Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Hematologic Neoplasms

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Hematologic Diseases

Chronic Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

BC3402 as a single agent via intravenous infusion once every 3-weeks

Subjects will receive BC3402 as a single agent via intravenous infusion once every 3-weeks (Q3W),the dose of BC3402 was calculated according to the dose group and body weight of the subjects.

BC3402 Injection

hui zeng, prof

Hui Zeng, Prof

This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.

The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks).

A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.

This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose.

The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks). The Cohort1 will be enrolled 1 patient initially.If this subject experience any Grade 2 or higher toxicity during the first cycle, unless definitely unrelated to BC3402,2 more patients will be accrued,and the standard "3+3" dose escalation algorithm will be followed thereafter , with each cohort enrolling 3 to 6 subjects. Cohorts 2 and 3 will follow the traditional 3+3 dose escalation design. Dose limiting toxicities will be assessed during the first cycle(i.e., total21 days). If ≥ 2 subjects experience a DLT at a given dose level, the MTD would have been exceeded, further dose escalation is not pursued, and the prior dose level is expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD.

A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.

A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BC3402 as a Single Agent in Patients With Myelodysplastic Syndrome SYNDR(MDS) and Chronic Myelomonocytic Leukemia(CMML)

The DLT for this study will be evaluated in the first cycle. The DLT will include any of the following adverse events that cannot be clearly attributed to other reasons and are judged to be related to BC3402.

1. Hematologic toxicity in the following cases:

   Hematologic toxicity ≥ grade 4 occurred in the first cycle, which could not be recovered to baseline value within 21 days after the occurrence, and bone marrow primordial cells\<5%.
2. Non hematologic toxicities:

   * Grade 2 above ALT and/or AST elevational concomitant grade 2 total bilirubin elevation(non biliary obstruction or other reasons);
   * QTcF interval \> 470 ms or longer than baseline \> 60 ms;
   * Grade 3 or above non-haematological toxicity;
3. Others Any ongoing toxicity (of any grade) not caused by disease progression that results in a delay of more than 2 weeks in the next scheduled cycle;

Biocity Biopharmaceutics Co., Ltd.

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

Subjects will receive BC3402 and Durvalumab in a treatment cycle.

Intravenous infusion, once every 2 weeks, 4 weeks/cycle.

BC3402 injection

Intravenous infusion, once every 4 weeks, 4 weeks/cycle.

Durvalumab injection

Jia Fan, MD

Tianshu Liu, MD

Phase Ib: Dose exploration: To assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of BC3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) Phase II: Dose Expansion: To assess the antitumor activity of BC3402 in combination with durvalumab in subjects with advanced HCC.

BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

A Phase Ib/II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma

To assess the incidence of dose limiting toxicity (DLT) events at different doses of BC3402 in combination with durvalumab in the treatment of advanced HCC

To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.

To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML	NCT05690425	Hematologic Mal...	BC3402 Injectio...	18 Years -	Biocity Biopharmaceutics Co., Ltd.
BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma	NCT06111326	Hepatocellular ...	BC3402 injectio... Durvalumab inje...	18 Years - 75 Years	Biocity Biopharmaceutics Co., Ltd.

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