A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGanzhou Hemay Pharmaceutical Co., Ltd

About this trial

An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who voluntarily signed a written informed consent form before the start of the study;

Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .

Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;

At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) [Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included].

Disqualifiers

Women during pregnancy or breastfeeding;

HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;

Having received drug treatment from another clinical trial within the four weeks prior to enrolment;

Aallergy to the active ingredient or excipients of the investigational medicinal product;

Trial design

Design model

Single group

Treatments tested in this trial

  • Hemay181

    Drug

    intravenous infusion,once every 3 weeks

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy indicators

Objective response rate (ORR)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

Safety indicators

Occurrence of adverse events (AEs) and serious adverse events (SAEs)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Other outcomes

Sponsors and contacts

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