Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Sarcoma

Carcinoma, Renal Cell

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Neoplasms, Germ Cell and Embryonal

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenoma

Neoplasms, Mesothelial

Head and Neck Neoplasms

Renal Cell Carcinoma

Stomach Cancer

Soft Tissue Sarcoma

Clear Cell Renal Cell Carcinoma

Germ Cells Tumors

Malignant Mesothelioma

Testicular Germ Cell Tumor

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Tislelizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Participants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Participants will be administered HFB200301 as described in the experimental arm.

HFB200301

Participants will be administered tislelizumab as described in the experimental arm.

Emily Lefkovitz, Clinical Trial Manager

The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.

This is a Phase 1a/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of

1. A Screening Period
2. A Treatment Period during which participants will receive the study drug on the first day of each cycle
3. A Follow-up Period

A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

Percent change in immunologic changes to immune cells

HiFiBiO Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors	NCT05238883	Gastric Cancer Renal Cell Carc... Melanoma Sarcoma Testicular Germ... Cervical Cancer Mesothelioma Non Small Cell ... Head and Neck S...	HFB200301 Tislelizumab	18 Years -	HiFiBiO Therapeutics
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors	NCT05238883	Gastric Cancer Renal Cell Carc... Melanoma Sarcoma Testicular Germ... Cervical Cancer Mesothelioma Non Small Cell ... Head and Neck S...	HFB200301 Tislelizumab	18 Years -	HiFiBiO Therapeutics

Spots Global Cancer Trial Database for hfb200301

Every month we try and update this database with for hfb200301 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 hfb200301

Every month we try and update this database with for hfb200301 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 hfb200301 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.