To hear about similar clinical trials, please enter your email below
Trial Title:
BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors
NCT ID:
NCT06368960
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiation： Hypofractionated radiotherapy
Arm group label:
BM201 injection combined with radiotherapy
Arm group label:
Radiotherapy
Other name:
RT
Intervention type:
Drug
Intervention name:
BM201 injection
Description:
BM201 injection：Dose escalation：24mg to 240mg
Arm group label:
BM201 injection combined with radiotherapy
Other name:
BM201
Summary:
This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate
tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in
combination with radiotherapy in patients with histologically or cytologically confirmed
unresectable locally advanced or metastatic solid tumors who have failed standard therapy
or are unable to receive standard treatment.
Detailed description:
This is a Phase I, open-label clinical study primarily designed to evaluate the safety
and tolerability of BM201 injection in combination with radiotherapy in patients with
advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Unresectable advanced or metastatic solid tumors, either refractory to standard
therapy or ineligible for standard treatment.
2. ECOG performance status score of 0-2 point;
3. Expected survival of ≥3 months.
4. At least one measurable lesion by irRECIST criteria, and eligible for intratumoral
injection.
5. Prior anti-tumor treatments should be paused for at least 4 weeks before trial
initiation，with toxicity related to anti-cancer treatment recovered to ≤Grade 1.
6. Adequate organ and bone marrow function
Exclusion Criteria:
1. Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt
for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4
weeks.
2. Allergic: History of hypersensitivity to active ingredients or any other components
of the study medication; cumulative two or more allergies to contrast agents, other
drugs, or food.
3. Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency
virus (HIV), or syphilis.
4. Severe cardiac or cerebrovascular conditions, uncontrolled diabetes, hypertension
not well-managed medically (systolic >140 mmHg and/or diastolic
>90 mmHg), serious infections (active within 14 days before first
drug administration/radiotherapy), active GI ulcers, and immune dysfunction.
5. Presence of other active malignancies or history thereof, except for previously
managed non-invasive skin basal or squamous cell carcinomas with a 5-year
recurrence-free interval, cervical carcinoma in situ, and ductal carcinoma in situ
of the breast.
6. Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within
2 weeks before the initial treatment.
7. Administration of corticosteroids within the preceding 2 weeks before initial
treatment.
8. Receipt of vaccination within 2 weeks prior to initial therapy.
9. Participation in clinical trial involving drugs or biologics within 4 weeks before
the initial treatment.
10. History of major surgery within 3 months prior to initial treatment or scheduled
major surgery during the clinical trial period.
11. Prior blood donation or major hemorrhage (>450 mL) within 3
months before initial therapy, or intention to donate blood/blood components during
or within 3 months after the trial.
12. Patients with difficult venous access or intolerance to venipuncture, and those
unable to tolerate intratumoral injection.
13. Pregnant (positive pregnancy test) and lactating females.
14. Subjects planning pregnancy or gamete donation within 3 months post-consent and
unwilling to practice effective contraception.
15. Patients deemed ineligible for enrollment by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan L GCP Director
Phone:
800-555-5555
Email:
njglyygcp@163.com
Investigator:
Last name:
Baorui L Chief Physician
Email:
Principal Investigator
Start date:
November 7, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
InnoBM Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
InnoBM Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06368960
