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PD-1 Antibody combined with Sapropterin Dihydrochloride

Sapropterin Dihydrochloride

Miao-Zhen Qiu, MD

Miao-zhen Qiu, MD

Rui-hua Xu, MD, PhD

The prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. However, research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies. In this context, researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment.

There is no standard treatment for patients with metastatic pancreatic cancer who failed to FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane). Patients with metastatic pancreatic cancer who are unable to tolerate or have failed to respond to standard chemotherapy will be enrolled in this clinical trial. They will be administered a combination treatment of Sapropterin Dihydrochloride and PD-1 antibody. The primary endpoints of this study are objective response rate and safety. The secondary endpoints will encompass overall survival, progression-free survival, and quality of life. The study aims to enroll a total of 20 participants.

PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment.

The percentage of patients whose cancer shrinks or disappears after treatment

The time from registration to death due to any cause, or censored at date last known alive.

PFS as measured in accordance with the irRECIST version 1.1

Innovent Biologics (Suzhou) Co. Ltd.

Sun Yat-sen University

Professor

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

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Dermatitis

Carcinoma, Squamous Cell

Nasopharyngeal Carcinoma

Radiodermatitis

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Pharmaceutical Solutions

In the dose escalation phase, 9 patients will be included in 3 groups with 3 patients as one group. In the dose expansion phase, the concentration of Sapropterin dihydrochloride tablets (BH4) aqueous solution will be performed according to the effective concentration of dose escalation phase, and 9 patients will be enrolled.

dose escalation phase (BH4) aqueous solution is sprayed onto the skin of all radiotherapy areas, 3 times a day until two weeks after the end of radiotherapy.

Sapropterin dihydrochloride tablets

Xingchen Peng, Ph.D

Head and neck squamous cell carcinoma (include nasopharyngeal carcinoma) is one of the most common malignant tumor in China, and radiotherapy is the main treatment method. Radiation-induced dermatitis is one of the most common complications of head and neck squamous cell carcinoma patients during radiotherapy. Severe radiation dermatitis will cause secondary infection, severe pain, and even lead to the interruption of radiotherapy. On the one hand, it will affect the efficacy of tumor treatment, which may affect the long-term survival of patients, and on the other hand, it will also seriously affect the quality of life of patients. Tetrahydrobiopterin（BH4）, also known as sapropterin, has been shown not only to reduce the severity of acute radiation dermatitis but also to enhance the repair of skin injury in animal experiments. It may be a new approach and method for the prevention and treatment of radiation-induced dermatitis

BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Phase Ia/Ib Clinical Trial of Sapropterin Dihydrochloride Tablets in the Prevention and Treatment of Radiation-induced Skin Reactions in Intensity Modulated Radiotherapy for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Radiation dermatitis is assessed according to the CTCAE 5.0 radiation dermatitis grading scale

Subjects' quality of life is assessed according to the Spitzer Quality-of-Life Index (SQLI)

West China Hospital

PhD, Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC	NCT06396637	Pancreatic Aden...	Sapropterin Dih...	18 Years - 75 Years	Sun Yat-sen University
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)	NCT05299203	Head and Neck S...	Sapropterin dih...	18 Years - 80 Years	West China Hospital
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)	NCT05299203	Head and Neck S...	Sapropterin dih...	18 Years - 80 Years	West China Hospital

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