Neoplasms

Symptoms and General Pathology

All Conditions

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Micronutrients

Hematinics

Vitamins

Pemetrexed

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

TRC102 + pemetrexed

Bryan Leigh, MD

This study is being performed to evaluate the safety and tolerability of TRC102 in combination with Alimta. In addition to safety, this study will also evaluate pharmacokinetics and tumor response.

Study of TRC102 in Combination With Pemetrexed in Cancer Patients

Open Label Phase 1 Dose Finding Study of TRC102 in Combination With Pemetrexed in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable

Tracon Pharmaceuticals Inc.

Bryan Leigh, MD, Medical Monitor

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

Anti-Infective Agents

Antibodies

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Anti-Bacterial Agents

Antibiotics, Antitubercular

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

YH001

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.

Neoplasm Metastasis

Antibodies, Monoclonal

Carbamide Peroxide

Immunologic Factors

TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.

TRC105 chimeric anti-CD105 antibody

Bryan R Leigh, MD

This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.

In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.

Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable

TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression or unacceptable toxicity develops.

TRC093 recombinant humanized IgG1k monoclonal antibody

This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.

In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.

Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1, Open-label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of TRC102 in Combination With Pemetrexed in Cancer Patients	NCT00692159	Neoplasm	TRC102 + pemetr...	18 Years -	Tracon Pharmaceuticals Inc.
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.
Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer	NCT00582985	Cancer Neoplasm Metast...	TRC105 chimeric...	18 Years -	Tracon Pharmaceuticals Inc.
Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors	NCT00492830	Cancer Neoplasm Metast...	TRC093 recombin...	18 Years -	Tracon Pharmaceuticals Inc.

Spots Global Cancer Trial Database for tracon

Every month we try and update this database with for tracon 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 tracon

Every month we try and update this database with for tracon 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 tracon 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.