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Advanced CancerPhase 1NCT06548672

A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer

A Phase 1 study testing BC3195 in people with Advanced Cancer and Metastatic Solid Tumor, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase Ia/Ib, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BC3195 in subjects with locally advanced or metastatic solid tumors in whom standard treatment has failed (either due to disease progression or intolerance). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Solid Tumor
What is being tested?
BC3195
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteUnited States
Study dates
24 Jun 2024to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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 confirmed by histology or cytology who have not benefitted from or are intolerant of available therapy(ies) associated with a reasonable likelihood to confer clinical benefit because of known CDH3 expression, including, albeit not limited to: HNSCC, ESCC, BC, NSCLC, EC, UC, CRC, OC, pancreatic cancer, and prostate cancer.
  • Agree to provide previously archived tumor tissue samples, or newly obtained core biopsy, or excisional biopsy of a previously unirradiated tumor lesion (formalin fixed, paraffin embedded tissue blocks)
  • Subjects with at least one measurable lesion according to RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Life expectancy ≥ 3 months
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  • Subjects with adequate organ function
  • Men or women of childbearing potential 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.
  • Patients voluntarily participate in the study and should provide a written informed consent.

Who cannot join

  • Pregnant or lactating women
  • Prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks before the first dose (whichever is shorter)
  • Subjects diagnosed with immunodeficiency within 7 days prior to the first dose of the study drug; or subjects who are receiving longterm systemic steroid therapy or any other form of immunosuppressive therapy
  • Previously received allogeneic tissue/solid organ transplantation
  • Patients who have received radiation therapy within 2 weeks prior to the start of study treatment or with a history of radiation pneumonitis.
  • Known active CNS metastases and/or cancerous meningitis. Subjects with previously treated brain metastases who meet the following conditions are permitted to participate in the study: radiologically stable, that is, repeat imaging shows no evidence of progression for at least 4 weeks, clinically stable, and no steroid therapy is required for at least 14 days prior to the first dose of study treatment
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  • Active viral infection requiring systemic therapy during the screening period
  • Clinically uncontrolled pericardial effusion, pleural effusion, or ascites at screening
  • Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
  • Hypertension that cannot be well-controlled with medical treatment. Not well-controlled is defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg (adjustment of hypertensive medication prior to study initiation is permitted, but the mean of the most recent three consecutive blood pressure records prior to study entry must be ≤150/90 mmHg [with at least 2- minute interval between each measurement])
  • Cardiovascular disease of clinical significance: Including New York Heart Association [NYHA] Class II-IV, congestive heart failure, second-degree or higher heart block, myocardial infarction within the past 3 months, unstable arrhythmia or unstable angina, marked QT interval prolongation (12-lead ECG showing baseline-corrected QTc interval >480 ms), cerebral infarction within 3 months, or having received PTCA or CABG within 6 months
  • Subjects with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy
  • Grade 2 or higher peripheral neuropathy. Other toxicities caused by prior anti-tumor therapy has not recovered to ≤ grade 1 (per CTCAE 5.0) (except for alopecia, pigmentation, and other events judged by the Investigator to be tolerable) or the level specified by the inclusion/exclusion criteria in this study
  • Subjects with any active infection that requires anti-infective therapy judged by the investigators
  • Known hypersensitivity or delayed hypersensitivity reactions to the same class and/or any components of BC3195
  • Subjects who received strong CYP3A4 inhibitors and Strong CYP3A4 inducers within 14 days or 5 half-lives whichever is shorter, before the first dose (refer to Appendix 7 for a list of strong CYP3A4 inhibitors and inducers)
  • 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. Contact the study team or a site near you to ask about taking part.

Eric Rowinsky, MD contact

908-883-0647

erowinsky@oncodrugs.com

United States1 site, 1 recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Giselle Dutcher, MD, giselle.dutcher@uhhospitals.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ia/Ib, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors

This is a phase Ia/Ib, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BC3195 in subjects with locally advanced or metastatic solid tumors in whom standard treatment has failed (either due to disease progression or intolerance). This study will consist of two parts: Dose escalation (Part 1) and dose expansion (Part 2). Each part will include a screening period, a treatment period, and follow-up period.

Being tested
BC3195
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BC3195Drug

    BC3195 is a novel antibody drug conjugate (ADC) targeting CDH3 (calcium-dependent adhesion 3). The payload, monomethyl auristatin E (MMAE), is a microtubule disrupting agent covalently attached to the antibody via a cleavable dipeptide linker Val-Cit (vc).

