An Exploratory Clinical Study of BC006 in Patients With Advanced Solid Tumors

NCT05212896 | Unknown Phase 1

• 1 other identifier: BC006-Ⅰ-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage. It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BC006 in giant cell tumor of tendon sheath (GCTTS) and other advanced solid tumors.

Conditions

Advanced Solid Tumors (Including GCTTS)

Outcome Measures

Primary Outcomes (5)

• Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

  Dose Escalation: Phase Ia

  Up to 28 days

• Maximum Tolerated Dose (MTD) of BC006

  Dose Escalation: Phase Ia

  Up to 28 days

• Recommended Dose for Expansion (RDE) of BC006

  Dose Escalation: Phase Ia

  Through study completion, an average of 1 year

• Number of Participants with TEAEs

  Graded according to the NCI CTCAE V5.0

  Through study completion, an average of 1 year

• Number of Participants with SAEs

  Graded according to the NCI CTCAE V5.0

  Through study completion, an average of 1 year

Secondary Outcomes (10)

• Cmax

  From first dose of BC006, an average of 6 months

• Tmax

  From first dose of BC006, an average of 6 months

• AUC0-t

  From first dose of BC006, an average of 6 months

• t1/2

  From first dose of BC006, an average of 6 months

• Pharmacodynamic (PD) Parameters

  From first dose of BC006, an average of 6 months

Study Arms (3)

Dose Escalation: Phase Ia

EXPERIMENTAL

Participants will receive escalating doses of BC006 at assigned dose (0.08, 0.3, 1.0, 3.0, 10, 20 mg/kg) via intravenous (IV) infusion every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first.

Drug: BC006

Dose Expansion: Phase Ib Cohort 1

EXPERIMENTAL

Participants with GCTTS will receive BC006 at recommended dose for expansion (RDE) IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 24 weeks of treatment, whichever occurs first.

Drug: BC006

Dose Expansion: Phase Ib Cohort 2~4

EXPERIMENTAL

Participants with other solid tumors will receive BC006 at RDE IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first.

Drug: BC006

Interventions

BC006 DRUG

BC006 monoclonal antibody injection

Dose Escalation: Phase Ia; Dose Expansion: Phase Ib Cohort 1; Dose Expansion: Phase Ib Cohort 2~4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age ≥ 18 years.
• Clinical diagnosis:
• Dose Escalation: Phase Ia
• Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
• Patients with histologically or cytologically confirmed advanced solid tumor, who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
• Dose Expansion: Phase Ib
• Cohort 1: Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
• Cohort 2\~4: Patients with histologically or cytologically confirmed advanced solid tumor which is sensitive to Ia treatment，who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
• Life expectancy ≥ 12 weeks.
• Ia: at least one evaluable lesion; Ib: at least one measureable lesion as defined by RECIST V1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Evidence of adequate organ function by standard laboratory tests:
• Adequate hematological function: Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets (Plts) ≥ 90 × 109/L.
• Adequate liver function: Total bilirubin ≤ 1.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤ 2.5 × ULN (AST≤ 5 × ULN, ALT≤ 5 × ULN for subjects with liver metastases).

You may not qualify if:

• Prior anti-tumor therapies such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, immunotherapy or other investigational agents within 4 weeks before the first dose of BC006.
• Prior treatment with any anti-CSF-1R inhibitor.
• Any toxicity from previous anti-tumor treatments have not recovered to CTCAE V5.0 grade ≤ 1 (except treatment-related alopecia).
• Patients with untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or patients with evidence that brain and spinal cord metastases have not been controlled (Patients with previously treated brain metastases may participate provided they are clinically and imaging stable for at least 4 weeks prior to first dose of BC006, have no evidence of cerebral edema and are off steroids).
• Patients with severe cardiovascular diseases: cardiac arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other ≥ grade 3 cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function ≥ grade II or left ventricular ejection fraction (LVEF) \<50%; poorly controlled hypertension as judged by the investigator are not suitable to participate in the study.
• Receipt of a live vaccine within 4 weeks prior to the first dose of BC006 or anticipation that such a live vaccine will be required during the study.
• Patients with symptomatic pleural, abdominal, or pericardial effusions that require repeated puncture and drainage treatment and cannot be relieved; patients with stable disease after receiving treatment (including therapeutic thoracentesis or abdominal puncture) are allowed to enroll.
• In the opinion of the investigator, patients have any clinical or laboratory examination abnormality or other conditions that are not suitable to participate in the study.

Sponsors & Collaborators

• Dragonboat Biopharmaceutical Company Limited: lead
• West China Hospital: collaborator

Study Sites (1)

Dragonboat Biopharmaceutical,Co.,Ltd

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Li Zheng

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Yuan Peng

CONTACT

#86#021-50276381; yuan.peng@dragonboatbio.com

Ting Yan

CONTACT

#86#021-50276381; ting.yan@dragonboatbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 28, 2022
• Study Start: November 26, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 28, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)