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Poster Display

152P - A Phase I Study of HBM4003, an anti-CTLA-4 Heavy Chain Only Monoclonal Antibody, in Combination with Toripalimab in Advanced Melanoma

Date

08 Dec 2022

Session

Poster Display

Presenters

Tang Bixia

Citation

Annals of Oncology (2022) 16 (suppl_1): 100104-100104. 10.1016/iotech/iotech100104

Authors

T. Bixia1, Z. CHI1, Y. Chen2, Y. Jiang3, M. Fang4, Q. Gao5, G. Huang6, X. Ren7, Y. Yao8, J. Chen9, X. Zhang10, R. Li11, G. Humphrey12, L. Ding12, Y. Geng12, S. Zhao12, Y. Yang12, Z. Lu12, D. Ye12, J. Guo13

Author affiliations

  • 1 Peking University Cancer Hospital and Institute, Beijing/CN
  • 2 Fujian Cancer Hospital, Fuzhou/CN
  • 3 West China School of Medicine/West China Hospital of Sichuan University, Chengdu/CN
  • 4 Zhejiang Cancer Hospital, Hangzhou/CN
  • 5 Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou/CN
  • 6 Hunan Cancer Hospital, Changsha/CN
  • 7 Tianjin Cancer Hospital, Tianjin/CN
  • 8 First Affiliated Hospital of Xi'an Jiaotong University, Xi'an/CN
  • 9 Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan/CN
  • 10 Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 11 The First Affiliated Hospital of Kunming Medical University, Kunming/CN
  • 12 Harbour BioMed, Shanghai/CN
  • 13 Department Of Renal Cancer And Melanoma, Peking University Cancer Hospital and Institute, 100142 - Beijing/CN
More

Abstract 152P

Background

HBM4003 is a fully human heavy chain only monoclonal antibody targeting CTLA-4. In addition to blocking the CTLA-4 pathway, HBM4003 is also engineered to deplete Treg cells by enhanced antibody-dependent cellular cytotoxicity (ADCC) activity that was clinically validated. Here we reported updated results of a phase I study that evaluated HBM4003 plus toripalimab (anti-PD-1 antibody) in advanced melanoma.

Methods

This study includes two parts. In the dose-escalation part, patients with solid tumors received HBM4003 at 3 dose levels (0.03 mg/kg [n=1], 0.1 mg/kg [n=3], and 0.3 mg/kg [n=10]) plus toripalimab 240 mg every three weeks (Q3W). In the dose-expansion part, patients with advanced melanoma (n=26) received the recommended phase 2 dose (RP2D) of HBM4003 0.3 mg/kg plus toripalimab 240 mg Q3W.

Results

As of 27 Jun 2022, a total of 40 patients had been dosed. Median follow-up time was 106.5 days. Treatment-related adverse events (TRAEs) were reported in 85.0% (34/40) patients, and ≥Grade 3 TRAEs were reported in 20.0% (8/40) patients. The most commonly reported TRAE was rash (30.0%). Patients with advanced melanoma treated with RP2D (including 8 patients in Part 1 and 26 patients in Part 2) were categorized as anti-PD-(L)1 naïve group (Cohort A, 17 patients) and anti-PD-(L)1 pretreated group (Cohort B, 17 patients). For cohort A, the ORR and DCR were 53.3% (95%CI: 26.6-78.7) and 73.3% (95%CI: 44.9-92.2) respectively in the 15 patients with post-treatment tumor assessment. The ORR of cutaneous, acral, mucosal and unknown subtype were 66.7% (2/3), 50% (2/4), 60.0% (3/5) and 33.3% (1/3), respectively. For Cohort B, the ORR and DCR were 11.8% (95%CI: 1.5-36.4) and 35.3% (95%CI: 14.2-61.7) respectively, including one patient achieving PR after pseudo-progression. Both of the PR cases were mucosal subtype.

Conclusions

HBM4003 0.3 mg/kg plus toripalimab 240mg Q3W showed promising anti-tumor activity in anti-PD-(L)1 naive patients with advanced melanoma including acral and mucosal subtypes, as well as an acceptable safety profile.

Clinical trial identification

NCT04727164.

Legal entity responsible for the study

Peking University Cancer Hospital.

Funding

Harbour BioMed.

Disclosure

All authors have declared no conflicts of interest.

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