Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLC5513 IV infusion, QL1706, IV infusion, platinum, IV infusion.
- Who it may be relevant to
- Registry conditions: Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
Overview
The goal of this Phase Ib/II interventional study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of QLC5513 combined with QL1706± platinum in the treatment of patients with advanced or metastatic malignant solid tumors. This study is divided into two phases: Phase Ib is the combined dose escalation phase, where dose escalation of QLC5513 combined with QL1706± platinum is conducted and RP2D is explored; In the Phase II tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLC5513 combined with QL1706± platinum-based treatment in patients with advanced or metastatic malignant solid tumors.
Interventions
- Drug QLC5513 IV infusion
Participants will receive QLC5513 16 mg/kg intravenously on Days1, Day 8 and Day 15 of 28-day cycles. - Biological QL1706, IV infusion
QL1706 5mg/kg intravenously on Day 1 of 21-day. - Drug platinum, IV infusion
Cisplatin: 75 mg/m ² or carboplatin：AUC=5 mg/mL/min on Day 1 of 21-day.
Primary outcome measures
- The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLC5513 combined with QL1706± platinum in patients with advanced solid tumors. [Time frame: up to 12 months]
- Number of participants who experience one or more adverse events(AEs). [Time frame: up to 48 months]
- Objective Response Rate [Time frame: up to 36 months]
Secondary outcome measures (3)
- DOR [Time frame: up to 48 months]
- PFS [Time frame: up to 48 months]
- OS [Time frame: up to 60 months]
Eligibility criteria
Inclusion criteria
- Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.
- Has adequate organ function.
- The expected survival period is ≥3 months.
- Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.
- According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.
Exclusion criteria
- Prior treatment with TROP2-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.
- There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.
- Active, uncontrolled bacterial, fungal or viral infections.
- Radiotherapy with more than 25% of the bone marrow exposed within 4 weeks prior to the first use of the investigational drug; Local radiotherapy (excluding brain radiotherapy) was performed within two weeks before the first use of the investigational drug.
- Subjects with a history of a second malignant tumor other than the target indication within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).
- Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2. History of irAEs from prior immune checkpoint inhibitor treatment that required permanent discontinuation of the immune checkpoint inhibitor.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07272590 · QLC5513-201