Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Aosaikang Pharmaceutical Co., Ltd.

About this trial

This study is the first-in-human of ASKC202, which is an open-label, non-randomized, multicenter study with a dose escalation phase and a dose expansion phase.

Eligibility criteria

Qualifiers

Willing and able to provide signed and dated informed consent;

Aged 18 years old or more, male or female;

Part 1 (Monotherapy Dose-Escalation) and Part 3 (Monotherapy Expansion): the subjects with locally advanced or metastatic solid tumors for whom no standard therapy regimens are available currently or who are intolerable to standard therapy regimens; Part 3: the subjects with MET gene amplification or protein overexpression; Part 3 cohort 1: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.

Disqualifiers

Have previously received or are receiving any treatment for c-Mets (including all monoclonal antibodies or small molecule drugs targeted at the target, except for crizotinib);

Have received chemotherapy, hormone therapy, immunotherapy, or biological therapy such as antibody therapy within 4 weeks prior to the first dose, or traditional Chinese medicine with anti-tumor indications within 2 weeks, or small molecule targeted therapy with an interval of less than 5 half-lives; palliative radiotherapy within 7 days or extensive/therapeutic radiotherapy within 14 days prior to the first dose;

Those who still need to continue to use systemic immunosuppressants or systemic corticosteroids (≥ 10 mg of prednisone or its equivalent other corticosteroid) for 2 weeks prior to the first dose;

Patients who have used strong inhibitors or strong inducers of CYP3A within 2 weeks prior to the first administration, or who need to continue treatment with these drugs during the study period;

Trial design

Treatments tested in this trial

  • ASKC202
  • ASK120067

Treatment groups

150 Participants
are divided into 2 treatment groups