A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors

NCT04699929 | Completed Phase 1

• 1 other identifier: YH001003
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label, dose-escalation study of the study drug YH001 . The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of YH001 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Overall safety and tolerability profile of YH001 (adverse events)

  The safety profile of YH001 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  From screening up to 1 year

• Maximum tolerated dose (MTD)

  The MTD will be determined based on the data of safety and tolerability

  Cycle 1 of each cohort. Duration of one cycle is 21 day

• Recommended phase 2 dose (RP2D)

  The RP2D will be determined based on the data of safety and tolerability

  Cycle 1 of each cohort. Duration of one cycle is 21 day

Secondary Outcomes (4)

• Maximum serum concentration (Cmax)

  Up to 1 year

• Trough concentration before the next dose is administered (Ctrough)

  Up to 1 year

• Time to reach maximum serum concentration (Tmax)

  Up to 1 year

• Clearance (CL)

  Up to 1 year

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

All subject will receive YH001 intravenously as single agent every three weeks (Q3W) for up to 1 years, until intolerable toxicity, confirmed disease progression, withdrawal of consent, or Investigator decision, whichever comes first.

Drug: YH001

Interventions

YH001 DRUG

YH001 will be administered intravenously over 60minutes every three weeks (Q3W) for up to 1 years .

Intervention/treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years;
• Patients with histologically or cytologically confirmed solid tumors who have failed standard of care or have no standard of care;
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
• Have life expectancy of at least 3 months based on investigator's judgement;
• Organ function levels must meet the following requirements:
• A:Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count ≥ 100 x 10\^9/L, hemoglobin (Hb) ≥ 100 g/L ; B:Liver: serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (patients with primary liver cancer or liver metastases: AST and/or ALT \< 5 × ULN); C:Kidney: creatinine clearance (CrCL) ≥ 50 mL/min;
• International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
• All women of reproductive potential, men whose partner is a woman of reproductive potential, or their spouses should use adequate barrier contraception throughout the study and for 3 months after the last dose;
• Voluntary and agree to sign the informed consent and follow the study treatment protocol as well as follow-up plan.

You may not qualify if:

• Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded;
• Patients with any other malignancy within the past 5 years or currently, except for completely cured non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;
• Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose, or received modern Chinese medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to the first dose;
• Major surgery (excluding vascular access establishment surgery) was received within 4 weeks prior to the first dose;
• Has received immunosuppressive therapy within 4 weeks prior to the first dose. However, enrollment is permitted under the following circumstances:
• In the absence of active autoimmune disease, patients are allowed to receive inhaled or topical glucocorticoids, or other glucocorticoids at doses ≤ 10 mg/day prednisone equivalent.
• Patients with primary central nervous system (CNS) tumors, or symptomatic CNS tumors, or spinal cord compression, or carcinomatous meningitis; with the following exceptions:
• Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms due to brain metastatic sites, no need for corticosteroids, and lesion size ≤ 1.5 cm); Patients whose symptoms are controlled by treatment, i.e., their condition is stable and asymptomatic at least 4 weeks after treatment;
• Use of any other study drug within 4 weeks prior to the first dose, or participation in other clinical studies;
• Have received live or attenuated vaccines within 4 weeks prior to the first dose;
• Patients with known severe allergic reactions (≥ Grade 3) to the active ingredient and excipients of the investigational drug, other monoclonal antibodies or "Immuno-oncology drugs;
• Toxic and side effects caused by prior anti-tumor therapy before the first dose did not recover to ≤ Grade 1 (CTCAE v5.0), except for alopecia and sensory neuropathy below Grade 2;
• History of interstitial pneumonia or non-infectious pneumonitis requiring corticosteroids, except for radiation therapy, or current presence of interstitial pneumonia or non-infectious pneumonitis;
• ≥ Grade 2 immune-related pneumonitis occurred during prior immunotherapy;
• History of ≥ Grade 3 immune-related adverse reactions or any adverse reactions leading to discontinuation of immunotherapy during prior immunotherapy;

Sponsors & Collaborators

• Eucure (Beijing) Biopharma Co., Ltd: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 7, 2021
• Study Start: January 26, 2021
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-05

Locations

CN (3)