Solid Tumor, Urinary System Tumor
Conditions
Brief summary
Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.
Detailed description
Phase IIa: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors such as locally advanced or metastatic urinary system tumors, and further determine RP2D. The preliminary efficacy, pharmacokinetic characteristics and immunogenicity of BL-B01D1 were evaluated. Phase IIb: To explore the efficacy of BL-B01D1 as a single agent RP2D obtained in a Phase IIa clinical study. To evaluate the safety and tolerability, pharmacokinetic characteristics and immunogenicity of BL-B01D1.
Interventions
DRUGBL-B01D1
Administration by intravenous infusion
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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; 4. Expected survival time ≥3 months; 5. Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which standard treatment is currently unavailable or unavailable; 6. Testosterone levels in prostate cancer \< 1.73 nmol/L (50 ng/dL), disease progression before screening, according to the PCWG3 consensus; 7. Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years. If the subjects cannot provide tumor tissue samples, they can be enrolled after the evaluation of the investigators if they meet other inclusion and
Exclusion criteria
; 8. At least one measurable lesion (other than prostate cancer), as defined by RECIST v1.1, was required; 9. ECOG 0 or 1; 10. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 12. With adequate organ function; 13. For premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase IIa: Recommended Phase II Dose (RP2D) | Up to approximately 24 months | 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-B01D1. |
| Phase IIb: Objective response rate (ORR) | Up to approximately 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase IIa/IIb: Treatment-Emergent Adverse Event (TEAE) | Up to approximately 24 months | 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-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1. |
| Phase IIa: Objective response rate (ORR) | Up to approximately 24 months | 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. |
| Phase IIb: Progression-free survival (PFS) | Up to approximately 24 months | The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first. |
| Phase IIa/IIb: Disease control rate (DCR) | Up to approximately 24 months | 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 \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). |
| Phase IIa/IIb: Duration of response (DOR) | Up to approximately 24 months | 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. |
| Phase IIa/IIb: Cmax | Up to approximately 24 months | Maximum serum concentration (Cmax) of BL-B01D1 will be investigated. |
| Phase IIa/IIb: Tmax | Up to approximately 24 months | Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated. |
| Phase IIa: T1/2 | Up to approximately 24 months | Half-life (T1/2) of BL-B01D1 will be investigated. |
| Phase IIa: AUC0-t | Up to approximately 24 months | Blood concentration - Area under time line. |
| Phase IIa: CL | Up to approximately 24 months | To study the serum clearance rate of BL-B01D1 per unit time. |
| Phase IIa/IIb: Ctrough | Up to approximately 24 months | Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered. |
| Phase IIa/IIb: Anti-drug antibody (ADA) | Up to approximately 24 months | Frequency and titer of anti-BL-B01D1 antibody (ADA) will be evaluated. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
PRINCIPAL_INVESTIGATORDingwei Ye, PHD
Fudan University
Outcome results
None listed