SPH4336 / Shanghai Pharma - LARVOL DELTA

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: May 2026 ➔ Dec 2026

Monotherapy • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Phase classification: P=N/A ➔ P1

Phase classification • Breast Cancer • CNS Tumor • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and safety of SPH4336 plus endocrine therapy in HR-positive/HER2-negative metastatic breast cancer with brain metastases: A multicenter, single-arm, phase II study. (ASCO 2026) - P2 | "Patients received SPH4336 (400 mg orally once daily) plus physician's choice of endocrine therapy (letrozole, fulvestrant, or exemestane) in 28-day cycles until disease progression or unacceptable toxicity... SPH4336 plus endocrine therapy demonstrated clinically meaningful intracranial antitumor activity with a manageable safety profile in HR+/HER2- MBC with brain metastases. These findings warrant further investigation in randomized studies for this patient population with high unmet medical need."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ May 2026

Monotherapy • Trial completion date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. (PubMed, Oncologist) - P1/2 | "SPH4336 demonstrated an acceptable safety profile and dose-dependent plasma exposure in patients with various advanced solid tumors. (ClinicalTrials.gov Identifier: NCT05905614; IRB Approved.)."

Journal • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov) - P2 | N=14 | Terminated | Sponsor: Shanghai Pharma Biotherapeutics USA Inc. | N=33 ➔ 14 | Trial completion date: Mar 2025 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2025 ➔ Oct 2024; Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Shanghai Pharmaceuticals’ SPH4336 tablets were approved for clinical trials, and they will work together with osimertinib to fight against advanced KRAS mutant tumors. [Google translation] (pharnexcloud.com) - "On September 18, according to the latest announcement on the CDE official website, SPH4336 tablets submitted by Shanghai Pharmaceuticals obtained implicit approval for a new clinical trial, with the proposed indication being the combination with osimertinib for the treatment of advanced solid tumors with KRAS mutations."

New trial • Oncology • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Aug 2024 ➔ Nov 2024

Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Oct 2023 | Trial primary completion date: Jun 2024 ➔ Oct 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

First-in-human phase 1 study of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "This study demonstrated that SPH4336 was well tolerated at doses ranging from 50 to 600 mg dose levels. A dose of 400 mg could be considered for further clinical trials. Clinical trial information: NCT05905614."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Hematological Disorders • Oncology • Sarcoma • Solid Tumor • CDK4

Shanghai Pharmaceuticals (601607.SH): Terminate clinical trials and subsequent development of four R&D projects: B001, B001-A, I022 (combination therapy, first-line treatment for breast cancer) and I022-K [Google translation] (iis.aastocks.com) - "Shanghai Pharmaceuticals...announced that based on a comprehensive assessment of the future market value of the R&D projects, business synergy, and subsequent development investment, it decided to terminate the clinical trials and subsequent development of the four R&D projects B001, B001-A, I022...and I022-K."

Discontinued • Trial termination • Breast Cancer • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Active, not recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023 ➔ Sep 2023

Combination therapy • Enrollment open • Trial initiation date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=254 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Initiation date: Jul 2023 ➔ Oct 2023

Combination therapy • Metastases • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases. (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Initiation date: Jun 2023 ➔ Oct 2023

Combination therapy • Trial initiation date • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=63 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Shanghai Pharma Biotherapeutics USA Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Mar 2025 | Initiation date: Dec 2022 ➔ Jul 2023 | Trial primary completion date: Dec 2025 ➔ Mar 2025

Enrollment open • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer (clinicaltrials.gov) - P2/3 | N=374 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Active, not recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Metastases • New P1/2 trial • Oncology • Solid Tumor