SP-002 / Transgene, Stamford Pharma - LARVOL DELTA

A Review of Hedgehog Pathway Inhibitors in Combination Therapy for Basal Cell Carcinoma (AAD 2026) - "A total of nine studies were included, involving either vismodegib or sonidegib combined with concomitant therapy of either itraconazole, radiation therapy, photodynamic therapy (PDT), pembrolizumab, intratumoral immunotherapy ASN-002, or surgical debulking. Lastly, 75% of combination therapy studies reported a more tolerable AE when compared to monotherapy. Combination strategies represent a promising avenue to optimize efficacy, improve tolerability, and expand therapeutic options for patients with BCC."

Combination therapy • Review • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Stamford Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: Ascend Biopharmaceuticals Ltd | Recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial primary completion date: Jul 2023 ➔ Feb 2024

Phase classification • Trial completion • Trial primary completion date • Basal Cell Carcinoma • Oncology • Rare Diseases • Skin Nodular Basal Cell Carcinoma

Stamford Pharmaceuticals Inc Announces the First Patient to Be Treated with SP-002 in Combination with Erivedge in a Phase 2 Study in Locally Advanced BCC Subjects (PRNewswire) - "Stamford Pharmaceuticals Inc...today announced initiation of its locally advanced basal cell carcinoma (laBCC) trial (NCT06344052). The study will evaluate SP-002, an adenoviral-based immunotherapy, in combination with Roche's vismodegib (Erivedge), a Hedgehog Pathway inhibitor (HHPI), approved for the treatment of adult patients presenting with locally advanced and metastatic basal cell carcinoma....SP-002-004 is a multi-center randomized, phase 2 study that will enroll patients with locally advanced BCC patients. Patients will be randomized to receive oral vismodegib in combination with intratumoral injection of SP-002 or vismodegib alone."

Trial status • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Stamford Pharmaceuticals, Inc.

New P2 trial • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS) (clinicaltrials.gov) - P1b/2a | N=24 | Suspended | Sponsor: Ascend Biopharmaceuticals Ltd | Trial completion date: Mar 2023 ➔ Mar 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Rare Diseases

Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor (clinicaltrials.gov) - P2a | N=18 | Recruiting | Sponsor: Ascend Biopharmaceuticals Ltd | N=84 ➔ 18 | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jul 2022 ➔ Jul 2023

Enrollment change • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Rare Diseases • Skin Nodular Basal Cell Carcinoma

Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS) (clinicaltrials.gov) - P1b/2a; N=24; Suspended; Sponsor: Ascend Biopharmaceuticals Ltd; Trial completion date: Mar 2022 ➔ Mar 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Rare Diseases

Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor (clinicaltrials.gov) - P2a; N=84; Recruiting; Sponsor: Ascend Biopharmaceuticals Ltd; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Apr 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Rare Diseases • Skin Nodular Basal Cell Carcinoma

[VIRTUAL] A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Gusacitinib (ASN002) in Subjects with Moderate-to-Severe Chronic Hand Eczema (EADV 2020) - No abstract available

Clinical • Late-breaking abstract • P2b data • PK/PD data • Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology