Clinical Trials

We Forge a More Promising Path Forward for Your Will to Fight

We are driven by a single purpose:

to turn groundbreaking science into new hope for patients battling difficult-to-treat cancers and neurodegenerative diseases. Clinical trials are a critical step in this journey, offering access to innovative investigational therapies before they are widely available.

We invite doctors and patients to explore the clinical studies listed below. Each trial represents a potential new path forward and a step closer to a cure.

Clinical trials recruiting now

We are currently recruiting patients for 4 clinical trials in a range of indications.

If you or someone you care about is battling cancer, we welcome you to learn more and get in touch.

BIPAVE-001
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

Indications: advanced or metastatic non-small cell lung cancers, colorectal cancers and angiosarcoma.

PRESERVE-003
A Phase 3 study of gotistobart versus docetaxel

Indications: Squamous cell carcinoma of the lung that progressed on chemotherapy and PD-1/PD-L1 inhibitor immunotherapy.

PRESERVE-006
A Phase 2 study examining the safety and efficacy of gotistobart in combination with lutetium Lu 177 vipivotide tetraxetan

Indications: Metastatic Castration-resistant Prostate Cancer

ONC-841-002
Safety, Pharmacokinetics (PK) and Efficacy of ONC-841 in Advanced Solid Tumors NCT06352359

Indications: Advanced or metastatic cancers

Active clinical trials not recruiting

Our heartfelt gratitude goes out to every patient, caregiver, and family who participated in these important trials. Our commitment continues, and we look forward to sharing the important learnings with the medical community in the future.

PRESERVE-001
A Phase 1 open-label study of gotistobart as a monotherapy and in combination with Pembrolizumab

Indications: Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cance, Ovarian Cance, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction adenocarcinoma, Cervical Cancer, Adenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma

PRESERVE-004
A Phase 2 study that compares two doses of gotistobart in combination with a fixed dose of pembrolizumab

Indications: Platinum-resistant ovarian cancer

PRESERVE-006
A Phase 2 study examining the safety and efficacy of gotistobart in combination with lutetium Lu 177 vipivotide tetraxetan

Indications: Metastatic Castration-resistant Prostate Cancer

PRESERVE-004
A Phase 2 study that compares two doses of gotistobart in combination with a fixed dose of pembrolizumab

Indications: Platinum-resistant ovarian cancer

Clinical trials recruiting soon

For further inquiries about our clinical trials, don’t hesitate to reach out.

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