A Study to Assess YH002 in Combination with YH001 in Subjects with Advanced Solid Tumors

NCT05169697 | Completed Phase 1 DMC

• 1 other identifier: YH002004
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 9

Brief Summary

A multicenter, open-label, phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination with YH001 in subjects with advanced solid tumors

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Determined the maximum tolerated dose (MTD)

  The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

  Up to 1 year after the last dosing

• Determined the recommended Phase II dose (RP2D)

  The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

  Up to 1 year after the last dosing

Study Arms (1)

YH002 in combination with YH001

EXPERIMENTAL

Dose escalation:A traditional 3+3 dose escalation algorithm will be utilized to identify MTD and/or RP2D Dose expansion:One selected dose after the escalation stage will be expanded to enroll additional 20 subjects. The subjects will be divided into two groups：A and B.

Drug: A:YH002+YH001; Drug: B:YH002+YH001; Drug: YH002+YH001

Interventions

A:YH002+YH001 DRUG

YH002 on CnD1,YH001 on CnD8,Q3W

YH002 in combination with YH001

B:YH002+YH001 DRUG

YH002 and YH001 on same day,Q3W

YH002 in combination with YH001

YH002+YH001 DRUG

A traditional 3+3 dose escalation algorithm

YH002 in combination with YH001

Eligibility Criteria

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

You may qualify if:

• To be eligible for study entry patients must satisfy all of the following criteria:
• Subjects must have the ability to understand and willingness to sign a written informed consent document.
• Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
• Subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason.
• Subjects must be age 18 to 80 years of age at the time of screening.
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥3 months based on investigator's judgement.
• Subjects have adequate bone marrow and other organ function at the screening visit.
• Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dosing. Women of reproductive potential are those who have not been post-menopausal for at least 12 months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy.

You may not qualify if:

• Subjects who meet any of the following criteria cannot be enrolled:
• Subjects have another active invasive malignancy within 5 years.
• Previous exposure to TNFR such as anti-OX40 antibodies.
• Subjects must not have received any anticancer therapy or another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study treatment(subject to the longer one).
• Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE 5.0, except alopecia ≤ Grade 2.
• Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
• Subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
• Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled diabetes (blood glucose \> 250 mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies
• Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.

Sponsors & Collaborators

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

Study Sites (9)

Orange Health Services

Orange, New South Wales, 2800, Australia

Location

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Henan Tumor Hospital

Zhengzhou, Henan, 450008, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110801, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

Location

Study Officials

• Hongming Pan

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

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 10, 2021
• First Posted: December 27, 2021
• Study Start: February 21, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: January 6, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); CN (5)