Testing BB-1709 in patients with advanced solid tumors

A Phase I, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally Advanced/Metastatic Solid Tumors

This study is testing a new treatment called BB-1709 to see if it's safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 78 Years
• Sex: All
• Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd (Industry-sponsored)
• Drugs / interventions: immunotherapy, radiation, prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06241898 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of BB-1709 in patients with locally advanced or metastatic solid tumors. It consists of two phases: Phase Ia focuses on dose-escalation to determine the maximum tolerated dose and assess pharmacokinetics, immunogenicity, and preliminary anti-tumor activity. Phase Ib will further explore one or more recommended Phase 2 doses to continue evaluating these parameters in specific types of solid tumors.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable locally advanced or metastatic solid tumors that have progressed on or are intolerant to standard of care treatments.

Not a fit: Patients currently receiving anti-tumor therapies or those with rapidly progressing disease 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 alternatives.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise in treating solid tumors, suggesting potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent form (ICF) for the trial. Adult patients ≥ 18 years at the time of signing ICF.
2. Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors in patients who must have progressed on, be refractory to, or intolerant to prior SOC.
3. At least one measurable lesion as defined per RECIST Version 1.1.
4. Be able to provide archived or fresh tumor tissue specimens.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy ≥12 weeks.

Exclusion Criteria:

1. Receiving anti-tumor therapy (systemic anti-tumor therapies, immunotherapy, biotherapy, topic therapy, other investigational product, radiation therapy, or surgery) within 4 weeks prior to the first dose of study treatment; receiving anti-tumor small-molecule agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study treatment; receiving anti-tumor Chinese traditional medication and herbal remedies within 2 weeks prior to the first dose of study treatment.
2. Prior history of other malignancies within the previous 3 years, except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured.
3. Major surgery or significant traumatic injury within 4 weeks before the first dose of study treatment or not fully recovered from surgery; or surgery planned during the study.
4. Not recovered to baseline or CTCAE v5.0 ≤ grade 1 AEs from prior anti-cancer therapy except for alopecia, or asymptomatic and clinically not significant laboratory abnormalities.
5. Grade 2 or greater peripheral neuropathy (PN) when signing ICF, or history of grade 3 neurotoxicity or PN, or history of treatment discontinuation due to neurotoxicity or PN.
6. Active pneumonitis/interstitial lung disease (ILD), or history of radiotherapy to lung field within 12 months before the first dose of study treatment, or current lung disease with clinical symptoms(e.g., symptomatic chronic obstructive pulmonary disease or dyspnea)
7. Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases or leptomeningeal disease or carcinomatous meningitis requiring ongoing treatment for CNS metastases, including surgery or radiation therapy or steroids (\>10 mg/day of prednisone or equivalent) and antiepileptic agents.
8. Uncontrolled ascites, pleural effusion or pericardial effusion, as determined by the Investigator.
9. Active autoimmune disease, except vitiligo or cured childhood asthma/allergies that requires no intervention after adulthood, autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement, or Type I diabetes treated with stable doses of insulin can be excepted.
10. History of organ transplantation (i.e., stem cell or solid organ transplant).
11. Known history of human immunodeficiency virus (HIV) infection with the exception of patients with CD4+ T cell (CD4+) counts ≥350 cells/µL, or have not had a history of AIDS-defining opportunistic infections, or have not had a history of AIDS-defining opportunistic infections within the past 12 months , or on established antiretroviral therapy (ART) for more than four weeks and have an HIV viral load \<400 copies/mL prior to enrollment.
12. Active hepatitis B or hepatitis C infection, demonstrated by positive serology or requiring treatment. Subjects who are anti-HBs/HBcAb (+) without detectable HBV-DNA or are with undetectable HCV RNA are eligible. Subjects co-infected with hepatitis B and hepatitis C should be excluded.
13. Any other serious underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection (e.g. tuberculosis), active gastric ulcer, uncontrolled seizures, cerebrovascular incidents within 6 months prior to study treatment, gastrointestinal bleeding within 3 months prior to study treatment, severe signs and symptoms of coagulation and clotting disorders.
14. Receipt of live vaccines within 4 weeks prior to the first dose of the study drug.
15. Females who are pregnant or breastfeeding.
16. History of severe hypersensitivity or known to be allergic to protein drugs or recombinant proteins or excipients in BB-1709 drug formulation.
17. Concurrent condition that in the investigator's opinion would interfere with evaluation of the study drug or interpretation of subject safety or study results.

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Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Solid Tumor; ADC