Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT4706 in Advanced Solid Tumors

NCT05148325 | Completed Phase 1

• 1 other identifier: BAT-4706-001-CR
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors.

Conditions

Advanced Solid Tumor; Melanoma

Outcome Measures

Primary Outcomes (1)

• Explore the maximum tolerated dose (MTD)

  To evaluate the safety and tolerance of BAT4706 injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.

  21 days after first dosing

Secondary Outcomes (19)

• Cmax

  126 days after first dosing

• Tmax

  126 days after first dosing

• T1/2

  126 days after first dosing

• CL

  126 days after first dosing

• Vd

  126 days after first dosing

Study Arms (1)

Single group

EXPERIMENTAL

First Phase: dose escalation study. It was divided into six dose groups: 0.1mg/kg, 0.3mg/kg, 0.5mg/kg ,1.0mg/kg, 3.0mg/kg and 10.0mg/kg. The safety, tolerability and pharmacokinetics of bat4706 injection were explored according to the 3 + 3 dose increasing mode. It is expected that 18-36 cases will be included in the group Second Phase: dose expansion study. After the completion of dose increment, 1-2 tolerated doses were selected for extended research on melanoma (20-40 cases), so as to provide recommended doses for subsequent clinical trials

Drug: BAT4706

Interventions

BAT4706 DRUG

The administration cycle was proposed to be 3 weeks (Q3W), i.e., 21 days in a cycle, and the first 4 cycles were administered on the first day of each cycle.

Also known as: BAT 4706

Single group

Eligibility Criteria

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

You may qualify if:

• Age 18 to 75 years old (including boundary value), male or female;
• Voluntarily sign informed consent;
• Study population: advanced patients diagnosed by pathology and without effective standard treatment or standard treatment failure or standard treatment intolerance or refuse standard treatment.Patients with malignant solid tumors. (the extended study phase is mainly for patients with advanced melanoma);
• According to recist1.1 standard, there is at least one measurable tumor focus;
• ECOG score shall be 0 or 1;
• The investigator assessed the expected survival ≥ 12 weeks;
• Have sufficient organ and bone marrow functions as below:Blood routine (no blood transfusion, no hematopoietic stimulator, and no medication to correct blood count within 14 days prior to first dosing),Neutrophil absolute count (ANC) ≥1.5×109 /L, Platelet count ≥75×109/L, Hemoglobin ≥90g/L, Blood coagulation function Prothrombin time (PT) or International standardized ratio (INR) and activated partial thrombin time (APTT) ≤ 1.5×ULN, Liver function Total bilirubin (TBIL) ≤2×ULN ,Alanine aminotransferase (ALT), aspartate aminotransferase (AST) -- ≤3×ULN,Serum Creatinine ≤1.5×ULN ，renal function Serum creatinine clearance rate \& GT; 60ml/min (Cockcroft-Gault formula, see appendix)
• Female patients with fertility must have negative serum pregnancy test during screening, and agree to take effective birth control / contraception to prevent pregnancy from the study period to 6 months after the last administration. Male patients must agree to take effective contraceptive methods from the study period to 6 months after the last administration.

You may not qualify if:

• Have received experimental drug treatment or participated in clinical research of medical devices within 4 weeks before the first administration of study drugs Research;
• Received chemotherapy, radiotherapy, Biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatments within 4 weeks before the first administration of the study drug, except: 1. Nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug. 2. Oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half lives,Whichever is longer, etc.). 3. Traditional Chinese medicine/traditional Chinese patent medicines with definite anti-tumor effect, and drugs with immunomodulatory effect (including but not limited to thymosin Interferons, interleukins, etc.) within 2 weeks prior to the first use of the study drug. 4. Palliative radiotherapy within 2 weeks prior to the first use of the study drug.
• Failure of CTLA-4 monoclonal antibody treatment in the past;
• Before the first administration of the study drug, the AE (ctcae5.0) caused by previous antitumor treatment was still \> grade 1, hair loss and menstrual stimulation Except those with stable immune hypothyroidism controlled by hormone replacement therapy;
• Received interventional therapy and major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks before the first administration of the study drug;Surgery is defined here as grade 3 and 4 surgery;
• Have a history of organ transplantation;
• Central nervous system or meningeal metastasis;
• If other malignant tumors have been diagnosed in recent 5 years, or the previous malignant tumors have been cured for less than 5 years, the time of the first pathological diagnosis shall prevail Subject to. Except for radical skin basal cell carcinoma, cutaneous squamous cell carcinoma or in situ carcinoma, such as in situ breast cancer, Cervical carcinoma in situ);
• Patients with ocular melanoma;
• Patients with esophageal or gastric variceal bleeding in the past 6 months, or the investigator assessed the risk of bleeding;
• Serious cardiovascular disease occurred within 6 months before the first medication: the New York Heart Association rating (NYHA) is 2 Heart failure of grade and above, left ventricular ejection fraction (LVEF) \< 50%, unstable arrhythmia or unstable heart Colic and uncontrollable hypertension (this protocol is defined as contraction after treatment despite optimal antihypertensive treatment Blood pressure \> 150mmhg and / or diastolic blood pressure \> 100mmhg, and the investigator's evaluation is of clinical significance);
• Patients with a history of autoimmune diseases; Had splenectomy or splenic irradiation;
• Drugs with immunomodulatory effect (e.g. thymosin, interferon, interleukin) were used within 2 weeks before the first administration of the study drug Hormone) or hormone (equivalent dose \> prednisone 10mg / day);
• Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standardized anti-tuberculosis treatment and have been confirmed by researchers as cured can be included;
• Patients who have experienced severe infections within 4 weeks prior to the first medication use, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Exclude patients with active infections before the first administration;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: collaborator
• Bio-Thera Solutions: lead

Study Sites (1)

Beijing cancer hospital

Beijing, China

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jun Guo, M.D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

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: November 3, 2021
• First Posted: December 8, 2021
• Study Start: September 2, 2021
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)