DCSZ11 / DynamiCure Biotech - LARVOL DELTA

Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jul 2030 ➔ Oct 2030 | Initiation date: Jul 2026 ➔ Oct 2026 | Trial primary completion date: Jul 2030 ➔ Oct 2030

Mismatch repair • pMMR • Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Mismatch repair • New P2 trial • pMMR • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=9 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Jun 2027

Enrollment open • Trial initiation date • Trial primary completion date • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • EGFR • HER-2 • NTRK • PD-L1 • ROS1

A Prospective Single-Arm Clinical Study of DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=9 | Not yet recruiting | Sponsor: West China Hospital

New P1/2 trial • Head and Neck Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=320 | Recruiting | Sponsor: DynamiCure Biotechnology | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial primary completion date • Colorectal Cancer • Non Small Cell Lung Cancer • Solid Tumor

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=257 | Recruiting | Sponsor: DynamiCure Biotechnology | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=251 | Recruiting | Sponsor: DynamiCure Biotechnology | N=96 ➔ 251

Enrollment change • Metastases • Monotherapy • Oncology • Solid Tumor

DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: DynamiCure Biotechnology | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: DynamiCure Biotechnology

Metastases • Monotherapy • New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

DCBY02 or DCSZ11 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: DynamiCure Biotechnology | N=96 ➔ 192

Enrollment change • Metastases • Monotherapy • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: DynamiCure Biotechnology | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: DynamiCure Biotechnology

Monotherapy • New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

DynamiCure Announces IND Clearance to Advance First Antibody Candidate from its DC-6001 Anti-CD93 Program into Clinical Development (GlobeNewswire) - "DynamiCure...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to advance the first monoclonal antibody candidate from the company’s DC-6001 anti-CD93 development program into a Phase 1 study (NCT05496595). The study is designed to evaluate the safety and efficacy of DCBY02 in adult patients with a wide range of advanced cancers....The Phase 1 program consists of two parts: a dose-escalation phase (Part 1) to determine a recommended Phase 2 dose (RP2D), followed by a dose-expansion phase (Part 2) at the RP2D....DynamiCure plans to submit the IND for the second monoclonal antibody from the DC-6001 program, DCSZ11, in the fourth quarter of 2022."

IND • New P1 trial • Oncology • Solid Tumor