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BC3195 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Biocity Biopharmaceutics Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Active viral infection requiring systemic therapy during the screening period

Prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks before the first dose (whichever is shorter)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patient consent until death day 1 of dosing until the date of death from any cause assessed up to 100 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of BC3195 in patients with advanced solid tumors that have not responded to standard treatment. The study has two parts: dose escalation and dose expansion. Participants will

Who is the study for?

This trial is for adults with advanced or metastatic cancer who have not had success with standard treatments due to disease progression or intolerance. Participants must be able to perform daily activities with minimal assistance.

What is being tested?

The study tests BC3195's safety and effectiveness in two parts: first, finding the right dose (Part 1), then seeing how well it works at that dose (Part 2). Patients will go through screening, treatment, and follow-up periods.

What are the potential side effects?

As a phase Ia/Ib trial primarily assesses safety, specific side effects of BC3195 are being studied but may include typical reactions such as nausea, fatigue, allergic responses or more serious complications depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer hasn't improved with standard treatments due to CDH3 expression.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for a viral infection.

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I haven't had cancer treatment or experimental drugs within the last 4 weeks or 5 half-lives, whichever is shorter.

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I have not had radiation therapy in the last 2 weeks or suffered from radiation pneumonitis.

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I do not have uncontrolled fluid buildup in my chest or abdomen.

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I was diagnosed with a weak immune system recently or am on long-term steroids or immunosuppressants.

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I am currently being treated for an infection.

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I have received an organ or tissue transplant from another person.

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I have or had lung inflammation that needed steroids.

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My high blood pressure is not controlled by medication.

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I have a significant heart condition.

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I have moderate to severe nerve damage and other side effects from cancer treatment are mild or better.

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I do not have ongoing eye conditions that need treatment or any significant corneal disease.

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I haven't taken strong CYP3A4 drugs in the last 14 days or 5 half-lives, whichever is shorter.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patient consent until death day 1 of dosing until the date of death from any cause assessed up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patient consent until death day 1 of dosing until the date of death from any cause assessed up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and patient consent until death day 1 of dosing until the date of death from any cause assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Area under the curve (AUC) of BC3195

Clearance (CL) of BC3195

Disease Control Rate (DCR)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Phase 1b Dose ExpansionExperimental Treatment1 Intervention

Participants 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.

Group II: Part 1: Phase 1a Dose EscalationExperimental Treatment1 Intervention

Participants 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

0 / 15Eligibility criteria met