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Trial Title:
A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors
NCT ID:
NCT06143007
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
BB3008
HPK1
First-in-Human
Dose Escalation
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BB3008 tablet
Description:
BB3008 tablets will be administered orally once daily (QD).
Arm group label:
BB3008 monotherapy
Other name:
BB3008
Summary:
This is a Phase 1 dose escalation study to evaluate the safety, tolerability,
pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in
subjects with advanced solid tumors.
Detailed description:
This first-in-human (FIH) study of BB3008 will evaluate safety, tolerability,
pharmacokinetics (PK) efficacy and preliminary food effect of BB3008 in subjects with
advanced solid tumors. The primary objective is to determine the maximum tolerated dose
(MTD) and the recommended phase II dose (RP2D) of BB3008 as monotherapy, and to evaluate
the safety and tolerability of BB3008. The secondary objectives include the assessments
of PK profile, preliminary efficacy, preliminary food effect (FE) and preliminary
metabolites identification of BB3008. The exploratory objectives are to explore
biomarkers and C-QTcF analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Fully informed of the study and voluntarily signed the informed consent form (ICF),
and willing to follow and have the ability to complete all trial procedures.
2. Subjects with histologically or cytologically confirmed advanced solid tumors who
are lacking standard therapy, progressing after adequate standard therapy, or
intolerant of standard therapy.
3. ECOG score ≤1.
4. At least one evaluable or measurable lesion as defined by RECIST v1.1.
5. Expected survival ≥ 3 months.
6. adequate organ function.
7. Female subjects of childbearing potential must have a negative pregnancy test prior
to the first dose and are required to use effective contraception from signing the
ICF until 6 months after the last dose of study treatment.
Exclusion Criteria:
1. History of dual-source cancer within 5 years.
2. Presence of known active central nervous system (CNS) and/or leptomeningeal
metastases.
3. History of clinically serious cardiovascular and cerebrovascular disease within 6
months.
4. Active infection (including, but not limited to HBV or HCV).
5. Received radical radiotherapy within 12 weeks.
6. Received live virus vaccination within 4 weeks.
Gender:
All
Minimum age:
18 Years
Maximum age:
78 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Mengzhao Wang, MD
Phone:
+86-13911235467
Email:
Mengzhaowang@sina.com
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Huang, MD
Phone:
+86-13301056087
Email:
huangjingwg@163.com
Start date:
October 26, 2023
Completion date:
April 2026
Lead sponsor:
Agency:
BrodenBio Co., Ltd.
Agency class:
Industry
Source:
BrodenBio Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06143007
