BM201 combined with radiotherapy for advanced solid tumors

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 study is testing if a new injection called BM201, when combined with radiation therapy, can be safe and helpful for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: InnoBM Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06368960 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety and tolerability of BM201 injection when used alongside radiotherapy in patients with advanced solid tumors that are either unresectable or have not responded to standard treatments. The study is non-randomized and open-label, focusing on patients with confirmed metastatic solid tumors who have either failed standard therapy or are ineligible for it. Participants will receive BM201 injections and radiotherapy, with assessments of pharmacokinetics and preliminary efficacy. The trial aims to gather data on the treatment's safety profile and potential effectiveness.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable advanced or metastatic solid tumors who have either failed standard therapy or are ineligible for it.

Not a fit: Patients with active brain metastasis or those with severe allergies to the study medication components may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with radiotherapy have shown promise in other contexts.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Baorui L Chief Physician, PH.D — Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
• Study coordinator: Chuntao G PM

Conditions Advanced Solid Tumors