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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169697
• Other study ID #: YH002004
• Status: Recruiting
• Phase: Phase 1
• Start date: February 21, 2022
• Est. completion date: February 21, 2025

Study information

• Verified date: July 2023
• Source: Eucure (Beijing) Biopharma Co., Ltd
• Contact: Fangxia Pan
• Phone: +86 01085950770
• Email: fangxia.pan[@]eucure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be eligible for study entry patients must satisfy all of the following criteria:

1. Subjects must have the ability to understand and willingness to sign a written informed consent document.

2. Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.

3. 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.

4. Subjects must be age 18 to 80 years of age at the time of screening.

5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6. Life expectancy =3 months based on investigator's judgement.

7. Subjects have adequate bone marrow and other organ function at the screening visit.

8. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (ß -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.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be enrolled:

1. Subjects have another active invasive malignancy within 5 years.

2. Previous exposure to TNFR such as anti-OX40 antibodies.

3. 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).

4. 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.

5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.

6. 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.

7. 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

8. Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• A:YH002+YH001
YH002 on CnD1,YH001 on CnD8,Q3W
• B:YH002+YH001
YH002 and YH001 on same day,Q3W
• YH002+YH001
A traditional 3+3 dose escalation algorithm

Locations

Country	Name	City	State
Australia	Peninsula and South Eastern Haematology & Oncology Group	Frankston	Victoria
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Australia	Orange Health Services	Orange	New South Wales
Australia	Macquarie University Hospital	Sydney	New South Wales
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Tumor Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eucure (Beijing) Biopharma Co., Ltd

Countries where clinical trial is conducted

Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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