BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Radiation: Radiotherapy; Drug: BM201 injection

• Registration Number: NCT06368960
• Lead Sponsor: InnoBM Pharmaceuticals Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2022-11-07
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	Radiation：Hypofractionated radiotherapy
BM201 injection combined with radiotherapy	BM201 injection	BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy
BM201 injection combined with radiotherapy	Radiotherapy	BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy

Primary Outcome Measures

Name	Time	Method
DLT and MTD	Up to 14 days after the initial treatment	Dose limiting toxicity and maximum tolerated dose
Pharmacokinetic (PK) parameters	From pre-dose to 96 hrs post-dose	Maximum plasma concentration(Cmax) of the drug after administration
Number of patients with adverse events (AEs)	From the first treatment to 42 days after the last treatment.	Number of patients with treatment-related adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
ORR	Up to 42 days after the last treatment	Objective Response Rate
Peripheral blood cytokine profiling in study participants.	From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.	To investigate the change of peripheral blood cytokine level in subjects after the treatment.
The variation in peripheral blood tumor biomarker concentrations.	Up to 42 days after the last treatment	The variation of concentrations of AFP，NSE，CEA ；
Other exploring outcomes	Up to 14 days after the initial treatment	The variation of tumor tissue biomarker expression levels

Trial Locations

Locations (1)

Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China