A Study to Evaluate the Safety and Efficacy of ALMB-0168 in Patients With Osteosarcoma

NCT04886765 | Unknown Phase 1

• 1 other identifier: ALMB-0168-CN-101
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I / II, multi-center, single-arm, open-label study to evaluate the safety and efficacy of ALMB-0168 in patients with osteosarcoma whose prior standard treatment have failed.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0). Incidence of adverse events will be assessed in both PART I and PART II.

  From enrollment to 28 days after the last dose in each part study.

• Dose-Limited Toxicities (DLT)

  DLTs were assessed according to NCI-CTCAE v.5.0 during the first cycle

  Up to 21 days in Cycle 1

• 6-Month Progression-free Survival Rate (6m-PFSR)

  6m-PFSR is defined as the percentage of patients who will be alive and without PD at 6 months from the randomization date. 6m-PFSR will be assessed only in PART II.

  From enrollment to 6 month after the first dose of the last patient in PART II

Secondary Outcomes (20)

• Maximum concentration (Cmax) of ALMB-0168

  From enrollment to 4 weeks after the last dose of the last patient

• Time to maximum concentration (Tmax) of ALMB-0168

  From enrollment to 4 weeks after the last dose of the last patient

• Minimum concentration(Cmin) of ALMB-0168

  From enrollment to 4 weeks after the last dose of the last patient

• The area under the curve (AUC) of ALMB-0168

  From enrollment to 4 weeks after the last dose of the last patient

• Half-life (t1/2) of ALMB-0168

  From enrollment to 4 weeks after the last dose of the last patient

Study Arms (1)

ALMB-0168

EXPERIMENTAL

Dose Escalation Cohort ：The accelerated titration and traditional "3+3" design will be used in the dose-escalation phase. Seven dose cohorts will be evaluated. ALMB-0168 will be administered intravenously once every 3 weeks until either the disease progresses or intolerable toxicity occurs. Dose Expansion Cohort: Based on the results of Part I, 1-3 dose expansion cohorts will be started to further evaluate the safety and efficacy of ALMB-0168.

Drug: ALMB-0168

Interventions

ALMB-0168 DRUG

ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs.

ALMB-0168

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed osteosarcoma;
• Patients will be enrolled according to different stages:
• Part I: Patients with osteosarcoma whose prior standard treatment have failed.;
• Part II: Patients with high-grade osteosarcoma whose prior standard treatment have failed.; Standard treatment failure is defined as the progression on or within 6 months after the first-line chemotherapy (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); For patients with disease progression more than 6 months after the chemotherapy, the risk-benefit assessment should be conducted by the investigators;
• years of age or older, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
• Either measurable or non-measurable disease per RECIST v1.1. Non-measurable disease should be assessable by conventional imaging techniques including isotope bone scans, CT or MRI scans. Patients in part II stage must have at least one measurable lesion confirmed by CT or MRI at baseline.
• Adequate major system function defined as:
• Bone marrow reserve: Absolute neutrophil count (ANC) ≥1.5 x109/L; Platelet count ≥ 75 x 109/L; Hemoglobin ≥ 90 g/L (not receiving blood transfusion within 14 days before the first administration);
• Hepatic function: Total bilirubin ≤1.5 x upper limit of normal (ULN), Transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)) ≤ 3 x ULN (\<5 x ULN for liver metastases);
• Renal function: Normal serum creatinine ≤1.5 mg/dL (133 μmol/L) OR calculated creatinine clearance ≥50 mL/min. (Cockcroft - Gault formula);
• Coagulation: Adequate coagulation parameters defined as International Normalization Ratio (INR) ≤2.
• Female patients of childbearing potential must have negative results of serum pregnancy test within 7 days before the first dose. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 3 months following the last dose. Male patients must also refrain from donating sperm during their participation in the study;
• Life expectancy ≥3 months;
• Ability to understand the entire process of this study, voluntarily participate and sign a written informed consent form.

You may not qualify if:

• Any recent anti-tumour therapy ≤ 28 days before the first dose or residual more than Grade 1 chemotherapy-related side effects per NCI CTCAE v5.0, with the exception of alopecia.
• Have participated in the other clinical trial and received the investigational drug treatment within 4 weeks before the first dose of study drug;
• Wide-field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy;
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement;
• Brain metastases, leptomeningeal metastases or, spinal cord compression or central nervous system (CNS) injuries/abnormalities;
• Pregnant women. Breastfeeding women should stop breastfeeding before signing the informed consent;
• Any of the following cardiac diseases currently or within the last 6 months:
• Left ventricular ejection fraction (LVEF) \<45% as determined by echocardiogram (ECHO);
• The corrected QT interval (Fridericia formula) interval (QTcF) \> 470 msec for females and \> 450 msec for men in electrocardiogram (ECG) at screening;
• Unstable angina pectoris;
• Heart failure (New York Heart Association (NYHA) \>2 grade);
• Acute myocardial infarction;
• Uncontrolled arrhythmia;
• Acute coronary syndromes;
• Stent placement;

Sponsors & Collaborators

• AlaMab Therapeutics (Shanghai) Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Jingnan Shen, Doctor

  the first affiliated Hospital, Sun Yat-sen Unibersity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojing Lee, Master

CONTACT

+86-028-63925025; lixiaojing@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2024
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share