FWD1802 / Shenzhen Forward Pharma - LARVOL DELTA

Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Forward Pharmaceuticals Co., Ltd.

New P1 trial

FWD1802-001C: A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC. (clinicaltrials.gov) - P1/2 | N=99 | Recruiting | Sponsor: Forward Pharmaceuticals Co., Ltd. | Phase classification: P1 ➔ P1/2 | Trial completion date: Feb 2026 ➔ Mar 2028 | Trial primary completion date: Nov 2025 ➔ Mar 2026

First-in-human • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC (clinicaltrials.gov) - P1/2 | N=196 | Recruiting | Sponsor: Forward Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A phase 1/2, multi-part, open-label study of FWD1802, a novel oral selective estrogen receptor degrader (SERD), in patients with ER+/ HER2- locally advanced or metastatic breast cancer (BC) (SABCS 2025) - "Patients were heavily pretreated, receiving median 2 (1-7) lines of prior treatment in advanced setting, including 71% with prior CDK4/6i, 46% prior fulvestrant, and 52% prior chemotherapy. FWD1802 showed great safety and tolerability with no DLT and TEAEs mostly of Grade 1-2. In late-line mESR1+ ET-resistant patients in ph2 doses, FWD1802 showed a superb 41% (11/27) ORR (unconfirmed). Considering linear PK property and comparable safety profile between 75mg and 150mg, and the overall highly promising ORR under ph2 doses, 150mg was selected for future monotherapy studies."

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A phase Ib/II study of FWD1802, a novel oral estrogen receptor (ER) degrader (SERD), in combination with multiple CDK4/6 inhibitors (CDK4/6i) and mTOR inhibitor in ER+/HER2- advanced or metastatic breast cancer (a/m BC) (ESMO 2025) - "Here we report the open-label, phase 1b/2 study, evaluating the safety and clinical activity of FWD1802 plus palbociclib, ribociclib, abemaciclib, or everolimus in patients with ER+/HER2- a/mBC. Ph2 aims to further evaluate the antitumor activity of these combinations; the primary endpoint is ORR, and the secondary endpoints include antitumor activity (CBR, DOR, DCR, PFS, and OS), safety and PK characteristics of the combinations. Legal entity responsible for the study Forward Pharmaceuticals."

Combination therapy • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

A phase 1 FIH study of novel oral SERD FWD1802 in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer with or without ESR1 mutations. (ASCO 2025) - P1 | "FWD1802 is a novel oral SERD, which binds competitively to ER with higher affinity than fulvestrant... FWD1802 monotherapy was well tolerated with great safety and promising efficacy in a heavily treated population. Reponses were observed in patients carrying both wildtype and mutated ESR1, and better response observed in mESR1 patients. RP2D will be determined once data are collected on more patients."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Dyslipidemia • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC (clinicaltrials.gov) - P1/2 | N=196 | Not yet recruiting | Sponsor: Forward Pharmaceuticals Co., Ltd.

New P1/2 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer with or without ESR1 mutations (SABCS 2023) - "Mutated estrogen receptors are still sensitive to fulvestrant but with a much less sensitivity. In January 2023, elacestrant received its first approval for the treatment of postmenopausal women or adult men with breast cancer harboring ESR1 mutations in US...The monotherapy dose escalation (Part A) is currently ongoing. The dose selection for Part B and Part C will be based on the data from the ongoing Part A."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC. (clinicaltrials.gov) - P1 | N=99 | Recruiting | Sponsor: Forward Pharmaceuticals Co., Ltd.

Combination therapy • Metastases • Monotherapy • New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Forward Pharma completed a Series A+ funding of ten millions CNY (EqualOcean) - "Shenzhen Forward Pharmaceutical Co., Ltd ('Forward Pharma') recently has announced the completion of ten millions of CNY in Series A+ funding....According to Forward Pharma, this round of financing will be mainly used for the clinical trials of non-small cell lung cancer (NSCLC) targeting drug FWD1509, and the clinical development of the third-generation oral selective estrogen receptor degrader (SERD) FWD1802 in breast cancer."

Financing • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor