Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Administer BEY1107 in combination with Capecitabine, 3-weeks as 1 cycle.

Administer once daily, PO, 3-week continuous dose.

BEY1107

Administer twice daily, PO, 2-week continuous dose, followed by 1-week rest period.

BeyondBio Inc.

Beyondbio Inc.

This is a Phase 1/2 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with capecitabine in patients with metastatic colorectal cancer refractory or intolerant to standard of care (SoC).

In Phase 1, patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy will be enrolled at each dose level of BEY1107 in combination with Capecitabine. Phase 2 will be conducted after RP2D is determined on the Phase 1 results.

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Capecitabine in Patients With Metastatic Colorectal Cancer

An Open-label, Single Center, Phase I/II Clinical Trial to Assess the Maximum Tolerated Dose, Safety and Efficacy of BEY1107 in Combination With Capecitabine in Patients With Metastatic Colorectal Cancer Refractory or Intolerant to Standard of Care

MTD will be assessed based on adverse events(including DLT assessment), vital signs, 12-lead ECG, laboratory tests, etc.

ORR defined as proportion of subjects with a overall response of CR or PR

Plasma concentrations at each time point and PK parameters Cmax of BEY1107 will be assessed in the PK sampling cohort

Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort

Plasma concentrations at each time point and PK parameters AUClast of BEY1107 will be assessed in the PK sampling cohort

PFS is defined as the time from the start of study treatment to the date of the first documentation of objective PD or death due to any cause, whichever is earlier

DCR is defined as the proportion of participants who achieved a confirmed best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD)

Symptoms and General Pathology

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle.

Administer twice daily, PO, 4-week continuous dose.

Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.

This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Temozolomide in Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM)

An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination With Temozolomide in Patient With Recurrent or Progressive Glioblastoma Multiforme (GBM)

MTD will be assessed based on dose-limiting toxicity(DLT) assessment

PFS is defined as the time from the start of study treatment to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever is earlier

Plasma concentrations at each time point and PK parameters AUC last of BEY1107 will be assessed in the PK sampling cohort

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)

Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.

Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.

This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.

The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.

Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.

At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.

Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.

Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer

A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination With Gemcitabine in Patient With Locally Advanced or Metastatic Pancreatic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Capecitabine in Patients With Metastatic Colorectal Cancer	NCT05093907	Metastatic Colo...	BEY1107 Capecitabine	19 Years -	BeyondBio Inc.
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Temozolomide in Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM)	NCT05769660	Glioblastoma Mu...	BEY1107 Temozolomide	19 Years -	BeyondBio Inc.
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer	NCT03579836	Locally Advance...	BEY1107 Gemcitabine	20 Years - 80 Years	BeyondBio Inc.
Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient With Pancreatic Cancer	NCT03579836	Locally Advance...	BEY1107 Gemcitabine	20 Years - 80 Years	BeyondBio Inc.

Spots Global Cancer Trial Database for bey1107

Every month we try and update this database with for bey1107 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 bey1107

Every month we try and update this database with for bey1107 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 bey1107 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.