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.

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

YH001

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.

This is a single arm clinical trial in subjects with advanced solid tumor receiving multiple doses of YH001 intravenously (IV). YH001 will be administered (IV) in 19-37 patients with advanced solid tumors. An accelerated titration method followed by a traditional 3+3 dose escalation scheme will be utilized to determine MTD(maximum tolerated dose) and/or RP2D(recommended phase 2 dose). Patients will be dosed at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G every 3 weeks (Q3W) for 15 weeks (5 cycles).

A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors

A Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability,Efficacy and Pharmacokinetics of YH001 in Subjects With Advanced Solid Tumors

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

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

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

Eucure (Beijing) Biopharma Co., Ltd

Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Sarcoma

Chondrosarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.

Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.

Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks

Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks and Doxorubicin every 3 weeks for a maximum of 6 doses

Envafolimab

James Freddo, MD

This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

A Phase 1/2 Study of YH001 in Combination With Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Evaluate safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies.

Evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed SC every 3 weeks and doxorubicin dosed every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin and are refractory to or intolerant to other available therapies.

Determine the ORR of envafolimab, YH001 and doxorubicin by RECIST 1.1 by investigator assessment in patients who have not received immune checkpoint inhibitors or doxorubicin with subtypes of advanced or metastatic soft tissue sarcoma.

Determine the ORR of envafolimab and YH001 by RECIST 1.1 by investigator in patients with subtypes of advanced or metastatic soft tissue sarcoma who have not received immune checkpoint inhibitors.

Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.

Determine envafolimab trough concentration when given with YH001 with or without doxorubicin.

Evaluate the formation of YH001 anti-drug antibodies (ADA).

Evaluate the formation of envafolimab anti-drug antibodies (ADA).

Assess objective response rate (ORR) of YH001 by investigator using RECIST 1.1 when combined with envafolimab or envafolimab/doxorubicin combination in patients with advanced or metastatic sarcoma.

Determine the Disease Control Rate of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

Determine the Duration of Response of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

Determine Progression Free Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

Determine Overall Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

Type, incidence, severity (graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] Version 5.0), timing, seriousness, and relatedness of AEs and laboratory abnormalities.

Tracon Pharmaceuticals Inc.

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

YH003 will be administered intravenously over 60 minutes every 21-day cycle.

YH003

YH001 will be administered intravenously over 60 minutes every 21-day cycle.

Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.

Fangxia Pan

Amanda Bryant

Tracy Liaw

Nikki Cross

Albert Goikhman

A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects with Advanced Solid Tumors

A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors

A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors

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

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

All the patients will receive YH001 intravenously as single agent for 21 days followed by combination phase.

YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G.

Toripalimab will be administered by intravenously (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle.

Toripalimab

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

This trial will have a run-in phase to explore the safety and tolerability of YH001 as a single agent for 21 days as DLT observation period then followed by a combination phase to further explore the safety and tolerability of YH001 combined with Toripalimab (anti-PD-1 antibody) for each dose level during dose escalation.

The dose escalation will follow the traditional "3 + 3" dose escalation scheme. These subjects will be treated with YH001 and Toripalimab. YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G. Toripalimab will be administered by IV (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle. A single subject will be enrolled at Dose A as starting dose of YH001, and subsequent cohort will be expanded to include 3-6 subjects.

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

A First-in-human (FIH), Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors

MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle

DLT is defined as a toxicity (adverse event at least possibly related to YH001) occurring during the DLT observation period (the initial 21 days) both in run-in phase of YH001 as single agent and in combination phase of YH001 in combination with Toripalimab

To determine the PK profile of YH001 alone and in combination with Toripalimab

To assess the immunogenicity of YH001 in combination with Toripalimab

To assess the preliminary antitumor activity of YH001 in combination with Toripalimab

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors	NCT04699929	Advanced Solid ...	YH001	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma	NCT05448820	Advanced Sarcom... Metastatic Sarc... Soft Tissue Sar...	YH001 Envafolimab Doxorubicin	18 Years -	Tracon Pharmaceuticals Inc.
A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors	NCT04699929	Advanced Solid ...	YH001	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors	NCT05176509	Solid Tumor	YH003 YH001 Pembrolizumab	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors	NCT04699929	Advanced Solid ...	YH001	18 Years -	Eucure (Beijing) Biopharma Co., Ltd
A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors	NCT04357756	Advanced Solid ...	YH001 Toripalimab	18 Years -	Eucure (Beijing) Biopharma Co., Ltd

Spots Global Cancer Trial Database for yh001

Every month we try and update this database with for yh001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yh001

Every month we try and update this database with for yh001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yh001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.