Locally Advanced or Metastatic Solid TumorsPhase 1BC3195NCT05957471
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing Drug: BC3195 for Injection in people with Locally Advanced or Metastatic Solid Tumors, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- Drug: BC3195 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2023to Jun 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in the study and should provide a written informed consent.
- Male or female patients ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement.
- Life expectancy ≥ 3 months.
- Subjects with adequate organ function.
- Men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug.
Who cannot join
- Pregnant or lactating women.
- Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).
- Active viral infection requiring systemic therapy during the screening period.
- Hypertension that cannot be well-controlled with medical treatment.
- Cardiovascular disease of clinical significance.
- Subjects with any active infection that requires anti-infective therapy judged by the investigators.
- Subjects are not suitable for participating the study judged by the investigators.
- Subjects with poor compliance, who are unwilling to or unable to follow study procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Yilong Wu, 021-38804518 ext. 22132, syylwu@live.cn
Huajun Chen, 021-38804518 ext. 22132, chenhuajun@gdph.org.cn
About this study
Official title: A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
Read the detailed description
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles.
A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion.
- Being tested
- Drug: BC3195 for Injection
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: BC3195 for InjectionDrug
BC3195 via intravenous(IV).
| Study group | Role | What they receive |
|---|---|---|
| BC3195 treatment group. | Experimental | BC3195 via intravenous(IV). Receives: Drug: Drug: BC3195 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs) .
Measured: Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start26 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957471
- Sponsor's protocol ID
- BC3195-101
- Acronym
- BC3195
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 24 Jul 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05957471
- Acronym / sponsor ID
- BC3195 / BC3195-101
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Jul 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.
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
Detailed description
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles.
A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BC3195 treatment group. | Experimental | Drug: Drug: BC3195 for InjectionBC3195 via intravenous(IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients voluntarily participate in the study and should provide a written informed consent.
- Male or female patients ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement.
- Life expectancy ≥ 3 months.
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).
- Active viral infection requiring systemic therapy during the screening period.
- Hypertension that cannot be well-controlled with medical treatment.
- Cardiovascular disease of clinical significance.
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 |
|---|---|---|
| Drug: BC3195 for InjectionBC3195 via intravenous(IV). | Drug | BC3195 treatment group. |
Primary outcome
Incidence of dose limiting toxicities (DLTs) .
Time frame: Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug: BC3195 for Injection in people with Locally Advanced or Metastatic Solid Tumors, 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 8 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 24 Jul 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 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.
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 Yilong Wu (021-38804518 ext. 22132, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) . (time frame: Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).). 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 24 Jul 2023.