Health TrialsbyHealthPanel

A Study of NWY001 in Subjects With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChipscreen Biosciences, Ltd.

About this trial

This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts:

Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willingness to sign a written informed consent document

Participant with advanced solid malignant tumor that has relapsed from or is refractory to standard therapy or for which no standard therapy exists

18~75 years of age at the time of screening

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Disqualifiers

previous history of non-aggressive malignancies, such as cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast that remains in complete remission for years after curative treatment

malignancies with negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and focal prostate cancer)

Trial design

Design model

Sequential

Treatments tested in this trial

  • NWY001

    Biological/Vaccine

    Part 1: Participants will be given a single-dose of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.

  • NWY001

    Biological/Vaccine

    Part 2: Participants will be given RP2D of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: Study arm (multiple doses of NWY001)Experimental treatment 1 intervention
Group B: Study arm (RP2D of NWY001)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Number of patients experienced any dose limited toxicity

Time frame
Up to 21 days
2

Incidence of adverse events (AEs)

Number of patients experienced AEs

Time frame
Until 30 days after the last dose of the study drug

Secondary outcomes

1

Objective response rate (ORR)

The proportion of patients who have a complete response (CR) or partial response (PR), as determined by the Investigator at local site per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Time frame
Until 30 days after the last dose of the study drug
2

Disease control rate (DCR)

The proportion of patients who have a CR or PR or stable disease (SD), as determined by the Investigator at local site per RECIST 1.1

Time frame
Until 30 days after the last dose of the study drug
3

Progression free survival (PFS)

Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause

Time frame
Until 30 days after the last dose of the study drug
4

Maximum plasma concentration (Cmax)

Pharmacokinetic profile of NWY001

Time frame
From pre-dose to 30 days after the last dose of the study drug

Other outcomes

Sponsors and contacts

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

Chipscreen Biosciences, Ltd.

Lead sponsor

Source ClinicalTrials.gov
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