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Advanced Solid TumorPhase 1NCT05979155

A Study of NWY001 in Subjects With Advanced Solid Tumors

A Phase 1 study testing NWY001 in people with Advanced Solid Tumor, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
NWY001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteChina
Study dates
5 Jan 2024to May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Life expectancy ≥3 months
  • Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF, erythropoietin, and blood transfusion, within 14 days before first dose):
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  • 1) absolute neutrophil count (ANC) ≥1.5×109/L 2) platelet ≥100×109/L 3) hemoglobin ≥90 g/L 4) creatinine clearance >50 mL/min (according to Cockcroft-Gault equation) 5) both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal (ULN) (≤5×ULN for patients with hepatic metastasis) 6) total bilirubin ≤1.5×ULN (≤3×ULN for patients with gilbert syndrome) 7) international normalized ratio (INR) <2.0, activated partial thromboplastin time (aPTT) ≤1.5×ULN
  • 7. Prior anti-cancer therapy meets the following criteria:
  • major surgery ≥4 weeks
  • radiotherapy ≥4 weeks
  • endocrine therapy ≥2 weeks
  • chemotherapy (including antibody) ≥3 weeks
  • immunotherapy ≥4 weeks
  • 8. At least one measurable target lesion as defined by RECIST1.1
  • 9. For part 2a: Participant has a diagnosis of histologically confirmed advanced (unresectable) or metastatic gastric or gastroesophageal junction adenocarcinoma
  • participant with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) is refractory or intolerant to standard therapy or for which no standard therapy exists. Prior treatment with trastuzumab or HER2-targeted drugs
  • participant with no HER2 expression is refractory or intolerant to standard therapy or for which no standard therapy exists
  • 10. For part 2b: Participant has a diagnosis of histologically confirmed advanced esophageal squamous carcinoma
  • 11. For part 2c: Participant has a diagnosis of histologically confirmed advanced pancreatic ductal adenocarcinoma
  • 12. For part 2d: Participant has a diagnosis of histologically confirmed advanced hepatocellular carcinoma
  • 13. For part 2e: Participant has a diagnosis of histologically confirmed advanced intrahepatic cholangiocarcinoma
  • 14. For part 2f: Participant has a diagnosis of histologically confirmed advanced MSI-H/dMMR colorectal cancer

Who cannot join

  • 1. Current or previous history of other active aggressive malignancies in the last 5 years, except :
  • 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)
  • 2. Current or previous history of hematological malignancies
  • 3. Primary central nervous system (CNS) malignancies or CNS metastases
  • 4. History of allergy or hypersensitivity to monoclonal antibodies or excipients, or a known history of allergy to antibodies produced by Chinese hamster ovary cell
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  • 5. Uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal medications
  • 6. History of clinically significant lung diseases (such as interstitial pneumonia, pneumonia, pulmonary fibrosis, and severe radiation pneumonia), or patients suspected of having these diseases on radiographic examination during the screening period
  • 7. Uncontrolled complications, including, but not limited to, persistent active infections, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled chest and abdominal fluid accumulation, psychiatric disorders that do not meet study requirements, and other serious conditions requiring systemic treatment
  • 8. Known history of HIV, active infections of hepatitis B or hepatitis C
  • 9. Active pulmonary tuberculosis. Participants vaccinated with BCG vaccine may be false positive for PPD, and they could be enrolled if negative for IGRA
  • 10. Women who are pregnant or breastfeeding or intended to become pregnant during the study period
  • 11. Participants of childbearing potential who refuse to take highly effective contraceptive measures during the entire study treatment period and for 120 days after the last dose of study drug

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinhao Wang contact

+86 0755-36993550

xinhwang@chipscreen.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Cancer

    Guangzhou, Guangdong, 510060

    Ruihua Xu, Ph.D., +86 020-87343795, xurh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Non-randomized, Open-label, Multiple-Dose Phase I Study of NWY001, in Subjects With Advanced Solid Tumors

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

Read the detailed description

Part 1: Patients with advanced solid tumors that has relapsed from or is refractory to standard therapy or for which no standard therapy exists will be enrolled in different cohorts.

Part 2: Recommended Phase 2 dose (RP2D) of NWY001 will be given to all patients enrolled in this part.

Being tested
NWY001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NWY001Biological

    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.

  • NWY001Biological

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

Study groups in NCT05979155
Study groupRoleWhat they receive
Study arm (multiple doses of NWY001)ExperimentalPart 1: dose-escalation of monotherapy NWY001
Receives: Biological: NWY001
Study arm (RP2D of NWY001)ExperimentalPart 2: dose-expansion of monotherapy NWY001
Receives: Biological: NWY001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Number of patients experienced any dose limited toxicity

    Measured: Up to 21 days

  2. Incidence of adverse events (AEs)

    Number of patients experienced AEs

    Measured: Until 30 days after the last dose of the study drug

Secondary outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: Until 30 days after the last dose of the study drug

  4. Maximum plasma concentration (Cmax)

    Pharmacokinetic profile of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  5. Time to Cmax (Tmax)

    Pharmacokinetic profile of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  6. Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)

    Pharmacokinetic profile of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  7. Tumor necrosis factor-α (TNF-α)

    Pharmacodynamic profile of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  8. Interleukin-6 (IL-6)

    Pharmacodynamic profile of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  9. Incidence of anti-drug antibody (ADA)

    Immunogenicity of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

  10. Incidence of neutralizing antibody (NAb)

    Immunogenicity of NWY001

    Measured: From pre-dose to 30 days after the last dose of the study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start5 Jan 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979155
Sponsor's protocol ID
NWY001-101
Status last verified
Jul 2024
First submitted
20 Jul 2023
Last updated
16 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NWY001 in people with Advanced Solid Tumor, run by Chipscreen Biosciences, Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinhao Wang (+86 0755-36993550, xinhwang@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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