T-cell lymphoma, and to find out whether this best combination is better than standard CHOP treatment alone. The main questions this study will try to answer are: What percentage of participants will respond well to treatment with BEBT-908 plus CHOP? Is BEBT-908 plus CHOP better than standard CHOP treatment? What medical problems will participants have while receiving this combination treatment? This study includes an Exploration Phase and an Expansion Phase. The Exploration Phase has 3 cohorts. All participants receive both BEBT-908 and CHOP, but the dosing arrangements differ across cohorts: the dose of BEBT-908 differs, the sequencing of administration differs, and whether participants continue with CHOP or transition to BEBT-908 depends on their tolerability to CHOP. Eligible participants will receive the combination treatment for their assigned cohort. After that, based on the results from all 3 cohorts in the Exploration Phase, one optimal cohort will be selected to proceed into the Expansion Phase. In the Expansion Phase, eligible participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to either the treatment group, receiving the optimal combination regimen identified in the Exploration Phase, or the control group, receiving 6 cycles of CHOP. This study design will help investigators find the best way to combine BEBT-908 and CHOP for treating previously untreated peripheral T-cell lymphoma, and check whether this optimal combination regimen is better than standard CHOP treatment.

Title: A Study to See if BEBT-209 Combined With Chemotherapy Works to Treat People With Triple-Negative Breast Cancer Researchers want to learn if a new drug called BEBT-209 works to treat people with a specific type of breast cancer. This cancer is called locally advanced or metastatic triple-negative breast cancer (TNBC). The study has two parts. In the first part, researchers want to see if the new drug combination can shrink tumors. In the second part, researchers want to see if this treatment helps people live longer. Researchers will put participants into two groups by chance. This is like flipping a coin. Group 1: Participants get BEBT-209 plus two chemotherapy drugs. These drugs are Carboplatin and Gemcitabine. Group 2: Participants get only the two chemotherapy drugs. Researchers will group people based on the treatments they had in the past. Researchers will also check: How long the treatment keeps the cancer from growing. This is called progression-free survival (PFS). If the treatment is safe. Researchers will look for adverse events (AE), such as low blood cell counts. How participants feel. This is called health-related quality of life (HRQoL). How the body uses the drug.

This Phase I/II clinical trial is designed to evaluate, through a single-dose Phase I segment and a multiple-dose Phase II segment, the safety/tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) characteristics of BEBT-701 administered by subcutaneous injection in patients with mild to moderate hypertension and elevated LDL-C , and to explore its preliminary efficacy.

This is a multicenter, open-label Phase I clinical trial of BEBT-507 in subjects with polycythemia vera(PV). Phase Ia is a single-agent dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of BEBT-507 in subjects with PV . Based on the results of Phase Ia, two doses will be selected for further evaluation in Phase Ib to assess the efficacy, safety, and PK profile of BEBT-507 in subjects with PV , and to recommend a dose for Phase III clinical trials.

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer.

This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \[Standard of Care (SOC)\] \[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\] for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).

This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.

This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).

This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.