About this trial
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
This trial does not accept healthy volunteersQualifiers
Both male and female subjects who are at least 18 years old at the time of signing the consent form;
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;
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.
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.
Disqualifiers
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;
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;
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;
There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in the past, imaging examination within 4 weeks before the first medication indicates stable brain metastases without aggravation or new neurological symptoms, hormone therapy has been discontinued 2 weeks before the first medication, and screening is allowed; For meningeal and brainstem metastases, screening is not allowed regardless of treatment.
Trial design
Sequential
Treatments tested in this trial
Taxol
Drug135\~175 mg/m2, Q3W
Cisplatin or Carboplatin
DrugCisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5\~6, Q3W)
Pemetrexed
Drug500 mg/m2, Q3W
Oxaliplatin
Drug130 mg/m2, Q3W
Capecitabine
Drug1000 mg/m2, BID, day1-14, oral, q3w
Bevacizumab
Drug7.5 mg/kg, Q3W
Renvastinib
Drug8mg or 20mg, QD
AWT020
Drugq3w or q2w, i.v.
Treatment groups
Trial outcomes
Primary outcomes
DLT rate
DLT rate
AE
Safety endpoint: incidence and severity of AE, abnormal changes in clinically significant laboratory and other tests
SAE
Safety endpoint: incidence and severity of SAE, abnormal changes in clinically significant laboratory and other tests
MTD
Determine maximum tolerated dose
Secondary outcomes
Drug concentrations
Drug concentrations in individual subjects at different time points after dosing
Immunogenicity
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples
ORR
Efficacy endpoint: Objective response rate(ORR) per RECIST v1.1
DOR
Efficacy endpoint: Duration of response (DOR) per RECISIT v1.1
Sponsors and contacts
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