TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors

Phase 1

Recruiting

• Conditions: Other Solid Tumors; Osteosarcoma
• Interventions: Drug: 1800mg of TQB2928 injection+Anlotinib; Drug: 1200mg of TQB2928 injection+Anlotinib

• Registration Number: NCT06438783
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Brief Summary

This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2024-02-15
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-10
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment;

• The requirements for front-line treatment received by subjects are as follows:

  1. Subjects with osteosarcoma have failed at least first-line chemotherapy and are not suitable for re-receiving first-line chemotherapy ,or progression within 6 months of the end of first-line therapy;
  2. Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have received at least first-line chemotherapy failure for recurrent/metastatic sites or relapse during postoperative adjuvant chemotherapy or within 6 months after treatment(considered first-line treatment failure).

Read More

Exclusion Criteria

• History of hemolytic anemia from any cause (including Evans syndrome) within 3 months prior to first dosing;
• Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib;
• Previous antibody or fusion protein or small molecule drug targeting CD47 or Signal-regulatory protein α (SIRRP-α).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1800mg of TQB2928 injection+Anlotinib	1800mg of TQB2928 injection+Anlotinib	21 days as a treatment cycle.
1200mg of TQB2928 injection +Anlotinib	1200mg of TQB2928 injection+Anlotinib	21 days as a treatment cycle.

Primary Outcome Measures

Name	Time	Method
Cohort 1: Progression-Free Survival (PFS) of 6 months	Up to 6 months	Cohort 1: Kaplan-Meier method was used to plot the survival curve, in which the cumulative survival rate and 95% confidence interval corresponding to the progression-free survival time of 6 months were obtained.
Cohort 2: Overall response rate (ORR)	Up to 6 months	Cohort 2: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR) of Cohort 1 and Cohort 2	Up to 6 weeks	The percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by the investigator based on RECIST 1.1.
Cohort 2: Progression-Free Survival (PFS) of 6 months	Up to 6 months	Cohort 2: Kaplan-Meier method was used to plot the survival curve with the corresponding cumulative survival rate and 95% confidence interval (95% CI) when the progression-free survival time was 6 months. The overall population and 2 dose groups were counted separately (including participants in the safe introduction period and the extended period).
Overall survival (OS) of Cohort 1 and Cohort 2	Baseline up to 96 weeks	From randomization to the time of death from any cause.
Adverse event rate of Cohort 1 and Cohort 2	Baseline up to 96 weeks	Incidence and severity of adverse events (AES) and serious adverse events (SAEs), abnormal laboratory test indicators and treatment-related adverse events (TEAEs).
Cohort 1: Progression-Free Survival (PFS) of 4 months	Up to 4 months	Cohort 1: Survival curve was plotted using Kaplan-Meier method. In the curve, the corresponding cumulative survival rate and 95% confidence interval for progression-free survival of 4 months were obtained.
Cohort 1: Overall response rate (ORR)	Baseline up to 96 weeks	Cohort 1: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.
Progression-Free Survival (PFS) of Cohort 1 and Cohort 2	Up to 96 weeks	The time between medication or random initiation and objective progression of disease or death from any cause, whichever comes first.
Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb )	30 minutes before administration on day 1 of cycles 1, 2, 4 and 8 (each cycle is 21 days), day 90 after the last administration (±7 days)	The positive rates of immunogenicity (ADA and NAb) in subjects were summarized and descriptive statistical analysis was performed.
Duration of response(DOR) of Cohort 1 and Cohort 2	Baseline up to 96 weeks	For subjects whose optimal response was complete response (CR) or partial response (PR), defined as from the date when tumor response was first documented to the date when disease progression was first documented or the date of death from any cause, whichever came first.

Trial Locations

Locations (5)

Beijing jishuitan hospital; 🇨🇳 Beijing, Beijing, China

Pekjing university people's hospital; 🇨🇳 Beijing, Beijing, China

Hunan cancer hospital; 🇨🇳 Changsha, Hunan, China

Tianjin medical university cancer institute&hospital; 🇨🇳 Tianjin, Tianjin, China

Beijing cancer hospital; 🇨🇳 Beijing, Beijing, China