NCT06438783TerminatedPhase 1
A Multicenter, Open-label, Multi-cohort Phase Ib Trial Evaluating the Efficacy and Safety of TQB2928 Injection Combined With Anlotinib Hydrochloride Capsule in Relapsed/Metastatic Osteosarcoma and Other Relapsed/Metastatic Solid Tumors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.5 sites in 1 country20 target enrollmentStarted: February 15, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 20
- Locations
- 5
- Primary Endpoint
- Cohort 1: Progression-Free Survival (PFS) of 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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;
- •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).
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).
Arms & Interventions
1800mg of TQB2928 injection+Anlotinib
Experimental
21 days as a treatment cycle.
Intervention: 1800mg of TQB2928 injection+Anlotinib (Drug)
1200mg of TQB2928 injection +Anlotinib
Experimental
21 days as a treatment cycle.
Intervention: 1200mg of TQB2928 injection+Anlotinib (Drug)
Outcomes
Primary Outcomes
Cohort 1: Progression-Free Survival (PFS) of 6 months
Time Frame: 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)
Time Frame: 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 Outcomes
- Disease control rate (DCR) of Cohort 1 and Cohort 2(Up to 6 weeks)
- Cohort 2: Progression-Free Survival (PFS) of 6 months(Up to 6 months)
- Overall survival (OS) of Cohort 1 and Cohort 2(Baseline up to 96 weeks)
- Adverse event rate of Cohort 1 and Cohort 2(Baseline up to 96 weeks)
- Cohort 1: Progression-Free Survival (PFS) of 4 months(Up to 4 months)
- Cohort 1: Overall response rate (ORR)(Baseline up to 96 weeks)
- Progression-Free Survival (PFS) of Cohort 1 and Cohort 2(Up to 96 weeks)
- 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))
- Duration of response(DOR) of Cohort 1 and Cohort 2(Baseline up to 96 weeks)
Investigators
Study Sites (5)
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