A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors

ConditionSolid Tumors
Trial statusNot yet recruiting
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 shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v6.0) [except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk];

Disqualifiers

Women during pregnancy or breastfeeding;

Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;

Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Hemay5087

    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

Number of participants with adverse events

Time frame
3 weeks of treatment
2

Incidence of dose-limiting toxicity (DLT) in each dose group

Time frame
3 weeks of treatment
3

Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181

Time frame
3 weeks of treatment
4

Subsequent recommended doses of Hemay181

Time frame
3 weeks of treatment

Secondary outcomes

1

Objective Response Rate

Time frame
3 weeks of treatment
2

Duration of Response

Time frame
3 weeks of treatment
3

Disease Control Rate

Time frame
3 weeks of treatment
4

Time to Response

Time frame
3 weeks of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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