A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.
About this trial
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign the informed consent form voluntarily and follow the protocol requirements;
Gender is not limited;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Disqualifiers
Chemotherapy, biological therapy, immunotherapy 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 fluorouracil or palliative radiotherapy within 2 weeks before the first dose; Chinese patent medicine within 2 weeks before the first administration;
History of severe cardiovascular and cerebrovascular diseases;
Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
active autoimmune and inflammatory diseases;
Trial design
Design model
Single group
Treatments tested in this trial
BL-M05D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: BL-M05D1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 21 days after the first dose2
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 .
Time frame
Up to 21 days after the first dose3
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-M05D1.
Time frame
Up to approximately 24 monthsSecondary outcomes
1
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-M05D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M05D1.
Time frame
Up to approximately 24 months2
Cmax
Maximum serum concentration (Cmax) of BL-M05D1 will be investigated.
Time frame
Up to approximately 24 months3
Tmax
Time to maximum serum concentration (Tmax) of BL-M05D1 will be investigated.
Time frame
Up to approximately 24 months4
T1/2
Half-life (T1/2) of BL-M05D1 will be investigated.
Time frame
Up to approximately 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov