nintedanib eye drop (CBT-001) / Cloudbreak Therap, China Grand Pharma - LARVOL DELTA

Efficacy and Underlying Mechanisms of Group Natural Psychotherapy for Anxiety Symptoms (clinicaltrials.gov) - P=N/A | N=55 | Recruiting | Sponsor: Beijing HuiLongGuan Hospital

New trial • Mood Disorders • Psychiatry

Preclinical Evaluation of [68Ga]Ga-CBT-001-2334 as the Promising PET Radiopharmaceutical for Carbonic Anhydrase IX Expression (SNMMI 2026) - "Our preclinical evaluations demonstrate [68Ga]Ga-CBT-001-2334 can selectively target CAIX. The Phase 0/1 clinical trials of [68Ga]Ga-CBT-001-2334 and preclinical therapeutic evaluations of [177Lu]Lu-CBT-001-2334 are currently underway to prove the high theranostic capability of CBT-001-2334."

Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Solid Tumor • CA9

Preclinical IND-Enabling Safety Assessment of a Novel CAIX-Targeted Gallium PET tracer, CBT-001-2334, for First-in-Human imaging use (SNMMI 2026) - "A single IV administration of 69Ga-CBT-001-2334 (5.4 mg/animal) was well tolerated in rats through Day 16 with no consistent adverse trends in clinical observations, body weight, hematology, or clinical chemistry. These findings support a provisional NOAEL suitable to enable a first-in-human evaluation and provide a large margin-to-human mass dose for the intended PET use. Integration of pending histopathology/organ weight results will complete the IND-enabling nonclinical safety package."

First-in-human • P1 data • Preclinical • Hematological Disorders • Solid Tumor • CA9

Preclinical Evaluation of [68Ga]Ga-CBT-001-2334 as the Promising PET Radiopharmaceutical for Carbonic Anhydrase IX Expression (SNMMI 2026) - "Our preclinical evaluations demonstrate [68Ga]Ga-CBT-001-2334 can selectively target CAIX. The Phase 0/1 clinical trials of [68Ga]Ga-CBT-001-2334 and preclinical therapeutic evaluations of [177Lu]Lu-CBT-001-2334 are currently underway to prove the high theranostic capability of CBT-001-2334."

Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Solid Tumor • CA9

A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium (clinicaltrials.gov) - P3 | N=660 | Active, not recruiting | Sponsor: Cloudbreak Therapeutics, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Ophthalmology

A Phase IIa Multicenter, Randomized, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CBT-001 Ophthalmic Solution in Patients With Primary or Recurrent Pterygium. (PubMed, Ophthalmol Sci) - "The drug was well tolerated with minimal detected systemic drug levels. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • P2a data • PK/PD data • Ophthalmology

A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Cloudbreak Therapeutics, LLC | Trial primary completion date: Dec 2024 ➔ Dec 2025 | Trial completion date: Jun 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Ophthalmology

C-Biomex collaborates with MD Anderson on radiopharmaceuticals for kidney cancer (Korea Biomedical Review) - "C-Biomex said Thursday that it has entered into a collaborative research agreement with MD Anderson Cancer Center to proceed with the U.S. investigational new drug (IND) application for its radiopharmaceutical therapy, CBT-001....MD Anderson and C-Biomex will conduct the entire clinical trial of CBT-001 at the U.S. institution to meet the FDA’s IND requirement."

Licensing / partnership • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma

A Clinical Trial of CBT-001 in Patients With Pterygium (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Cloudbreak Therapeutics, LLC

New P3 trial • Ophthalmology