Testing NWY001 in patients with advanced solid tumors

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

This study is testing a new treatment called NWY001 to see if it can help people with advanced solid tumors that haven't responded to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chipscreen Biosciences, Ltd. (Industry-sponsored)
• Drugs / interventions: trastuzumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05979155 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-arm, open-label study evaluates the safety and efficacy of NWY001 in patients with advanced solid tumors that have either relapsed from or are refractory to standard therapies, or for which no standard therapy exists. The study consists of two parts: a dose-escalation phase to determine the recommended Phase 2 dose (RP2D) and a dose-expansion phase where all patients receive the RP2D. Participants will be monitored for treatment response and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors that have not responded to standard treatments.

Not a fit: Patients with solid tumors that have effective standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited or no available therapies.

How similar studies have performed: Other studies have shown promise with similar dose-escalation approaches in advanced solid tumors, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Willingness to sign a written informed consent document
2. Participant with advanced solid malignant tumor that has relapsed from or is refractory to standard therapy or for which no standard therapy exists
3. 18\~75 years of age at the time of screening
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
5. Life expectancy ≥3 months
6. Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF, erythropoietin, and blood transfusion, within 14 days before first dose):

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:

1. major surgery ≥4 weeks
2. radiotherapy ≥4 weeks
3. endocrine therapy ≥2 weeks
4. chemotherapy (including antibody) ≥3 weeks
5. 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

1. 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
2. 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

Exclusion Criteria:

1\. Current or previous history of other active aggressive malignancies in the last 5 years, except :

1. 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
2. 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

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

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Cancer — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Ruihua Xu, Ph.D. — Sun Yat-sen University Cancer Cancer
• Study coordinator: Xinhao Wang

Conditions Advanced Solid Tumor