Study groups in NCT06548672
Study groupRoleWhat they receive
Part 1: Phase 1a Dose EscalationExperimentalParticipants will receive BC3195 administered as an intravenous infusion every 3 weeks (Q3W) or according to an alternative dosing regimen, as recommended by the safety monitoring committee (SMC). Multiple dose cohorts will be enrolled. Participants will be monitored for dose limiting toxicities (DLTs) during the DLT assessment period, lasting 21 days. The SMC will determine the recommended phase 2 dose (RP2D) to be administered in Part 2 based on the safety, tolerability, PK, and anti-tumor activity of BC3195
Receives: Drug: BC3195
Part 2: Phase 1b Dose ExpansionExperimentalParticipants will receive BC3195 at the RP2D identified in Phase 1a. Approximately 3 to 4 expansion cohorts will be enrolled using a Simon's 2-stage design. Expansion cohorts will focus on tumor types that may derive benefit from BC3195 treatment, including head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), breast cancer (BC), non-small cell lung cancer (NSCLC), endometrial cancer (EMC), urothelial cancer (UC), colorectal cancer (CRC), ovarian cancer (OC), pancreatic cancer, and prostate cancer.
Receives: Drug: BC3195

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs)

    Measured: First 21 days of treatment

  2. Determination of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)

    Measured: Day 1 of treatment through 30 days after the last dose

  3. Incidence and Severity of All Adverse Events (AEs)

    Measured: Screening through 12 weeks after the last dose

Secondary outcomes (13)

  1. Objective Response Rate (ORR)

    Assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1

    Measured: Day 1 of treatment through 6 weeks after the last dose

  2. Disease Control Rate (DCR)

    Proportion of subjects with CR, PR, and stable disease (SD)

    Measured: Day 1 of treatment through 6 weeks after the last dose

  3. Duration of Response (DoR)

    Defined as the time from the date when the measurement criteria were met for complete or partial response (whichever occurred first) until the date of the first observed PD or death of any cause

    Measured: Day 1 of treatment through 6 weeks after the last dose

  4. Time to Progression (TTP)

    Defined as the length of time from the start of treatment until first evidence of disease progression

    Measured: Day 1 of treatment through 6 weeks after the last dose

  5. Progression Free Survival (PFS)

    Defined as the time from which the subject is enrolled to the date of any recorded disease progression or the death of any cause

    Measured: Day 1 of treatment through 6 weeks after the last dose

  6. Overall Survival (OS)

    Defined as the time from Day 1 of dosing until the date of death from any cause assessed up to 100 months

    Measured: Patient consent until death Day 1 of dosing until the date of death from any cause assessed up to 100 months

  7. Area under the curve (AUC) of BC3195

    Area under the BC3195 time vs concentration curve

    Measured: Day 1 of dosing through 21 days post last dose

  8. Maximum concentration (Cmax) of BC3195

    Maximum concentration observed following dosing

    Measured: Day 1 of dosing through 21 days post last dose

  9. Time to reach maximum concentration (Tmax) of BC3195

    Time at which the maximum concentration of BC3195 is observed

    Measured: Day 1 of dosing through 21 days post last dose

  10. Half-life (t 1/2) of BC3195

    Time at which BC3195 concentration is reduced by one half

    Measured: Day 1 of dosing through 21 days post last dose

  11. Volume of distribution (Vd) of BC3195

    Volume of distribution

    Measured: Day 1 of dosing through 21 days post last dose

  12. Clearance (CL) of BC3195

    Volume of drug cleared in a period of time

    Measured: Day 1 of dosing through 21 days post last dose

  13. Immunogenicity indicators

    Anti-drug antibody (ADA)

    Measured: Day 1 of dosing through 30 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start24 Jun 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548672
Sponsor's protocol ID
BC3195-102
Status last verified
Aug 2024
First submitted
11 Jul 2024
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BC3195 in people with Advanced Cancer and Metastatic Solid Tumor, run by Biocity Biopharmaceutics Co., Ltd. at 1 site in United States.

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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 Aug 2024. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Rowinsky, MD (908-883-0647, erowinsky@oncodrugs.com), 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: First 21 days of treatment). 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?

On the ClinicalTrials.gov record for NCT06548672.

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 12 Aug 2024.

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