Clinical trial NCT06438783: TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Osteosarcoma
Other Solid Tumors
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

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).

Primary outcomes:
measure: Cohort 1: Progression-Free Survival (PFS) of 6 months
timeFrame: Up to 6 months
measure: Cohort 2: Overall response rate (ORR)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Cohort 1: Progression-Free Survival (PFS) of 4 months
timeFrame: Up to 4 months
measure: Cohort 1: Overall response rate (ORR)
timeFrame: Baseline up to 96 weeks
measure: Cohort 2: Progression-Free Survival (PFS) of 6 months
timeFrame: Up to 6 months
measure: Progression-Free Survival (PFS) of Cohort 1 and Cohort 2
timeFrame: Up to 96 weeks
measure: Disease control rate (DCR) of Cohort 1 and Cohort 2
timeFrame: Up to 6 weeks
measure: Duration of response(DOR) of Cohort 1 and Cohort 2
timeFrame: Baseline up to 96 weeks
measure: Overall survival (OS) of Cohort 1 and Cohort 2
timeFrame: Baseline up to 96 weeks
measure: Adverse event rate of Cohort 1 and Cohort 2
timeFrame: Baseline up to 96 weeks
measure: Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb )
timeFrame: 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)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing jishuitan hospital
state: Beijing
city: Beijing
country: China
facility: Pekjing university people's hospital
state: Beijing
city: Beijing
country: China
facility: Beijing cancer hospital
state: Beijing
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Tianjin
country: China
facility: Tianjin medical university cancer institute&hospital
state: Tianjin
Study officials:
References: