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

ConditionsBiliary Tract CancerMelanoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HX009+IN10018

    Drug

    The 7.5 mg/kg dose group will first enroll 3 to 6 subjects, and if the 7.5 mg/kg dose group is tolerable, then 3 to 6 subjects will continue to be enrolled into the 10 mg/kg dose group; if the 7.5 mg/kg dose group is not tolerable, a decision will be made to add a new, lower dose group after discussion between the sponsor and the investigator; in addition, based on the available study data, the sponsor and the investigator will discuss and decide whether to add an unplanned dose group or an exploratory group and decide on the appropriate recommended dose (RP2D) for the Phase IIa study. IN10018 is fixed dose at 100mg daily.

Treatment groups

124 Participants
are divided into 1 treatment group
Group A: HX009+IN10018Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RP2D

recommended phase 2 dose for HX009 in combination with IN10018 in advanced solid tumor

Time frame
Approximately 2 year
2

ORR

objective reponse rate per investigator by RECIST1.1

Time frame
approximately 2 years

Secondary outcomes

1

AEs

occurrency of AEs

Time frame
approximately 2 years
2

PFS

median progress-free survival per RECIST 1.1 by Investigator

Time frame
approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Hanx Biopharmaceuticals, Ltd.

Lead sponsor

Source ClinicalTrials.gov
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