SIM0505 / Simcere, NextCure - LARVOL DELTA

SIM0505-101: A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=738 | Recruiting | Sponsor: NextCure, Inc. | N=414 ➔ 738

Enrollment change • First-in-human • Platinum resistant • Breast Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Serous Adenocarcinoma • Fallopian Tube Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Papillary Renal Cell Carcinoma • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Papillary Carcinoma • Uterine Cancer • BRCA • CDH6 • EGFR • FOLR1

Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. (ASCO 2026) - P1 | "22 (75.9%), 20 (69.0%) and 2 (6.9%) had received bevacizumab, PARPi and mirvetuximab soravtansine (MIRV), respectively. SIM0505, a first in class CDH6 CPT116 payload ADC showed manageable safety and tolerability, including at higher dose levels with encouraging efficacy in OC and USC, with a favorable PK profile. These data support initiating the dose optimization portion of the study in gynecological cancers."

ADC • Clinical • First-in-human • Metastases • P1 data • Endometrial Cancer • Endometrial Serous Adenocarcinoma • Febrile Neutropenia • Genito-urinary Cancer • Gynecologic Cancers • Interstitial Lung Disease • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • Thrombocytopenia • Uterine Cancer • CDH6 • MUC16

NextCure reports 55% response rate for SIM0505 in gynecologic cancers (Investing.com) - "The Phase 1 study evaluated SIM0505 in 59 heavily pre-treated cancer patients...For patients within therapeutic dose cohorts of 4.8 to 8.0 mg/kg who had minimum 12 weeks of follow-up, the objective response rate was 55% for gynecologic cancers, 52.9% for ovarian cancer, and 66.7% for uterine serous carcinoma...NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers in May 2026, initially focusing on patients with platinum-resistant ovarian cancer. The global study is expected to enroll up to 120 patients at sites in the U.S., Canada, the EU and China."

P1 data • Platinum resistant • Trial status • Gynecologic Cancers • Ovarian Cancer

NextCure…and Simcere Zaiming Pharmaceutical…announced initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer (GlobeNewswire) - "'The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe'."

Platinum resistant • Trial status • Ovarian Cancer

NextCure…and Simcere Zaiming Pharmaceutical…announced a poster will be presented at ASCO 2026 highlighting Phase 1 data for SIM0505 in the treatment of solid tumors (GlobeNewswire) - "Poster to be presented at the American Society for Clinical Oncology on Monday, June 1, 2026."

P1 data • Platinum resistant • Ovarian Cancer • Solid Tumor

NextCure, Inc…announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. (GlobeNewswire) - "We are committed to bringing SIM0505 to patients as quickly as possible and we plan to initiate dose optimization in ovarian cancer patients in the second quarter of 2026. In addition, we look forward to presenting Phase 1 data on the program at the upcoming 2026 American Society of Clinical Oncology conference."

Fast track • P1 data • Platinum resistant • Trial status • Ovarian Cancer

NextCure and Simcere’s SIM0505 (CDH6 ADC) Abstract Accepted for ASCO 2026 (GlobeNewswire) - "The ongoing open-label, Phase 1 study (NCT06792552) is evaluating SIM0505 in advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer."

P1 data • Platinum resistant • Ovarian Cancer

…Near-Term Milestones: SIM0505 (CDH6 ADC)… (GlobeNewswire) - "Data from the Phase 1 open-label dose escalation study is expected to be presented in the second quarter of 2026, including results from patients in the U.S. and China. The study (NCT06792552) is evaluating SIM0505 in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer (PROC). Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027."

P1 data • Platinum resistant • Trial status • Ovarian Cancer

NextCure Announces Closing of $21.5 Million PIPE Financing in Advance of First Half 2026 Phase 1 POC Data Readouts (GlobeNewswire) - "NextCure intends to use the net proceeds from the offering for general working capital needs, extending the company’s cash runway into the first half of 2027, which is beyond the planned first half of 2026, proof of concept data readouts of its two antibody drug conjugate (ADC) programs, SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC)."

Financing • Solid Tumor

NextCure and Simcere Zaiming Announce Expansion of Ongoing Phase 1 Trial of SIM0505 (CDH6 ADC) into the United States (GlobeNewswire) - "...The first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors....Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026."

P1 data • Trial status • Solid Tumor

SIM0505-101: A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=414 | Recruiting | Sponsor: NextCure, Inc. | N=172 ➔ 414

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results (Nasdaq) - "SIM0505 (CDH6 ADC): Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025. Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026."

P1 data • Trial status • Oncology • Solid Tumor

NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6 (The Manila Times) - "NextCure...and Simcere Zaiming...announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025....The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC....Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory."

Licensing / partnership • New trial • Solid Tumor

SIM0505-101: A Phase I Study of SIM0505 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase I Study of SIM0505 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

11 Class 1 innovative drugs were approved for clinical trials in China for the first time!… [Google translation] (Sina Corp) - "The Class 1 new drug MHB009C for injection, which was applied by Minghui Pharmaceutical, has been approved for clinical trials and is intended to be developed for the treatment of patients with advanced malignant solid tumors. The specific mechanism of action of this product has not yet been found in public information, but the acceptance number shows that this is a new biological product....SIM0505, a Class 1 new drug for injection filed by Innovent, a subsidiary of Innovent, has been approved for clinical trials and is intended to be used to treat advanced solid tumors."

New trial • Solid Tumor