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Clinical Trial NCT06493864 for Breast Cancer, Solid Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors Phase 1 21 Randomized

Recruiting
Clinical Trial NCT06493864 is designed to study Treatment for Breast Cancer, Solid Tumor. It is a Phase 1 interventional study that is recruiting, having started on August 26, 2024, with plans to enroll 21 participants. Led by Sichuan Baili Pharmaceutical Co., Ltd., it is expected to complete by July 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 18, 2025.
Brief Summary
This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.
Official Title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumor

Conditions
Breast CancerSolid Tumor
Other Study IDs
  • BL-B16D1-103
NCT ID Number
NCT06493864
Start Date (Actual)
2024-08-26
Last Update Posted
2025-09-18
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
21
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBL-B16D1
Participants receive BL-B16D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
BL-B16D1
Administration by intravenous infusion for a cycle of 3 weeks.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Phase Ia: Dose limiting toxicity (DLT)
DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.
Up to 21 days after the first dose
Phase Ia: Maximum tolerated dose (MTD)
MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .
Up to 21 days after the first dose
Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B16D1.
Up to approximately 24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B16D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B16D1.
Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-B16D1 will be investigated.
Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-B16D1 will be investigated.
Up to approximately 24 months
T1/2
Half-life (T1/2) of BL-B16D1 will be investigated.
Up to approximately 24 months
AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Up to approximately 24 months
CL (Clearance)
CL in the serum of BL-B16D1 per unit of time will be investigated.
Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-B16D1 prior to the next dose will be administered.
Up to approximately 24 months
ADA (anti-drug antibody)
Frequency of anti-BL-B16D1 antibody (ADA) will be investigated.
Up to approximately 24 months
Phase Ib: Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Up to approximately 24 months
Phase Ib: Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
Up to approximately 24 months
Phase Ib: Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Up to approximately 24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Sign the informed consent form voluntarily and follow the protocol requirements;
  2. Gender is not limited;
  3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
  4. Expected survival time ≥3 months;
  5. Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors who failed or could not receive standard treatment;
  6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;
  7. Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition;
  8. ECOG 0 or 1;
  9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose;
  12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
  13. Urinary protein ≤2+ or ≤1000mg/24h;
  14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.

  1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
  2. History of severe heart disease;
  3. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block;
  4. Active autoimmune and inflammatory diseases;
  5. Patients with other malignant tumors or a history of other malignant tumors;
  6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
  7. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
  8. Patients with poor glycemic control;
  9. Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;
  10. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
  11. Patients with primary central nervous system (CNS) tumors or CNS metastases that had failed local treatment;
  12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B16D1's excipients;
  13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
  14. In previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin > 550 mg/m2, epirubicin > 900 mg/m2 or the equivalent dose of other similar drugs;
  15. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
  16. Serious infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
  17. Patients with massive or symptomatic effusions, or poorly controlled effusions;
  18. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
  19. Had the following eye diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;
  20. Other circumstances that the investigator deemed inappropriate for participation in the trial.
Sichuan Baili Pharmaceutical Co., Ltd. logoSichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. logoBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study Central Contact
Contact: Sa Xiao, PHD, 15013238943, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China
Jiong Wu, Contact
Jiong Wu, Principal Investigator
Jian Zhang, Principal Investigator
Recruiting