danvilostomig (SI-B003) / Biokin Pharma - LARVOL DELTA

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=376 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=159 ➔ 60

Enrollment change • Enrollment closed • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Solid Tumor

BL-B01D1-SI-B003-201-03: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Oct 2025 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Non Nasopharyngeal Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • HER-2 • KRAS • MET • NTRK • ROS1

BL-B01D1-SI-B003-201-02: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

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

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=121 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 ➔ Dec 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Solid Tumor

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=40 ➔ 130 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=98 ➔ 130

Combination therapy • Enrollment change • Metastases • Monotherapy • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Jun 2025 | Trial primary completion date: Aug 2024 ➔ Jun 2025

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=376 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=268 ➔ 376

Combination therapy • Enrollment change • Metastases • Monotherapy • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: May 2024 ➔ Aug 2024

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P2 | N=268 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=190 ➔ 268

Combination therapy • Enrollment change • Metastases • Monotherapy • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=121 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=159 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ May 2024

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=121 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=90 ➔ 121

Combination therapy • Enrollment change • Metastases • Monotherapy • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2