HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHangzhou Hanx Biopharmaceuticals, Ltd.

About this trial

Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma

Eligibility criteria

Qualifiers

Voluntarily participate in the trial and sign the informed consent form;

male or female, age at 18 to 70 years (including borderline value) ;

expected survival ≥ 12 weeks;

ECOG score 0-1;

Disqualifiers

Histological or pathological diagnosis of carcinoma of the jugular abdomen;

Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patients with cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRK gene fusion, RET gene fusion mutation, FGFR2 gene fusion, IDH1 gene mutation, and KRAS mutation

Subjects with symptomatic brain metastases, meningeal metastases, or spinal cord compression, except for the following: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no need for corticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeks as confirmed by imaging tests);

have had a malignancy other than the study disease (biliary malignancy, malignant melanoma) within 5 years prior to signing the ICF, except for malignancies with negligible risk of metastasis or death and/or those that have received curative treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);

Trial design

Treatments tested in this trial

  • HX009+IN10018

Treatment groups

124 Participants
are divided into 1 treatment group