Advanced Solid TumorsPhase 1BM201-1001NCT06368960
BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing Radiotherapy and BM201 injection in people with Advanced Solid Tumors, run by InnoBM Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Radiotherapy and BM201 injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.
- ECOG performance status score of 0-2 point;
- Expected survival of ≥3 months.
- At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.
- 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.
- Adequate organ and bone marrow function
Who cannot join
- Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.
- 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.
- Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.
- 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.
- 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.
- Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within 2 weeks before the initial treatment.
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- Administration of corticosteroids within the preceding 2 weeks before initial treatment.
- Receipt of vaccination within 2 weeks prior to initial therapy.
- Participation in clinical trial involving drugs or biologics within 4 weeks before the initial treatment.
- History of major surgery within 3 months prior to initial treatment or scheduled major surgery during the clinical trial period.
- 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.
- Patients with difficult venous access or intolerance to venipuncture, and those unable to tolerate intratumoral injection.
- Pregnant (positive pregnancy test) and lactating females.
- Subjects planning pregnancy or gamete donation within 3 months post-consent and unwilling to practice effective contraception.
- Patients deemed ineligible for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Juan L GCP Director, 800-555-5555, njglyygcp@163.com
Baorui L Chief Physician
About this study
Official title: The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- Radiotherapy, BM201 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called RT
Radiation： Hypofractionated radiotherapy
BM201 injectionDrug
Also called BM201
BM201 injection：Dose escalation：24mg to 240mg
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Radiation：Hypofractionated radiotherapy Receives: Radiation: Radiotherapy |
| BM201 injection combined with radiotherapy | Experimental | BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy Receives: Radiation: Radiotherapy; Drug: BM201 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT and MTD
Dose limiting toxicity and maximum tolerated dose
Measured: Up to 14 days after the initial treatment
Pharmacokinetic (PK) parameters
Maximum plasma concentration(Cmax) of the drug after administration
Measured: From pre-dose to 96 hrs post-dose
Number of patients with adverse events (AEs)
Number of patients with treatment-related adverse events (AEs)
Measured: From the first treatment to 42 days after the last treatment.
Secondary outcomes (4)
ORR
Objective Response Rate
Measured: Up to 42 days after the last treatment
Peripheral blood cytokine profiling in study participants.
To investigate the change of peripheral blood cytokine level in subjects after the treatment.
Measured: From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.
The variation in peripheral blood tumor biomarker concentrations.
The variation of concentrations of AFP，NSE，CEA ；
Measured: Up to 42 days after the last treatment
Other exploring outcomes
The variation of tumor tissue biomarker expression levels
Measured: Up to 14 days after the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start7 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoBM Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baorui L Chief Physician, PH.D, Principal investigator, Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368960
- Sponsor's protocol ID
- BM201-1001
- Other IDs
- CTR20223162
- Acronym
- BM201-1001
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT06368960
- Acronym / sponsor ID
- BM201-1001 / BM201-1001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- InnoBM Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyRadiation：Hypofractionated radiotherapy |
| BM201 injection combined with radiotherapy | Experimental | Radiation: Radiotherapy, Drug: BM201 injectionBM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.
- ECOG performance status score of 0-2 point;
- Expected survival of ≥3 months.
- At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.
- 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.
Key exclusion criteria (15 listed)
- Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.
- 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.
- Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: RTRadiation： Hypofractionated radiotherapy | Radiation | BM201 injection combined with radiotherapy, Radiotherapy |
| BM201 injectionAlso: BM201BM201 injection：Dose escalation：24mg to 240mg | Drug | BM201 injection combined with radiotherapy |
Primary outcome
DLT and MTD
Time frame: Up to 14 days after the initial treatment
Dose limiting toxicity and maximum tolerated dose
Pharmacokinetic (PK) parameters
Time frame: From pre-dose to 96 hrs post-dose
Maximum plasma concentration(Cmax) of the drug after administration
Number of patients with adverse events (AEs)
Time frame: From the first treatment to 42 days after the last treatment.
Number of patients with treatment-related adverse events (AEs)
4 secondary outcomes
ORR
Time frame: Up to 42 days after the last treatment
Peripheral blood cytokine profiling in study participants.
Time frame: From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.
The variation in peripheral blood tumor biomarker concentrations.
Time frame: Up to 42 days after the last treatment
Other exploring outcomes
Time frame: Up to 14 days after the initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baorui L Chief Physician, PH.D principal investigator
Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiotherapy and BM201 injection in people with Advanced Solid Tumors, run by InnoBM Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuntao G PM (86+0512 6938 6599, ctgong@innobm.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT and MTD (time frame: Up to 14 days after the initial treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.