Evaluating a new treatment for advanced solid tumors

An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1106 in Participants With Advanced Solid Tumors

This study is testing a new treatment called BA1106 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Boan Biotechnology Co., Ltd (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05650242 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1 trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BA1106, a human anti-CD25 monoclonal antibody, in patients with advanced solid tumors. The study consists of two parts: Part A focuses on dose escalation using the BOIN method, while Part B involves dose expansion with selected dosing regimens and indications. Participants will receive BA1106 once every 2 or 3 weeks, depending on the part of the study they are in.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors that have progressed on all standard therapies or are intolerant to them.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment 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 exhausted standard therapies.

How similar studies have performed: While this is a first-in-human study, similar monoclonal antibody approaches have shown promise in treating solid tumors in previous trials.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
3. At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1;
4. Able to provide the most recent archival tumor tissue samples (negotiable);
5. Life expectancy \>=12 weeks;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. Adequate major organ function;
8. Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods;
9. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria:

1. Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention;
2. Participants with any infection requiring intravenous therapy, or any other uncontrolled active infection, within 2 weeks prior to informed consent;
3. Participants with symptomatic radiation pneumonia, radiation esophagitis, radiation colitis; extensive interstitial lung disease of both lungs, chronic obstructive pulmonary disease requiring bronchodilators or regular hormonal therapy; unhealed peptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizing enteritis, gastrointestinal obstruction (except those who are relieved with treatment and have no safety risk as assessed by the investigator), gastrointestinal bleeding tendency or high risk of perforation, pancreatitis requiring treatment; arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8 weeks prior to C1D1;
4. Participants with active autoimmune disease or the risk of recurrence;
5. Participants with major cardiocerebral vascular disease;
6. Participants with body cavity effusion requiring local treatment or determined as poorly controlled by the investigator;
7. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DIHS (drug-induced hypersensitivity syndrome);
8. Participants with diseases affecting intravenous injection and venous blood collection;
9. Prior use of any anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, traditional Chinese medicine, etc.) within 4 weeks, or non-antitumor traditional Chinese medicine within 2 weeks, prior to C1D1;
10. Prior use of drugs targeting IL-2 receptors;
11. History of being receipt of any organ transplantation or allogeneic stem-cell transplantation;
12. Risk of gastrointestinal ulcers or bleeding as assessed by the investigator;
13. Prior treatment with systemic immunosuppression excluding nasal/inhaled corticosteroids or physiological dosed systemic corticosteroids, within 2 weeks prior to C1D1;
14. Prior treatment with cytokine, blood transfusion, or blood products within 4 weeks prior to C1D1;
15. Participants with major surgical procedure or significant traumatic injury, within 4 weeks prior to C1D1; or with wound healing complications before enrolment;
16. Vaccination with live vaccines within 4 weeks prior to informed consent;
17. Known hypersensitivity to any of the components of BA1106;
18. Participants with grade 2 or higher toxicities from any previous therapies \[except for cases of alopecia and peripheral sensory neuropathy (both grade 2), which are allowed\];
19. Positive for Hepatitis B and C, or positive HIV test at screening;
20. History of drug abuse, drug addiction, or alcoholism;
21. Pregnancy, lactation, or breastfeeding;
22. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Where this trial is running

Beijing, Beijing

• Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Lin Shen

Conditions: Solid Tumors, BA1106, First in human study, safety