KD6001 / Shanghai Kanda Biotech - LARVOL DELTA

Phase Ib/II clinical study on the safety and efficacy of KD6001 combined with toripalimab in the treatment of advanced melanoma (CSCO 2024) - "Study group: [Organizing Committee]"

Clinical • Metastases • P1/2 data • Melanoma • Oncology • Solid Tumor

A phase I/II study of KD6001, a novel fully human anti-CTLA4 IgG1 monoclonal antibody, in combination with toripalimab in patients with advanced melanoma. (ASCO 2024) - P1/2 | "KD6001 in combination with toripalimab for treatment of advanced melanoma was safe, well-tolerated and showed anti-tumor activity in pts with advanced melanoma. Preliminary analysis indicates that KD6001 combined with toripalimab is efficacious in pts who have progressed after previous anti-PD-1/L1 therapy and in pts with mucosal melanoma."

Clinical • Combination therapy • Metastases • P1/2 data • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

A first-in-human, phase I, dose-escalation study to evaluate pharmacokinetics, safety, and tolerability of KD6001, a novel anti-CTLA-4 monoclonal antibody (mAb) in patients with advanced solid tumors. (ASCO 2024) - P1 | "KD6001 showed promising antitumor activity and a tolerable safety profile in patients with advanced solid tumors. Hence, 3mg/kg was selected as the RP2D. Clinical trial information: NCT05230290."

Clinical • Metastases • P1 data • PK/PD data • Melanoma • Oncology • Solid Tumor

KD6001: A promising new anti-CTLA-4 human monoclonal antibody for cancer therapy (AACR 2024) - "Herein, we present the preclinical pharmacology study of KD6001, a novel anti-CTLA-4 IgG1 kappa human monoclonal antibody with superior properties compared to ipilimumab, a currently approved anti-CTLA-4 mAb. The promising preclinical data presented herein support the further clinical development of KD6001 as a potential therapeutic agent for cancer treatment. Currently, clinical trials evaluating KD6001 in patients with advanced melanoma are ongoing."

IO biomarker • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • CD80 • CD86 • IFNG

KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=85 | Not yet recruiting | Sponsor: Shanghai Kanda Biotechnology Co., Ltd. | Initiation date: Jul 2023 ➔ Apr 2024 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Combination therapy • Metastases • Trial initiation date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=85 | Not yet recruiting | Sponsor: Shanghai Kanda Biotechnology Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Shanghai Kanda Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Melanoma • Oncology • Solid Tumor

Study to Evaluate KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Shanghai Kanda Biotechnology Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Melanoma • Oncology • Solid Tumor

Clinical Study of KD6001 in Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Shanghai Kanda Biotechnology Co., Ltd. | Recruiting ➔ Completed | N=20 ➔ 13

Enrollment change • Metastases • Trial completion • Oncology • Renal Cell Carcinoma • Solid Tumor