Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure

NCT06935409 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HS-20093-304
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure.

Conditions

Osteosarcoma

Keywords

phase 3; osteosarcoma; HS-20093

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRC as per RECIST 1.1 criteria

  PFS is defined as the time interval from the randomization to disease progression as per ICR assessment or death due to any cause.

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years.

Secondary Outcomes (8)

• ORR assessed by IRC as per RECIST 1.1 criteria

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

• DCR assessed by IRC as per RECIST 1.1 criteria

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

• DoR assessed by IRC as per RECIST 1.1 criteria

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

• ORR assessed by the investigator as per RECIST 1.1 criteria

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

• DCR assessed by the investigator as per RECIST 1.1 criteria

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 5 years

Study Arms (2)

HS-20093

EXPERIMENTAL

Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.

Drug: HS-20093

Gemcitabine combined with docetaxel

ACTIVE COMPARATOR

Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.

Drug: Gemcitabine combined with docetaxel

Interventions

HS-20093 DRUG

Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.

HS-20093

Gemcitabine combined with docetaxel DRUG

Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.

Gemcitabine combined with docetaxel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females over 12 years old (≥ 12 years).
• Pathologically confirmed osteosarcoma (key IHC/tumor cell phenotyping results required for a definitive diagnosis must be provided).
• The study participants should have at least 1 target lesion based on RECIST 1.1.
• An ECOG PS of 0 to 1, with no exacerbation within two weeks prior to first dosing.
• A minimum expected survival of greater than 12 weeks.
• Female study participants of childbearing potential must be willing to use appropriate contraceptive measures and refrain from breastfeeding from the signing of informed consent to six months after the last dosing or the end of treatment (whichever occurs later); male study participants must be willing to use barrier contraceptive measures (i.e., condoms) from the signing of informed consent to six months after the last dosing or the end of treatment (whichever occurs later).
• Female study participants must provide negative blood or urine pregnancy test results within seven days before the first dosing, or meet one of the following criteria to prove there is no risk of pregnancy:
• Voluntary participation in this clinical trial, and signing and dating of the written ICF approved by the IRB/IEC in accordance with regulatory, local, and institutional guidelines.

You may not qualify if:

• Prior or ongoing therapies as follows:
• Prior or current use of treatments targeting B7-H3
• Prior or current use of treatments with topoisomerase I inhibitors, including antibody-drug conjugates that are effectively loaded with topoisomerase I inhibitors
• Prior or current use of systemic anti-tumor therapy with gemcitabine in combination with docetaxel;
• Use of cytotoxic chemotherapy drugs, experimental drugs, traditional Chinese medicines for anti-tumor indicationsor other anti-tumor drugs within 14 days prior to randomization; or requiring continued use of such drug therapies during the study;
• Use of macromolecular anti-tumor drug therapy within 28 days prior to randomization;
• Presence of residual grade ≥ 2 toxicities by Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous treatments.
• History of other primary solid tumors.
• Inadequate bone marrow reserve or liver and kidney organ function, which meets any of the following laboratory limits:
• Serious, uncontrolled or active cardiovascular diseases.
• Severe or poorly controlled diabetes, including: ① Diabetic ketoacidosis or hyperglycemia and hyperosmolarity within 6 months prior to randomization; or ② other severe or poorly controlled diabetes conditions as determined by the investigator.
• Severe or poorly controlled hypertension, including: history of prior hypertensive crisis or hypertensive encephalopathy; adjustment of antihypertensive drug therapy within two weeks prior to randomization due to poor blood pressure control; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg during the screening period.
• Have clinically significant hemorrhage symptoms or significant hemorrhagic diathesis within 1 month before randomization.
• Serious arteriovenous thrombotic events within 3 months before randomization, such as deep vein thrombosis, pulmonary embolism, etc. .
• Severe infection within four weeks prior to randomization, including but not limited to complications of infection, bacteremia, or severe pneumonia requiring intravenous antibiotic therapy for ≥ 2 weeks; or uncontrollable active infection during the screening period. Study participants who are receiving or have received prophylactic antibiotics may be enrolled.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (2)

Beijing Jishuitan Hospital affiliated to Capital Medical University

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 20, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (2)