Trial Title:
BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors
NCT ID:
NCT05869240
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
BPB101
solid tumor
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BPB-101
Description:
Subjects will receive an intravenous infusion of BPB-101 in a pre-set dose escalation
until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from
the trial.
Arm group label:
BPB-101
Summary:
This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy
in patients with advanced solid tumors to evaluate the safety, pharmacokinetic
characteristics and antitumor activity of BPB-101.
Detailed description:
This trial consist of 3 parts: dose escalation(phase Ia), dose expansion(phase Ib) and
clinical expansion(phase II) part. The current trial is composed of dose escalation with
accelerated titration and "3 + 3" cohort design (phase Ia), for which 1 to 6 subjects
will be enrolled at each dose level depending on the occurrence of dose limiting
toxicities (DLT), followed by a consecutive parallel-group expansion in selected dose
levels (phase Ib) and selected solid tumor indications (phase II). Participants enrolled
in Phase 2 will receive the Recommend Phase 2 Dose (RP2D) of BPB-101 (determined by phase
Ia dose escalation and phase Ib dose expansion) until confirmed progression, unacceptable
toxicity, or any criterion for stopping the study drug or withdrawal from the trial
occurs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in the trial and sign an informed consent form.
2. Male or female subjects aged between 18 and 75 years.
3. Subjects with cytologically or histologically confirmed advanced solid tumor for
which no standard therapy is available or standard therapy has failed in
dose-escalation phase; In the dose-expansion phase, subjects enrollment included,
but not limited to, with non-small-cell lung, esophageal, colorectal, endometrial,
melanoma, bladder, and breast cancers (actual enrollment could be determined based
on available data).
4. Life expectancy >= 12 weeks.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
6. Participants enrolled in the dose-escalation phase (phase Ia) must have evaluable
disease per RECIST 1.1. Participants enrolled in the dose expansion and clinical
expansion phase (phase Ib and II) must have at least one measurable disease per
RECIST 1.1.
7. Adequate hematologic and organ function at screening, as follows:
1. Absolute neutrophil count (ANC)≥1.5×10^9/L, Platelets≥100×10^9/L,
Hemoglobin≥9g/dL(90g/L)
2. Serum total bilirubin ≤1.5×upper limit of normal (ULN), unless liver cancer or
liver metastases are present, then values must be ≤2×ULN; Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, unless
liver cancer or liver metastases are present, then values must be ≤5×ULN
3. Serum creatinine≤1.5×ULN OR creatinine clearance (CrCl)≥50ml/min (using the
Cockcroft-Gault formula)
4. International normalized ratio (INR) and prothrombin time ≤1.5×ULN; And
activated partial thromboplastin time (aPTT) ≤1.5×ULN.
8. Female subjects with childbearing potential must have a negative serum pregnancy
test at screening (within 7 days of first dose of study drug). Female subjects with
childbearing potential and male subjects with a female partner(s) of childbearing
potential must agree to use highly effective contraceptive measures throughout the
trial starting with the screening visit through 6 months after the last dose of
study drug is received.
Exclusion Criteria:
1. Known hypersensitivity to any component and excipients of the investigational drug,
or previous severe allergic reaction to any macromolecular monoclonal antibody.
2. Received anti-PD-1 or PD-L1 antibodies within 3 months prior to screening.
Previously received treatment targeting TGF-β, TGF-β receptors, or GARP.
3. Received other antitumor therapies, such as chemotherapy, biological therapy,
endocrine therapy, etc., within 4 weeks before the first dose. Local palliative
treatment (such as local surgery or radiotherapy) for isolated lesions can be
received without affecting the efficacy evaluation. Enrollment is permitted in the
following cases:
- Oral pyrimidine or small molecule targeted therapy drugs are used more than 2
weeks or 5 half-lives of the drug (whichever is longer) before the first dose.
- Nitrosourea or mitomycin C are used more than 6 weeks before the first dose.
4. Major surgery within 4 weeks before first dose of study drug.
5. Systemic therapy with immunosuppressive agents within 2 weeks prior to the first
dose of study drug or during the study, except for corticosteroid nasal sprays,
inhalers, or ≤10 mg/day systemic prednisone and equivalent medications.
6. Previous malignant disease (other than the target malignancy to be investigated in
the trial) within the last 5 years.Except for malignancies that can be expected to
heal after treatment (including but not limited to, adequately treated thyroid
cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or
carcinoma in situ of the breast duct treated with radical surgery).
7. Presence of symptomatic central nervous system metastases, meningeal metastases, or
spinal cord compression due to metastases. Except for patients with brain metastases
who have symptoms before the first dose, but whose disease is stable for ≥ 4 weeks
after treatment.
8. Subjects with a clear bleeding tendency, such as gastrointestinal bleeding,
hemorrhagic gastric ulcer; Those with a history of melena and hematemesis within 2
months before administration; Researchers believe that visceral bleeding may occur.
9. Patients with large and uncontrolled pleural effusions, pericardial effusions, or
abdominal effusions requiring repeated drainage.
10. Has an active autoimmune disease requiring systemic treatment within 2 years prior
to initial medication.
11. Cardiovascular diseases of clinical significance, including:
a. Clinically uncontrolled hypertension;
The following conditions occurred within 6 months before the first medication:
1. Congestive heart failure (New York Heart Association Grade III or IV);
2. Arrhythmias or conduction abnormalities that require medical treatment. Note:
Subjects with drug-controlled atrial fibrillation/atrial flutter and pacemaker
controlled arrhythmia can be enrolled;
3. Severe/unstable angina, coronary/peripheral bypass graft, or myocardial
infarction; (Note: Severe angina is Grade III or IV of the Canadian
Cardiovascular Society)
4. Cerebrovascular accident or transient ischemic attack, transient myocardial
ischemia;
5. Any other arterial thrombosis or embolic event.
12. Severe active infection within 2 weeks prior to initial administration, or systemic
anti-infection therapy lasting more than 7 days after intravenous use within 1 week
prior to initial administration.
13. Toxicity due to previous antitumor therapy has not returned to CTCAE 5.0 level ≤1
(except for toxicity such as alopecia where the investigator determined no
safety-related risk).
14. There is active tuberculosis, or interstitial lung disease requiring treatment.
15. History of bone marrow allotransplantation or solid organ transplantation.
16. HIV-positive or active syphilis infection.
17. Have active hepatitis B and C.
18. Pregnant or lactating women.
19. Have received live or attenuated vaccine within 180 days prior to initial
administration of study drug (Note: Inactivated virus vaccine is allowed. Seasonal
flu vaccines that do not contain live viruses are allowed. Inactivated COVID-19
vaccine is allowed, but needs to be eluted for 1 week before first administration).
20. Any other disease or condition of clinical significance that the investigator
believes may affect protocol compliance or the subject's signing of informed
consent, or may be inappropriate for participation in the clinical trial.
21. Inability or unwillingness to follow the research and/or follow-up procedures
outlined in the programme.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Phone:
0086-13902282893
Email:
zhangli@sysucc.org.cn
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Suxia Luo
Phone:
0086-18638553211
Email:
luosxrm@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Keqiang Zhang
Phone:
0086-13054196067
Email:
zhangkeqiang@hnca.org.cn
Facility:
Name:
Sichuan Academy of Medical Sciences-Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Lan
Phone:
0086-18981838376
Email:
lanht@sina.com
Start date:
May 16, 2023
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Betta Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05869240
