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

RecruitingPhase 1Ages 18 Years - anyAllShanghai Junshi Bioscience Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \> Adjuvant and neoadjuvant therapy that progresses within 6 months); Mucosal melanoma does not require prior PD-(L)1 inhibitor therapy. 3. CRC: colorectal adenocarcinoma or rectal adenocarcinoma with histologically confirmed PD-L1 composite positive score \[CPS\] ≥1, failure or intolerance of standard treatment, or no standard treatment options. PD-L1 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study). 4. RCC: Histologically confirmed metastatic or unresectable clear cell type of RCC with disease progression after previous treatment with targeted anti-angiogenesis therapy and PD-(L)1 inhibitors. 5. Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment or have no standard treatment options. * Combination phase: 1. NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has not 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 carrying EGFR or ALK mutations were allowed to progress on kinase inhibitor therapy with a previous ≤1 line. 2. CRC: Histologically confirmed PD-L1 CPS≥1 colorectal adenocarcinoma or rectal adenocarcinoma without prior systemic therapy (except after the last dose of medication \> Adjuvant therapy that progresses within 6 months); In patients with MSI-H/dMMR, previous treatment with PD-(L)1 inhibitors is permitted. PD-L1 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study). 3. RCC: Histologically confirmed metastatic or unresectable clear cell RCC with disease progression after previous treatment with anti-angiogenesis targeted therapy and PD-(L)1 inhibitors. 4. Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \> Adjuvant therapy that progresses within 6 months). 5. HCC: Histologically/cytologically confirmed or cirrhotic patients meet the clinical diagnostic criteria for HCC in AASLD, are identified as having stage B (intermediate) or stage C (advanced) BCLC HCC and are not candidates for radical surgery and/or local therapy, and have previously received PD-(L)1 inhibitors and anti-angiogenic targeted therapy progression. 6. Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment, or have no standard treatment options. 3. ECOG score is 0 or 1; 4. Expected survival ≥12 weeks; 5. Have at least one measurable lesion according to RECIST 1.1 evaluation criteria; 6. Good organ function; 7. Fertile female or male subjects must agree to be childfree during the study period until 6 months after the end of the last dose and voluntarily take highly effective contraception with their partner; The serum pregnancy test for WOCBP must be negative within 7 days prior to the first dose and must be non-lactation (specific contraceptive methods and WOCBP definitions are set out in section 10.3); 8. Patients participate voluntarily, give full informed consent, sign written informed consent, and have good compliance. Exclusion Criteria: 1. Received the following drugs or treatments before the first dose: 1. received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose, or received oral fluorouracil, small molecule targeted drugs or Chinese medicines with anti-tumor indications within 14 days before the first dose; 2. Major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for local bone/brain lesions allowed within 14 days before the first dose), coarse needle puncture biopsy or other minor surgery within 7 days before the start of study therapy, excluding placement of vascular infusion devices; 3. In combination therapy, patients who have been systematically treated with corticosteroids (\> 10 mg prednisone per day or equivalent) or other immunosuppressants for more than 1 week within 2 weeks prior to initial administration are allowed to be treated with inhaled or topical steroids or ≤10 mg/ day systemic prednisone and equivalent doses of similar drugs; 2. There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in
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What it tests

  • Taxol
  • Cisplatin or Carboplatin
  • Pemetrexed
  • Oxaliplatin
  • Capecitabine
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Where

13 sites
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
Hubei Cancer Hospital
Wuhan, China
Hunan Cancer Hospital
Changsha, China
First Affiliated Hospital of Nanchang University
Nanchang, China
The First Hospital of Jilin University
Changchun, China

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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