Hepatocellular CarcinomaPhase 1/2NCT06111326
BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing BC3402 injection and Durvalumab injection in people with Hepatocellular Carcinoma, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- BC3402 injection and Durvalumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study and sign an informed consent form;
- Male or female aged ≥ 18 years and ≤ 75 years;
- Patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by American Association for the Study of Liver Disease (AASLD) (2018 edition);
- ECOG performance status of 0 or 1;
- HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment;
- Adequate organ and marrow function;
- Male or female subjects with childbearing potential must agree to use reliable contraceptive methods.
Who cannot join
- Received local hepatic therapy within 4 weeks prior to initiation of the study drug;
- History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy;
- The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage.
- The subject has main portal vein thrombosis on baseline imaging;
- Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement;
- Current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug;
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- Prior treatment with any anti-TIM3 antibody;
- Prior treatment with an anti-PD-1 or anti PD-L1 immune checkpoint inhibitor antibody (only applicable for dose expansion part).
- Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai
Tianshu Liu, MD, +86 13681973996, liu.tianshu@zs-hospital.sh.cn
About this study
Official title: 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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- BC3402 injection, Durvalumab injection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC3402 injectionDrug
Intravenous infusion, once every 2 weeks, 4 weeks/cycle.
Durvalumab injectionDrug
Intravenous infusion, once every 4 weeks, 4 weeks/cycle.
| Study group | Role | What they receive |
|---|---|---|
| BC3402+Durvalumab | Experimental | Subjects will receive BC3402 and Durvalumab in a treatment cycle. Receives: Drug: BC3402 injection; Drug: Durvalumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events
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
Measured: 28 Days
Phase Ib: Dose Exploration Part-Safety
To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.
Measured: 2 years
Phase II: Dose Expansion Part-objective response rate (ORR)
To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startOct 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111326
- Sponsor's protocol ID
- BC3402-105
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06111326
- Acronym / sponsor ID
- BC3402-105
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BC3402+Durvalumab | Experimental | Drug: BC3402 injection, Drug: Durvalumab injectionSubjects will receive BC3402 and Durvalumab in a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing to participate in the study and sign an informed consent form;
- Male or female aged ≥ 18 years and ≤ 75 years;
- Patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by American Association for the Study of Liver Disease (AASLD) (2018 edition);
- ECOG performance status of 0 or 1;
- HBV Patients with HBV infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment;
Key exclusion criteria (9 listed)
- Received local hepatic therapy within 4 weeks prior to initiation of the study drug;
- History of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy;
- The subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage.
- The subject has main portal vein thrombosis on baseline imaging;
- Documented history of GI bleeding within the past 6 months or at a high risk of GI bleeding per the investigator's clinical judgement;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BC3402 injectionIntravenous infusion, once every 2 weeks, 4 weeks/cycle. | Drug | BC3402+Durvalumab |
| Durvalumab injectionIntravenous infusion, once every 4 weeks, 4 weeks/cycle. | Drug | BC3402+Durvalumab |
Primary outcome
Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events
Time frame: 28 Days
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
Phase Ib: Dose Exploration Part-Safety
Time frame: 2 years
To assess the AEs of BC3402 in combination with durvalumab in the treatment of advanced HCC.
Phase II: Dose Expansion Part-objective response rate (ORR)
Time frame: 2 years
To assess the ORR of BC3402 in combination with durvalumab in advanced hepatocellular carcinoma (according to RECIST v1.1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Fan, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BC3402 injection and Durvalumab injection in people with Hepatocellular Carcinoma, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Fan, MD (+86021-64041990, fan.jia@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Dose Exploration Part-The incidence of dose limiting toxicity (DLT) events (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.