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Recruiting Phase 1 NCT06839105

A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

Trial Parameters

Condition Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor
Sponsor Shanghai Junshi Bioscience Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 214
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-21
Completion 2028-04-30
Interventions
TaxolCisplatin or CarboplatinPemetrexed

Brief Summary

The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies

Eligibility Criteria

Inclusion Criteria: 1. Both male and female subjects who are at least 18 years old at the time of signing the consent form; 2. Inclusion of patients with advanced malignancies confirmed histologically or cytologically and meeting the following requirements: * Single-agent dose escalation and expansion phase to include patients with advanced malignant tumors who have failed or are intolerant of standard treatment, or have no standard treatment options; * Therapeutic effect expansion stage of single drug: 1. NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has progressed after prior treatment with PD-(L)1 antibody and platinum-containing chemotherapy (except after the last dose \> Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors. 2. Melanoma: histologically unresectable stage III or

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