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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Junshi Bioscience Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Taxol

    Drug

    135\~175 mg/m2, Q3W

  • Cisplatin or Carboplatin

    Drug

    Cisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5\~6, Q3W)

  • Pemetrexed

    Drug

    500 mg/m2, Q3W

  • Oxaliplatin

    Drug

    130 mg/m2, Q3W

  • Capecitabine

    Drug

    1000 mg/m2, BID, day1-14, oral, q3w

  • Bevacizumab

    Drug

    7.5 mg/kg, Q3W

  • Renvastinib

    Drug

    8mg or 20mg, QD

  • AWT020

    Drug

    q3w or q2w, i.v.

Treatment groups

214 Participants
are divided into 5 treatment groups
Group A: AWT020Experimental treatment 1 intervention
Group B: AWT020 combination with taxol and cisplatin or carboplatinExperimental treatment 3 interventions
Group C: AWT020 combination with Pemetrexed and cisplatin or carboplatinExperimental treatment 3 interventions
Group D: AWT020 combination with Oxaliplatin,Capecitabine and BevacizumabExperimental treatment 4 interventions
Group E: AWT020 combination with RenvastinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DLT rate

DLT rate

Time frame
Up to approximately 12 months from first patient in
2

AE

Safety endpoint: incidence and severity of AE, abnormal changes in clinically significant laboratory and other tests

Time frame
Up to approximately 12 months from first patient in
3

SAE

Safety endpoint: incidence and severity of SAE, abnormal changes in clinically significant laboratory and other tests

Time frame
Up to approximately 12 months from first patient in
4

MTD

Determine maximum tolerated dose

Time frame
Up to approximately 12 months from first patient in

Secondary outcomes

1

Drug concentrations

Drug concentrations in individual subjects at different time points after dosing

Time frame
Up to approximately 24 months from first patient in
2

Immunogenicity

Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples

Time frame
Up to approximately 24 months from first patient in
3

ORR

Efficacy endpoint: Objective response rate(ORR) per RECIST v1.1

Time frame
Up to approximately 32 months from first patient in
4

DOR

Efficacy endpoint: Duration of response (DOR) per RECISIT v1.1

Time frame
Up to approximately 32 months from first patient in

Other outcomes

Sponsors and contacts

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