A Study of SI-B036 in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors

NCT07763639 | Not Yet Recruiting Phase 1

• 1 other identifier: SI-B036-105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 Bispecific Antibody Injection in patients with locally advanced or metastatic head and neck tumors and other solid tumors.

Conditions

Head and Neck Tumors; Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Phase Ia: Dose limiting toxicity (DLT)

  DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

  Up to 21 days after the first dose

• Phase Ia: Maximum tolerated dose (MTD)

  MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle.

  Up to 21 days after the first dose

• Phase Ib: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B036.

  Up to approximately 24 months

Secondary Outcomes (12)

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

• T1/2

  Up to approximately 24 months

• AUC0-t

  Up to approximately 24 months

Study Arms (1)

SI-B036

EXPERIMENTAL

Participants receive SI-B036 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: SI-B036

Interventions

SI-B036 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

SI-B036

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
• No gender restriction;
• Age: ≥18 years and ≤75 years;
• Life expectancy ≥3 months;
• Locally advanced or metastatic head and neck tumors and other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the protocol requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be lactating. All enrolled patients (regardless of gender) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;
• Participants must be capable of and willing to comply with the study visits, treatment plans, laboratory tests, and other study-related procedures as specified in the protocol.

You may not qualify if:

• Received chemotherapy, biotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
• Received immunosuppressive medications within 2 weeks prior to the first dose;
• History of severe cardiac or cerebrovascular disease;
• Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Active autoimmune diseases and inflammatory diseases;
• History of ≥ Grade 3 toxicity related to anti-angiogenic therapy when previously receiving such treatment;
• Diagnosis of another solid malignancy within 5 years prior to the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Uncontrolled hypertension;
• Diabetes mellitus with poor glycemic control;
• History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;
• Concurrent pulmonary disease resulting in severe impairment of respiratory function;
• Active central nervous system (CNS) metastases;
• History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

CN (2)